[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Vanderbilt University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":404},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,48,79,102,124,154,179,200,225,253,274,300,325,351,381],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100258681","phase-1-metabolic-effects-of-angiotensin-1-7-100258681",false,"NCT02646475","Metabolic Effects of Angiotensin-(1-7)","Inclusion Criteria:\n\n* Males and females of all races between 18 and 60 years of age\n* Obesity defined as body mass index between 30-40 kg\u002Fm2\n* Insulin resistance defined as homeostasis model assessment 2 insulin resistance (HOMA2-IR) score \\>2.2\n* Hypertension defined by two or more properly measured seated blood pressure readings \\>130\u002F85 mmHg, or by use of anti-hypertensive medications. This blood pressure cutoff will allow us to include subjects with pre-hypertension.\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Pregnancy or breast-feeding\n* Current smokers or history of heavy smoking (\\>2 packs\u002Fday)\n* History of alcohol or drug abuse\n* Morbid obesity (BMI \\> 40 kg\u002Fm2)\n* Previous allergic reaction to study medications\n* Evidence of type I or type II diabetes (i.e. fasting glucose \\>126 mg\u002Fdl, use of anti-diabetic medications)\n* Cardiovascular disease other than hypertension such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy\n* History of serious cerebrovascular disease such as cerebral hemorrhage, stroke, or transient ischemic attack\n* History or presence of immunological or hematological disorders\n* Impaired hepatic function \\[aspartate amino transaminase (AST) and\u002For alanine amino transaminase (ALT) \\> 2.0 x upper limit of normal range\\]\n* Impaired renal function (serum creatinine \\>1.5 mg\u002Fdl)\n* Anemia (hemoglobin \\\u003C13.5 g\u002Fdl in males or \\\u003C12.5 g\u002Fdl in females)\n* Treatment with serotonin-norepinephrine reuptake inhibitors (SNRIs) or norepinephrine transporter (NET) inhibitors\n* Treatment with phosphodiesterase 5 inhibitors\n* Treatment with anticoagulants\n* Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)\n* Treatment with any investigational drug in the 1 month preceding the study\n* Inability to give, or withdraw, informed consent\n* Other factors which in the investigator's opinion would prevent the subject from completing the protocol (i.e., clinically significant abnormalities on clinical, mental examination or laboratory testing or inability to comply with protocol)","ALL","18 Years","60 Years",{"count":19,"type":20},26,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The overall purpose of this study is to learn more about the metabolic effects of angiotensin-(1-7) in the insulin resistant state associated with obesity. Pharmacologic approaches to increase angiotensin-(1-7) levels or its actions are currently in development for treatment of metabolic-related diseases such as obesity and type II diabetes, based on findings from animal studies. It is unclear if this peptide contributes to the regulation of metabolism in humans. The investigators will test if angiotensin-(1-7) infusion can improve insulin sensitivity measured by hyperinsulinemic-euglycemic clamp methods in individuals with obesity and insulin resistance. The investigators will also examine for changes in blood pressure and related hemodynamic and hormonal changes following angiotensin-(1-7) infusion.",[26,27,28,29],"Obesity","Insulin Resistance","Hypertension","Metabolic Cardiovascular Syndrome",[31,32,33,34],"renin-angiotensin system","angiotensin","insulin resistance","blood pressure","RECRUITING","2026-05-18",{"date":38,"type":39},"2026-05-22","ACTUAL",{"date":41,"type":39},"2016-02",{"date":43,"type":20},"2029-12",{"name":45,"class":46},"Vanderbilt University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":15,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":47},"100604961","drumming-lessons-influence-on-children-with-down-syndrome-100604961","NCT07156318","Drumming Lessons' Influence on Children With Down Syndrome","Effects of Drumming Lessons on Brain and Behavior in Children With Down Syndrome","Inclusion Criteria:\n\n* Down syndrome\n\nExclusion Criteria:\n\n* Already taken drumming lessons\n* Uncorrected hearing loss\n* Uncorrected vision loss","7 Years","15 Years",{"count":58,"type":20},30,[60],"NA","The goal of this clinical trial is to learn if drumming lessons can increase self-control in children with Down syndrome. The main question it aims to answer is whether 2 months of drumming lessons can improve the behavioral control and timing skills in children with Down syndrome. Participants are between 7 and 15 years of age and receive two months of drumming lessons given by a professional drummer with extensive experience working with children with Down syndrome. Children in the experimental group visit our lab once before lessons start and once after lessons are completed. Children in the control group visit our lab twice before they start their lessons. Lab visits include brain recordings taken using a net-style cap, computer tasks, and drumming to music.",[63],"Down Syndrome",[65,66,67,68,69,70],"Children with Down syndrome;","Effects of drumming lessons","Effects on brain and behavior","Inhibitory control","Beat perception","Intervention study","2026-05-15",{"date":73,"type":39},"2026-05-19",{"date":75,"type":39},"2026-02-15",{"date":77,"type":20},"2027-12",{"name":45,"class":46},{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":15,"minAge":85,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":47},"100551777","whole-foods-for-teens-a-pilot-dietary-intervention-to-reduce-body-adiposity-in-adolescents-with-obesity-100551777","NCT06464497","Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity","Inclusion Criteria:\n\nFor this study, eligible adolescents will be those that:\n\n1. 10-18 years of age at time of initial screening;\n2. living at home full-time with the enrolled parent or caregiver (≥80% in primary residence);\n3. obesity defined as a body mass index (BMI) greater than or equal to 95th percentile for age and gender based on standardized CDC growth curves;\n4. reside within greater Middle Tennessee area and has enrolled parent\u002Fcaregiver willing to drive to Vanderbilt University and Vanderbilt University Medical Center for study visits;\n5. are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy to 3 or more food groups causing anaphylaxis);\n6. are willing and able to participate in an 8-week diet study that encourages preparing and eating healthy foods and snacks for 8 weeks with parental or caregiver support;\n7. have parental or caregiver commitment to participate in the research study;\n\nFor this study, eligible adult parents or caregivers will be those that:\n\n1. adult parent or primary legal caregiver (greater than or equal to 25 years of age) of an enrolled adolescent;\n2. live with the adolescent full-time (≥80% in primary residence);\n3. have 1 or more metabolic risk factor(s) and\u002For metabolic condition(s) (e.g., overweight\u002Fobesity, hypertension, hypercholesterolemia or dyslipidemia, hyperglycemia \\[elevated fasting blood glucose ≥100 mg\u002FdL\\] and\u002For prediabetes, history of gestational diabetes, polycystic ovarian syndrome, type 2 diabetes, non-alcoholic fatty liver disease);\n4. reside within greater Middle Tennessee area and are willing to drive to Vanderbilt University and Vanderbilt University Medical Center for study visits;\n5. are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy to 3 or more food groups);\n6. are able to participate in a study program that encourages preparing and eating healthy foods and snacks for 8 weeks with most preparation\u002Fcooking of meals\u002Fsnacks at home;\n\nExclusion Criteria:\n\nAdolescent exclusion criteria include:\n\n1. Outside of the specified age range;\n2. not living in the home of the enrolled parent or caregiver full time (≥80% in primary residence);\n3. BMI less than 95th percentile for age and gender;\n4. pregnant or lactating;\n5. no eligible enrolled parent or caregiver or lack of parental\u002Fcaregiver commitment to participate in study;\n6. food allergy to 3 or more food groups; dietary restrictions or medical condition that prohibits participation in a diet study;\n7. use of medications that cause weight loss or diabetes medications;\n8. active participation in a weight loss or intense lifestyle modification program;\n9. limited English-language proficiency;\n10. participants unwilling or unable to give informed consent, accept random assignment, attend dietary counseling sessions, adhere to treatment prescription, or complete study measures;\n11. adolescents who display dissenting behaviors during baseline data collection;\n12. adolescents who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;\n\nAdult Parent or Caregiver exclusion criteria include:\n\n1. not parent\u002F or legal caregiver;\n2. not living in a household full-time with enrolled adolescent (less than 80% time spent away from primary residence);\n3. lack of metabolic condition(s) per inclusion criteria;\n4. special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;\n5. limited English-language proficiency;\n6. participants unwilling or unable to give informed consent, accept random assignment, attend dietary counseling sessions, adhere to treatment prescription, or complete study measures;\n7. parent or caregivers who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;","10 Years",{"count":87,"type":20},60,[60],"This study will address the following aims:\n\nAim 1: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on body adiposity in adolescents with obesity.\n\nAim 1a (Primary): Evaluate intervention effectiveness on total fat mass following the 8-week intervention.\n\nHypothesis 1a: Adolescents randomized to the whole foods intervention will have lower total fat mass (kg) at the 8-week follow-up than those in the control group.\n\nAim 1b: Evaluate intervention effectiveness on anthropometric changes following the 8-week intervention.\n\nHypothesis 1b: Adolescents randomized to the whole foods intervention will have lower weight, BMI-z scores and\u002For waist circumference at the 8-week follow-up than those in the control group.\n\nSecondary Aims:\n\nAim 2: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on diet quality in adolescent and parent pairs during the study period.\n\nHypothesis 2: Adolescents and parents randomized to the whole foods intervention will have higher diet quality scores at the 8-week follow-up than those in the control group.\n\nAim 3: Conduct post-intervention family focus groups to identify how individual\u002Ffamily needs and preferences and social determinants of health (SDOH) may be perceived barriers and\u002For facilitators of diet adherence to a whole foods diet pattern.",[91,92,93],"Obesity, Childhood","Diet, Healthy","Body Weight Changes","2026-03-18",{"date":96,"type":39},"2026-03-23",{"date":98,"type":39},"2025-03-24",{"date":100,"type":20},"2027-04-30",{"name":45,"class":46},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":15,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":47},"100553196","whole-food-for-families-a-pilot-rct-of-a-dietary-guidelines-based-intervention-to-prevent-type-2-diabetes-100553196","NCT06482944","Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes","Inclusion Criteria:\n\nFor this study, eligible adults will be those that:\n\n1. are 25 to 59 years of age at time of initial screen and identify as a parent to at least one child or adolescent 6-18 years;\n2. have a body mass index of between ≥23kg\u002Fm2 to \\\u003C40kg\u002Fm2;\n3. have prediabetes (based on American Diabetes Association criteria of either fasting plasma glucose of ≥100 mg\u002FdL, HgbA1c 5.7-6.4%, or 2-hour plasma glucose during 75-g oral glucose tolerance test \\[OGTT\\] 140 mg\u002FdL to 199 mg\u002FdL) with recent lab values reported within the prior 6-12 months and confirmed by an HbA1c A1cNow+ collected prior to enrollment (\\*see comment below);\n4. have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods\u002Fbeverages;\n5. are English speaking;\n6. reside in Greater Nashville Tennessee and willing to come to Vanderbilt campus and Vanderbilt University Medical Center for required study visits;\n7. are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy causing anaphylaxis);\n8. are able to participate in a 12-week dietary program that requires home preparation\u002Fcooking for meals and snacks;\n\nFor this study, eligible offspring will be those that:\n\n1. Are 6-18 years at time of initial screen;\n2. Have an index parent with prediabetes that is actively enrolled in the program;\n3. have body mass index ≥5th percentile for age and gender on standardized CDC growth curves;\n4. have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods\u002Fbeverages;\n5. have parental commitment to participate in a 12-week research study\n6. are English speaking;\n7. reside in the Greater Nashville Tennessee area and live at home with their index parent during the duration of 12- week study;\n8. are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy causing anaphylaxis);\n9. are able to participate in a 12-week dietary program that includes at least dinner and snacks provided during after-school hours;\n\nExclusion Criteria:\n\nAdult exclusion criteria include:\n\n1. Adults who's HbA1c test is outside of the HbA1c range during screening\\* (see details related to screening results)\n2. adults outside the specified age range of \\\u003C25 years or \\>59 years;\n3. adults whose body mass index is \\\u003C23kg\u002Fm2 or those with a body mass index ≥40kg\u002Fm2 as that degree of morbid obesity represents a different phenotype where dietary behavioral intervention alone may not be sufficient to achieve weight loss);\n4. receiving care by a healthcare provider (i.e., MD, NP, PA) for a complicated diagnosis of prediabetes that requires routine glycemic monitoring or frequent healthcare visits for management\u002Ftreatment;\n5. adults actively participating in any type of weight loss program (dietary or physical activity)\n6. adults with a prior history of type 2 diabetes;\n7. adults who are not English speaking or have limited English-language proficiency;\n8. adults with special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;\n9. adults with serious mental or neurologic illness that impairs the ability to consent\u002Fparticipate;\n10. women who are pregnant or nursing due to increased metabolic state requiring greater energy requirements;\n11. adults currently taking medications to treat diabetes or to promote weight loss;\n12. adults living outside Greater Nashville Tennessee or who are unwilling to travel to Vanderbilt for study visits;\n13. adults who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;\n\nOffspring (child\\[ren\\] and adolescent\\[s\\]) exclusion criteria include:\n\n1. children\u002Fadolescents outside the specified age range of \\\u003C6 years or \\>18 years;\n2. children\u002Fadolescents whose body mass index is \\\u003C5th percentile for age and gender on standardized CDC growth curves;\n3. children\u002Fadolescents who do not have an eligible index parent participating in the study;\n4. children who do not have parental commitment to participate consistently for 12-weeks\n5. children\u002Fadolescents who are not English speaking or have limited English-language proficiency;\n6. children\u002Fadolescents with special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;\n7. children\u002Fadolescents who display dissenting behaviors during baseline data collection;\n8. children\u002Fadolescents actively participating in any type of weight loss program (medical or lifestyle);\n9. children\u002Fadolescents who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;","6 Years","59 Years",{"count":58,"type":20},[60],"This study will address the following aims:\n\nAim 1 (primary): Conduct a pilot RCT to evaluate the feasibility, acceptability, enrollment, and retention rates of adult-child pairs after a 12-week family-centered, non-calorie restricted whole foods diet.\n\nFeasibility: ≥80% participant retention and completion of study outcome measures.\n\nAcceptability: ≥75 adult diet satisfaction via survey report and\u002For perceived diet satisfaction via focus groups. Aim 2: Conduct a pilot RCT to evaluate the preliminary effectiveness of a non-calorie restricted whole foods diet on adult HbA1c at 12 weeks and adult\u002Fchild diet quality during the 12-week intervention.\n\nAim 2a: Evaluate intervention effects on HbA1c measures in adults with prediabetes.\n\nHypothesis 2a: Adults randomized to the treatment group will have lower HbA1c measures at 12 weeks than those in the control group.\n\nAim 2b: Evaluate intervention effects on the diet quality (via the 2020 HEI) of adults and children. Hypothesis 2b: Adults and children randomized to the treatment group will have a higher diet quality score during the 12-week intervention period compared to adults and children in the control group.\n\nAim 3: Conduct family focus groups to understand how SDOH and individual\u002Ffamily needs and preferences may be perceived barriers or facilitators of diet adherence.",[114,92,115],"PreDiabetes","Nutritional and Metabolic Diseases","2026-03-05",{"date":118,"type":39},"2026-03-06",{"date":120,"type":39},"2025-10-13",{"date":122,"type":20},"2027-06-30",{"name":45,"class":46},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":135,"conditions":136,"keywords":139,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":151,"leadSponsor":153,"locationsCount":47},"100562085","evaluation-of-mbct-implemented-in-vietnamese-buddhist-pagoda-100562085","NCT06598579","Evaluation of MBCT Implemented in Vietnamese Buddhist Pagoda","Evaluation of the Effectiveness of Mindfulness-Based Cognitive Therapy for Depression, Implemented in Vietnamese Buddhist Pagoda","MBCT-VN","Inclusion Criteria:\n\n* Age 18 years or older\n* PHQ-9 greater than or equal to 10\n* PHQ-9 sadness item greater than or equal to 1, and \u002F or PHQ-9 anhedonia item greater than or equal to 1\n\nExclusion Criteria:\n\n* PHQ-9 greater than or equal to 20\n* suicidal intent\n* mania or psychosis",{"count":133,"type":20},160,[60],"Background\n\nDepression presents a substantial public health burden around the world. Evidence-based psychotherapy treatments (psychotherapy EBT) for depression exist but access is often limited, particularly in low- and middle-income countries (LMIC), by mental health stigma and scarcity of professional mental health providers. One approach to address these issues is mental health task-shifting, transferring mental health services from highly trained mental health professionals operating in formal mental health settings, to non-mental health professionals or lay people receiving focused training in a particular mental health program, operating in non-mental health settings (e.g., schools; religious settings). Purposes of the present study are to (a) adapt Mindfulness-Based Cognitive Therapy (MBCT) for depression - a psychotherapy depression EBT - for implementation in Vietnamese Buddhist pagoda in VN (MBCT-VN); and (b) conduct a cluster-randomized clinical trial of MBCT-VN, implemented in Vietnamese Buddhist pagoda. Vietnamese Buddhist pagoda are selected as the task-shifting site because they represent a potentially low stigma, culturally-congruent site for task-shifting implementation of mindfulness-based mental health treatments.\n\nMethods\n\nMBCT was adapted for the present project through a collaborative team process, producing the MBCT-VN program. The clinical trial evaluation will involve a cluster-randomized comparison between (a) the treatment condition MBCT-VN, and (b) a treatment-as-usual control condition, Buddhist meditation as implemented in pagoda. To reduce cross-group contamination, pagoda will be the unit of assignment. Outcome assessments will include four timepoints across four months. One hundred and sixty adult participants will be recruited from eight (four treatment; four control) Buddhist pagoda in the Hanoi, Vietnam area. The primary outcome will be level of depression (Patient Health Questionnaire-9: PHQ-9); the secondary outcome will be quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire: Q-LES-Q). The study will assess and evaluate several Implementation Science factors (e.g., Treatment Acceptability) as well as other potential moderators of treatment effects, and potential mediators such as increase in depression mental health literacy and decrease in depression stigma. Inferential analyses will use a general linear mixed model framework with a latent growth curve framework, with propensity covariates.",[137,138],"Depressive Symptoms","Quality of Life",[140,141,142,143,144,145],"Depression","Mindfulness","Buddhist meditation","MBCT","Vietnam","task-shifting","NOT_YET_RECRUITING","2025-12-20",{"date":149,"type":39},"2025-12-23",{"date":75,"type":20},{"date":152,"type":20},"2026-10-15",{"name":45,"class":46},{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":15,"minAge":108,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":163,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":47},"100609912","understanding-cognitive-academic-bidirectionality-in-math-learning-disabilities-100609912","NCT07220746","Understanding Cognitive-Academic Bidirectionality in Math Learning Disabilities","Inclusion Criteria:\n\n* Attends a participating school in the Metropolitan-Nashville Public Schools\n* Is a member of a first-grade classroom whose teacher has agreed to let his\u002Fher students participate\n* Has the available school schedule to participate\n* Scores below the 30th percentile on the study's screening math test\n* Scores below the 50th percentile on the study's working memory test\n* Scores at or above the 7th percentile on at least one of the study's two measures of cognitive performance\n\nExclusion Criterion:\n\n* Does not attend a participating school in the Metropolitan-Nashville Public Schools\n* Is not a member of a first-grade classroom whose teacher has agreed to let his\u002Fher students participate\n* Does not have the available school schedule to participate\n* Scores at or above 30th percentile on the study's screening math test\n* Scores at or above the 50th percentile on the study's screening working test\n* Scores below the 7th percentile on both of the study's two measures of cognitive performance","8 Years",{"count":162,"type":20},300,[60],"The goal of this clinical trial is to test the effects of an innovative intervention designed to improve math skills in first graders at risk for math disabilities. The main questions the trial aims to answer are:\n\n* Does combining a math word problem solving intervention with a working memory intervention improve math to a greater extent than the same math intervention without cognitive training?\n* Do the findings provide evidence for bidirectional effects on development? In other words, does working memory support math learning and does math learning support working memory development?\n\nScreening for eligibility will take place in two testing sessions. Students who meet the eligibility criteria will be randomly assigned to one of three groups:\n\n1. One treatment group will receive a validated treatment for math word problem solving plus computerized working memory training.\n2. Another treatment group will receive the same validated math treatment plus computerized reading instruction.\n3. A control group will receive the conventional school math program, including any additional school-provided intervention.\n\nParticipants in both treatment groups will receive 35 minutes of tutoring three times per week for 15 weeks.\n\nChildren who are selected to participate in the study will be tested once before this project's intervention begins; twice after intervention starts; twice after intervention ends; and once near the end of second grade to see how long effects last.",[166],"Math Learning Disability",[168,169,170],"math word problem solving","arithmetic","working memory","2025-10-23",{"date":173,"type":39},"2025-10-24",{"date":175,"type":39},"2025-08-01",{"date":177,"type":20},"2030-04-30",{"name":45,"class":46},{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":15,"minAge":186,"maxAge":56,"enrollmentInfo":187,"targetDuration":4,"studyType":21,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":47},"100582185","sentence-shaping---dhh-100582185","NCT06860022","Sentence Shaping - DHH","Sentence Shaping: Written Language Intervention for Deaf and Hard of Hearing Middle Schoolers","Inclusion Criteria:\n\n* Children in grades five through eight\n* deaf or hard of hearing\n* use spoken English and American Sign Language (ASL)\n* bilateral hearing loss\n* the ability to read and understand the grammatical structures of interest\n* already be writing sentences, but demonstrate errors in word order and\u002For grammar.\n\nExclusion Criteria:\n\n* diagnosis of dyslexia\n* uncorrected vision impairment (i.e., identified vision loss without use of corrective lenses that interferes with eligibility evaluation tasks)\n* evidence of severe motor impairment (i.e., insufficient motor skills to complete eligibility evaluation tasks independently).","9 Years",{"count":58,"type":20},[60],"The proposed research addresses a long-standing and important challenge of improving literacy skills of children who are deaf and hard of hearing, a historically under researched group. The investigators aim to leverage shape coding - an empirically validated intervention approach for constructing sentences in spoken English - for improving how efficiently children who are deaf and hard of hearing learn to correctly construct sentences in written English. To advance the promising yet underutilized research on shape coding, the investigators complete the next logical step of applying the visual supports provided with shape coding to written language for deaf and hard of hearing children. Shape coding has been effective for teaching sentence structure in spoken English to children with language disabilities and has recently been applied to sentence structure in American Sign Language with deaf and hard of hearing children. Intervention involving shape coding is predicted to result in increased accuracy of word order in sentences in written English because deaf and hard of hearing children often benefit from visual information. The investigators will accomplish this aim using single case multiple probe across participants design studies with 30 fifth through eighth grade children who are deaf and hard of hearing. The knowledge gained will guide language and literacy intervention for children who are deaf and hard of hearing.",[191],"Hearing Loss, Bilateral","2025-10-20",{"date":194,"type":39},"2025-10-22",{"date":196,"type":39},"2025-08-28",{"date":198,"type":20},"2026-10",{"name":45,"class":46},{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":15,"minAge":207,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":21,"phases":211,"briefSummary":212,"conditions":213,"keywords":214,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":47},"100474294","cbt-enhanced-with-social-cognitive-training-vs-cbt-only-with-depressed-youth-100474294","NCT05456035","CBT Enhanced With Social Cognitive Training vs. CBT Only With Depressed Youth","Social Cognitive Training to Enhance the Efficacy of CBT forDepression in Youth: A Developmental Approach (R33)","Inclusion Criteria:\n\n1. Participants ages 13- through 17-years-old\n2. Youth must have a diagnosis of a current depressive disorder (e.g., major depressive episode; persistent depressive disorder) or a score on the Patient Health Questionnaire (PHQ9) \\> 15\n\nExclusion Criteria:\n\n* ever met criteria for a diagnosis of bipolar disorder, schizophrenia, autism, or conduct disorder\n* current alcohol or substance use disorder with significant impairment\n* imminent risk of suicide\n* reading level \\\u003C 4th grade","13 Years","17 Years",{"count":210,"type":20},82,[60],"Depression in youth is a serious public health concern for which more personalized treatments are needed. This randomized controlled trial will test the effect of an intervention aimed at enhancing social cognitive capacities (e.g., ability to take another's perspective), thereby making treatment of depression in youth more efficient and effective. Participants in the R33 (N=82) will be youth between ages 13- through 17-years-old currently experiencing depression. Youth will be randomized to either an enhanced CBT intervention that teaches social cognitive skills, particularly social perspective taking and theory of mind (CBTSCT) as compared to CBT only. The primary target is improvement in both social cognitive skills and depressive symptoms at post-treatment and at a 6-month follow-up.",[140],[140,215,216],"Adolescents","Cognitive behavior therapy","2025-09-02",{"date":219,"type":39},"2025-09-09",{"date":221,"type":39},"2022-10-10",{"date":223,"type":20},"2026-08",{"name":45,"class":46},{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":233,"sex":15,"minAge":234,"maxAge":208,"enrollmentInfo":235,"targetDuration":4,"studyType":21,"phases":237,"briefSummary":238,"conditions":239,"keywords":242,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":252},"100556511","a-randomized-controlled-trial-testing-the-effect-of-the-youth-mindful-awareness-program-on-negative-affect-ymap2-100556511","NCT06526052","A Randomized Controlled Trial Testing the Effect of the Youth Mindful Awareness Program on Negative Affect (YMAP2).","Targeting Negative Affect Through Mindfulness Training in Youth at Risk for Internalizing Problems (R33)","YMAP2","Inclusion Criteria:\n\n* Ages 12, 13, 14, 15, 16, 17\n* Parental Consent\n* Participant Assent\n* Live in Illinois, California, or Tennessee\n\nExclusion Criteria:\n\n* current diagnosis of an anxiety or depressive disorder with significant clinical impairment\n* current alcohol or substance use disorder\n* current serious suicidal ideation or behavior\n* lifetime diagnosis of bipolar disorder, schizophrenia, autism, conduct disorder, or developmental delay\n* reading level below 4th grade\n* not English speaking at a level that would allow them to participate in the intervention and assessments",true,"12 Years",{"count":236,"type":20},360,[60],"The goal of this randomized clinical trial is to compare the effects of an online mindfulness program to an active supportive comparison condition and a no-intervention control group on reducing and preventing mood and anxiety symptoms in at-risk youth. Youth who are high on trait negative affect will be randomized to one of the three conditions. The primary outcomes of interest are reductions in momentary negative affect and internalizing problems in adolescents ages 12 to 17 years old. All participants will be evaluated prior to being randomized, after the 9-session intervention period, and at a 6-month follow-up.\n\nThe first hypothesis is that the mindfulness intervention will predict decreases in stressor-reactive momentary negative affect and internalizing symptoms. The second hypothesis is that changes in momentary negative affect will partially account for the effects of the mindfulness intervention on internalizing symptoms.",[240,241],"Prevention","Control",[215,141,243],"Internalizing","2025-08-14",{"date":246,"type":39},"2025-08-20",{"date":248,"type":39},"2024-04-01",{"date":250,"type":20},"2027-04",{"name":45,"class":46},3,{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":233,"sex":15,"minAge":260,"maxAge":186,"enrollmentInfo":261,"targetDuration":4,"studyType":21,"phases":263,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":47},"100340485","executive-function-in-early-childhood-100340485","NCT03713125","Executive Function in Early Childhood","Early Academic Achievement and Intervention Response: Role of Executive Function","Inclusion Criteria:\n\n1. Children in Kindergarten (approximate ages 4-9 years)\n2. Native English speakers\n\nExclusion Criteria:\n\n1. Children not in Kindergarten at time of enrollment;\n2. previous diagnosis of Intellectual Disability;\n3. known uncorrectable visual impairment;\n4. documented hearing impairment greater than or equal to a 25 decibel (dB) loss;\n5. medical contraindication to MRI procedures (e.g., metal devices) - excludes from MRI procedures only;\n6. known intelligence quotient (IQ) below 70;\n7. a pervasive developmental disorder; and\n8. any known neurologic pathology, including epilepsy, spina bifida, cerebral palsy, traumatic brain injury, and brain tumors.\n9. Comorbid severe psychiatric disorders will also be excluded, as will those who are taking psychotropic medications, with the exception of stimulant medication for Attention Deficit Hyperactivity Disorder (ADHD). Children who meet criteria for ADHD will be eligible as long as they are not taking psychotropic medications, with the exception of stimulant medication for ADHD.","4 Years",{"count":262,"type":20},260,[60],"Despite the fact that a substantial number of school age children struggle with both reading and math acquisition, the brain mechanisms of the overlapping aspects of reading and math skills, thought in part to be linked via executive functions (EF), have not been unpacked. This project will use a longitudinal design, following children from Kindergarten through 1st grade, to understand how the brain networks associated with reading, math, and EF interact to predict academic outcomes and, in those who struggle academically, intervention response.",[266],"Reading Disability","2025-08-08",{"date":244,"type":39},{"date":270,"type":39},"2019-08-13",{"date":272,"type":20},"2026-07-31",{"name":45,"class":46},{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":233,"sex":15,"minAge":16,"maxAge":281,"enrollmentInfo":282,"targetDuration":4,"studyType":21,"phases":284,"briefSummary":285,"conditions":286,"keywords":287,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":47},"100479478","noninvasive-brain-stimulation-to-enhance-reading-comprehension-ability-in-adults-100479478","NCT05523505","Noninvasive Brain Stimulation to Enhance Reading Comprehension Ability in Adults","Bridging the Gap Between Brain Network Science and High-definition Non-invasive Brain Stimulation to Develop a Scalable Adult Literacy Intervention","Inclusion Criteria:\n\nThis study will be open to all right-handed, native English monolingual speakers, who meet eligibility criteria regardless of race, gender, minority or socioeconomic status. Due to age-related differences in the language and learning processes, the age range of subjects will be a minimum of 18 years and a maximum of 40 years.\n\nExclusion Criteria:\n\nWe will exclude individuals with a personal medical history of stroke or seizures or those taking medications specifically prescribed for the treatment of stroke or seizures. However, participants who are on medications that carry an associated risk of stroke or seizures but are not prescribed for these conditions (e.g., anticonvulsants prescribed for pain or behavioral reasons) will remain eligible. Exclusion criteria will be determined by follow-up telephone screenings conducted by lab KSP and is as follows:\n\n1. previous diagnosis of Intellectual Disability;\n2. known uncorrectable visual impairment;\n3. documented hearing impairment greater than or equal to a 25 dB loss;\n4. medical contraindication to MRI procedures (e.g., metal devices);\n5. known IQ below 70;\n6. a pervasive developmental disorder;\n7. any known neurologic pathology, including epilepsy, spina bifida, cerebral palsy, traumatic brain injury, and brain tumors;\n8. recent medical diagnosis of migraines;\n9. pregnancy;\n10. history of syncope;\n11. severe fatigue,\n12. bilingualism or low English proficiency;\n13. poor reading ability that will prevent completion of the tasks; and\n14. comorbid severe psychiatric disorders will be excluded;\n15. a personal medical history of stroke or seizures;\n16. hair styles that do not allow for proper EEG net fitting, or that pose potential risks for damage to EEG net","40 Years",{"count":283,"type":20},100,[60],"The goal of this project is to address the urgent need for effective, scalable adult literacy interventions by integrating breakthroughs in two separate fields: 1.) the brain network science of resilience to reading disorders and 2.) high-definition non-invasive brain network stimulation. This study will first establish the efficacy of a novel, noninvasive stimulation protocol on reading behavior and brain metrics; then will determine how stimulation-induced effects interact with baseline reading comprehension ability; and lastly, will identify whether stimulation-induced effects are more clinically-beneficial than canonical behavioral interventions. Results may change the foundation for how we treat low adult literacy, and have the potential for wider reaching impacts on non-invasive stimulation protocols for other clinical disorders.",[266],[288,289,290,291,292],"Neuroimaging","Adults","Non-invasive Brain Stimulation","Reading","Reading Comprehension","2025-07-29",{"date":175,"type":39},{"date":296,"type":39},"2022-11-07",{"date":298,"type":20},"2026-09-10",{"name":45,"class":46},{"id":301,"slug":302,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":233,"sex":15,"minAge":306,"maxAge":307,"enrollmentInfo":308,"targetDuration":4,"studyType":310,"phases":4,"briefSummary":311,"conditions":312,"keywords":314,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":47},"100083312","providing-access-to-the-visual-environment-100083312","NCT00341744","Providing Access to the Visual Environment","Inclusion Criteria:\n\nChildren age 3 to 21 years of age Enrollment in a school in Tennessee (private or public)\n\n\\- Children that are eligible for services due to visual impairment Low vision\n\nExclusion Criteria:\n\n* Children who do not have the potential to become readers or use their vision for reading","3 Years","21 Years",{"count":309,"type":20},795,"OBSERVATIONAL","Providing Access to the Visual Environment is a pediatric low vision grant which has the ability to provide comprehensive, interdisciplinary low vision rehabilitation services to every child in Tennessee with a vision impairment. Children, ages 3-21, with best-corrected vision of 20\u002F50 or worse in the better seeing eye are prescribed optical devices to improve their visual functioning and trained to use the devices.",[313],"Vision Impairment",[315,316],"Vision","Aids","2025-07-02",{"date":319,"type":39},"2025-07-08",{"date":321,"type":39},"2001-07",{"date":323,"type":20},"2028-12",{"name":45,"class":46},{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":15,"minAge":260,"maxAge":85,"enrollmentInfo":332,"targetDuration":4,"studyType":21,"phases":334,"briefSummary":335,"conditions":336,"keywords":338,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":350,"locationsCount":47},"100588077","project-pair-parent-implemented-articulation-intervention-with-recast-100588077","NCT06936696","Project PAIR: Parent-implemented Articulation Intervention With Recast","Project PAIR","Inclusion Criteria:\n\n* Age 4;0-9;11\n* Permanent, prelingual sensorineural hearing loss\n* Uses spoken English as their primary home language (≥ 51% of the time)\n* Standard score ≥70 on the Leiter\n* Standard score ≥70 on the OWLS-II Listening Comprehension\n* At least two speech sound errors appropriate to target based on speech norms and general stimulability\n\nExclusion Criteria:\n\n* Motor speech disorder (e.g., childhood apraxia of speech)\n* Oral structural functional disorder (e.g., cleft palate)\n* Diagnosis of autism spectrum disorder\n* Diagnosis of ADHD\n* Uncorrected vision impairment (i.e., identified vision loss without the use of corrective lenses)",{"count":333,"type":20},10,[60],"Using a single-case multiple baseline across participants design, this study aims to explore the effectiveness of parent-implemented Broad Treatment Speech Recast supplemented with traditional clinician-led articulation therapy on speech production in elementary-aged deaf and hard of hearing children.\n\nTo address these objectives, the following research questions will be investigated:\n\n1. Does drill-based articulation therapy, administered by a speech-language pathologist, improve speech sound production in DHH children when parent-implemented BTSR is concurrently utilized at home?\n2. Does the combination of parent-implemented BTSR and clinician-led traditional articulation therapy result in generalization of speech sound accuracy at the conversation level?",[337],"Hearing Impaired Children",[339,340,341,342,343],"deaf and hard of hearing","articulation","speech sound production","parent training","children","2025-06-26",{"date":346,"type":39},"2025-06-29",{"date":348,"type":39},"2025-06-10",{"date":223,"type":20},{"name":45,"class":46},{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":21,"phases":360,"briefSummary":361,"conditions":362,"keywords":366,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":47},"100540985","growing-strong-study-of-unconditional-cash-transfers-plus-peer-support-for-families-with-babies-in-homeless-shelters-100540985","NCT06323967","Growing Strong Study of Unconditional Cash Transfers Plus Peer Support for Families With Babies in Homeless Shelters","Growing Strong Study of Unconditional Cash Transfers Plus Voluntary Peer Support to Reduce Shelter Stays and Improve Family Well-being for Families With Babies in New York City Homeless Shelters","Note that New York City has a right to shelter. When a family applies for shelter, the City assigns them to a shelter temporarily while City workers determine whether the family is truly homeless. If so, the City will deem the family \"eligible\" for shelter. If not, the family must leave.\n\nInclusion Criteria:\n\n* A family has been found \"eligible\" for shelter (as described above) within the past 30 days\n* The family has a baby who meets the age criteria (under 2 years of age)\n* There is an adult 18 or over who has custody of the child (typically the mother)\n* The family speaks English or Spanish\n* The family lives in a designated Win shelter\n\nExclusion Criteria:\n\n* None: any family configuration is permissible",{"count":359,"type":20},200,[60],"The Growing Strong program tests a novel approach to helping families with young children living in homeless shelters, namely offering guaranteed, unconditional cash gifts that families can use as they wish plus voluntary peer support. The assumption behind this approach is that families know best how to allocate resources to meet their own individual needs. While there are a number of Direct Cash Transfer studies taking place around the country, the investigator(s) are unaware of any that have tested the relationship of receiving cash on homelessness among families specifically. To be eligible to participate in the study, families must reside in a homeless shelter and have at least one child under two years of age living with them in shelter. The investigator(s) have tied eligibility to the age of the youngest child in the household because rates of shelter use are highest among this population and because the costs associated with young children increase such families' financial burdens.\n\nA total of 200 families will be enrolled in the study. One hundred families in the active intervention group will receive $1,500 per month (\"substantial cash\") for 24 months ($18,000 annually) and may also elect to receive peer support services. One hundred families in the active comparison group will receive $50 per month (\"nominal cash\") for 24 months ($600 annually) and will not have access to the peer support services. A third, passive comparison group will receive usual care within the homeless shelter system in the same metropolitan area (New York City) as participants in both cash gift groups. This group of families will be followed only in administrative records.\n\nThe main research questions are: does providing substantial, unconditional cash transfers plus access to voluntary peer support services over 24 months a) reduce the length of time in shelter for families with young children and\u002For b) improve other aspects of family and child well-being relative to providing nominal cash transfers alone or usual care.",[363,364,365],"Time to Shelter Exit","Family Well-being","Child Well-being",[367,368,369,370,371,372],"family homelessness","direct cash transfer","unconditional cash transfer","housing affordability","income inequality","child poverty","2025-06-24",{"date":375,"type":39},"2025-06-27",{"date":377,"type":39},"2024-05-21",{"date":379,"type":20},"2028-08-30",{"name":45,"class":46},{"id":382,"slug":383,"hasResults":11,"nctId":384,"briefTitle":385,"officialTitle":385,"acronym":386,"eligibilityCriteria":387,"healthyVolunteers":11,"sex":15,"minAge":388,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":21,"phases":391,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":403},"100517237","telehealth-enhanced-patient-oriented-recovery-trajectory-after-intensive-care-100517237","NCT06014931","Telehealth-enhanced Patient-oriented Recovery Trajectory After Intensive Care","TelePORT","Inclusion Criteria:\n\n* Adults (age ≥45)\n* Admitted to a medical or surgical ICU\n* Treated for ARF (with mechanical ventilation) and\u002For septic shock (with vasopressors)\n\nExclusion Criteria:\n\n* hospice care at discharge or not expected to survive 6 months\n* no access to a computer or electronic device (e.g., tablet, smart phone) with cellular or WiFi connection for a telemedicine clinic visit\n* substance abuse or psych disorder that prevents independent living\n* inability to speak English\n* severe dementia preventing independent living prior to index hospitalization","45 Years",{"count":390,"type":20},202,[60],"Intact cognitive skills are necessary for independent living, going to work, and managing finances, and any loss of cognitive skills places a burden on society akin to what is seen with Alzheimer's Disease and Related Dementias. The TelePORT Study (Telehealth-Enhanced Patient-Oriented Recovery Trajectories after Intensive Care) is the first post-intensive care syndrome longitudinal long-term cognitive impairment intervention study. The societal effect from long-term cognitive impairment after critical illness is great as many of these patients are employable adults or functional retirees.",[394],"Post-intensive Care Syndrome","2025-06-09",{"date":397,"type":39},"2025-06-12",{"date":399,"type":39},"2024-03-13",{"date":401,"type":20},"2028-05-31",{"name":45,"class":46},2,""]