[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fetal-alcohol-spectrum-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fetal-alcohol-spectrum-disorders":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,58,84,104,127,154,173,205,233,260,307],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":35,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100635054","carrii-native-intervention-optimization-trial-100635054",false,"NCT07547696","CARRII Native Intervention Optimization Trial","CARRII Native Intervention Optimization Trial 3-month Factorial Experiment With 512 Participants Randomized to 8 Conditions","Inclusion Criteria:\n\n* Native American\u002FAmerican Indian\u002FAlaska Native,\n* who are not surgically sterile,\n* who report alcohol consumption at risk levels and risk for pregnancy in the past 90 days due to having sex with a man with inconsistent, ineffective, or no contraception.\n* Participants must have access to the Internet via a mobile device they can access daily\n\nExclusion Criteria:\n\n* cognitive disorders including mental retardation, dementia, or psychotic disorders that could impair ability to understand the intervention material or give informed consent.",true,"FEMALE","18 Years","44 Years",{"count":21,"type":22},512,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this study is to identify the best combination of new intervention components to use with CARRII, the first automated online intervention for alcohol-exposed pregnancies (AEP). This intervention is specifically designed for Native women and others who can become pregnant. Our goal is to maximize the effectiveness of the online intervention while keeping costs manageable for Native communities.",[28,29,30,31,32,33,34],"Fetal Alcohol Spectrum Disorders","Pregnancy","Alcohol-Related Disorders","Drinking, Alcohol","Contraception Behavior","Alcohol Exposed Pregnancy","Sexual Behavior",[36,37,38,39,40,41,42,43,44],"Native American","female","adult","contraception","alcohol","digital intervention","mobile health (mHealth)","optimization","risk reduction","RECRUITING","2026-06-18",{"date":48,"type":49},"2026-06-23","ACTUAL",{"date":51,"type":49},"2026-06-02",{"date":53,"type":22},"2028-07-30",{"name":55,"class":56},"University of Virginia","OTHER",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":65,"minAge":18,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":23,"phases":69,"briefSummary":70,"conditions":71,"keywords":72,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":57},"100594174","thrive-person-centered-planning-program-for-young-adults-with-fetal-alcohol-spectrum-disorders-100594174","NCT07016009","Thrive Person-Centered Planning Program for Young Adults With Fetal Alcohol Spectrum Disorders","Randomized Controlled Trial of the Thrive Person-Centered Planning Program for Young Adults With FASD","Inclusion Criteria:\n\n* Young adult between the ages of 18 and 25\n* Lives in the United States\n* Has a diagnosis of fetal alcohol spectrum disorder or confirmed prenatal alcohol exposure\n\nExclusion Criteria:\n\n* Does not have access to the internet or data plan allowing video conferencing\n* Is not able to listen or speak in English","ALL","25 Years",{"count":68,"type":22},60,[25],"This study evaluates the Thrive person centered planning program for young adults with fetal alcohol spectrum disorders. Participants are randomized to either an immediate start or delayed start group for the psychoeducation phase. Following this phase, participants are randomized again to receive the intervention in either an individual or group based format. Participants complete repeated online assessments at multiple timepoints over approximately 10 months to evaluate whether the program improves goal setting, social support, and quality of life.",[28],[73,74],"fetal alcohol spectrum disorders","person-centered planning","2026-04-25",{"date":77,"type":49},"2026-04-30",{"date":79,"type":49},"2026-04-14",{"date":81,"type":22},"2028-08-31",{"name":83,"class":56},"University of Rochester",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":65,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":57},"100565152","my-health-coach-app-rct-100565152","NCT06638463","My Health Coach App RCT","Randomized Controlled Trial of the My Health Coach App for Adults With Fetal Alcohol","Inclusion Criteria:\n\n* adult 18 years or older\n* have a fetal alcohol spectrum disorder (FASD) or history of prenatal alcohol exposure\n* have sufficient fluency in written English\n* own a smartphone\n\nExclusion Criteria:\n\n* participated in the past feasibility trial of the My Health Coach app",{"count":92,"type":22},200,[25],"The goal of this clinical trial is to learn if the My Health Coach app helps adults with fetal alcohol spectrum disorders (FASD). The main questions it aims to answer are:\n\nDoes the My Health Coach app improve the quality of life of adults with FASD? Does the My Health Coach app help adults with FASD manage their day to day life?\n\nAll participants will be asked to complete 3 sets of surveys: 1) at the study start, 2) at 6 weeks, and 3) at 12 weeks. Half of the participants will be given the app at the study start to use. The other half of participants will get the app after the 12 week surveys are complete.\n\nResearchers will compare survey results from people who receive the app right away to those who are in the waitlist group to see if there are changes in quality of life or day to day functioning.",[28],"2026-02-13",{"date":98,"type":49},"2026-02-18",{"date":100,"type":49},"2025-04-01",{"date":102,"type":22},"2026-12-31",{"name":83,"class":56},{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":65,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":57},"100474316","cifasd-5-tdcs-and-cognitive-training-100474316","NCT05456321","CIFASD 5 tDCS and Cognitive Training","tDCS and Cognitive Training as a Neurodevelopmental Intervention in FASD","Inclusion Criteria:\n\n* Documented heavy prenatal alcohol exposure (self-report, social service records, or adoption records) and meeting criteria for an associated FASD diagnosis (FAS, partial FAS, or ARND).\n* An available parent or legal guardian capable of giving informed consent\n\nExclusion Criteria:\n\n* Substance abuse in the participant\n* Neurological condition or other developmental disorder\n* Serious psychiatric disorder known to affect brain functioning and cognitive performance Birthweight \\\u003C 1500 grams\n* MRI contraindication\n* tDCS contraindication","8 Years","17 Years",{"count":114,"type":22},70,[25],"This is a randomized placebo-controlled trial of cognitive training with transcranial direct current stimulation (tDCS) for children and adolescents (ages 8 - 17 years) with prenatal alcohol exposure (PAE).",[28],"2026-01-16",{"date":120,"type":49},"2026-01-20",{"date":122,"type":49},"2022-11-10",{"date":124,"type":22},"2027-05-31",{"name":126,"class":56},"University of Minnesota",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":65,"minAge":111,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":137,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":57},"100581196","trigeminal-nerve-stimulation-for-children-with-prenatal-alcohol-exposure-100581196","NCT06847165","Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure","TNS-PAE","Inclusion Criteria:\n\n* \\- Fetal alcohol syndrome, partial fetal alcohol syndrome, or alcohol-related neurodevelopmental disorder per modified Institute of Medicine criteria (thus positive maternal drinking in pregnancy required, facial stigmata not required)\n* Prenatal alcohol exposure (PAE) \\>6 drinks\u002Fweek for \\>= 2 weeks and\u002For \\>= 3 drinks on \\>= 2 occasions throughout gestation per Health Interview for Women\u002FHealth Interview for Adoptive and Foster Parents (HIW\u002FHIAFP)\n* Diagnosis of Diagnostic and Statistical Manual 5th edition (DSM-5) attention deficit hyperactivity disorder (ADHD), including problems with inattention, hyperactivity, impulsivity, and\u002For executive function. Screening for ADHD will be done using the Swanson, Nolan, and Pelham Teacher and Parent Rating Scale (SNAP IV). Formal diagnosis of ADHD will be based on the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) with input from the Behavior Rating of Executive Function (BRIEF II) and the Conners 4.\n* Parent and child able to complete testing in English\n* Child able to cooperate during MRI\n* Full-Scale Intelligence Quotient \\>70 per the Kaufman Brief Intelligence Test (K-BIT-2)\n* Child able to comply with study procedures\n* Age 8-12\n\nExclusion Criteria:\n\n* \\- Other toxic exposure per HIW\u002FHIAFP whose influence clearly surpasses that of alcohol (very rare) per study clinician judgement\n* Known genetic syndrome associated with ADHD-like symptoms including fragile X, tuberous sclerosis, or generalized resistance to thyroid hormone\n* Serious medical or neurologic illness likely to influence brain function, e.g., seizures, closed-head trauma\n* Gestation \\\u003C 34 weeks\n* Ferromagnetic metal, claustrophobia, or other MRI or TNS contraindication (e.g., insulin pumps or other body-worn devices)\n* Diagnosis of autism spectrum disorder, psychotic disorder, or major mood disorder\n* Active suicidal ideation as evidenced by meeting criteria for \"Current\" or \"Lifetime attempt\" on the Suicidality module or \"Current' or 'In early remission' on the Suicide Behavior Disorder module of the MINI KID","12 Years",{"count":136,"type":22},30,[25],"This is an open-label trial of trigeminal nerve stimulation (TNS) for children aged 8-12 years with attention deficit hyperactivity disorder (ADHD) putatively due to prenatal alcohol exposure (PAE). TNS has been successful in treating pediatric ADHD generally and it is US Food and Drug Administration (FDA)-cleared for this condition. But this will be the first time it is tried for ADHD specifically associated with PAE. In TNS, a weak electric current is applied to the child's forehead overnight while sleeping to gently stimulate the brain. TNS is administered at home by the parent to the child. TNS is safe and well tolerated. Efficacy of TNS in ADHD is \\~50%. The purpose of the present pilot study is to determine the feasibility of TNS for children with PAE and ADHD. Feasibility means safety (any serious side effects?), tolerability (do children comply with TNS? are they comfortable with it?), and a rough idea of efficacy (does TNS seem to work in most kids?) A secondary goal of the study is to get a more precise idea of brain mechanisms of TNS with magnetic resonance imaging (MRI). Families who participate will make three clinic visits: eligibility (4-5 hours), pre-TNS (2-3 hours including MRI), and post-TNS (2-3 hours including MRI). Children will receive TNS, applied by the parent, for 8 hours every night while sleeping for 4 weeks. Four weeks after treatment, families will take part in a telephone follow-up, to see whether any improvements made last.",[28,140],"Attention Deficit Hyperactivity Disorder",[142,143,144],"prenatal alcohol exposure","attention deficit hyperactivity disorder","trigeminal nerve stimulation","2025-06-29",{"date":147,"type":49},"2025-07-01",{"date":149,"type":49},"2025-04-26",{"date":151,"type":22},"2026-09-30",{"name":153,"class":56},"University of California, Los Angeles",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":16,"sex":65,"minAge":18,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":57},"100513053","families-moving-forward-fmf-connect-pro-for-mental-health-providers-100513053","NCT05960461","Families Moving Forward (FMF) Connect Pro for Mental Health Providers","Inclusion Criteria:\n\n* Licensed mental health provider or supervised trainee\n* Employed by a community mental agency or in private practice\n* provides mental health services to children ages 3 to 12 or their families\n* provides services in the United States\n* Fluency in English\n* Access to the internet\n\nExclusion Criteria:\n\n* Provides services outside of the United States\n* Does not provide mental health services to children ages 3 to 12",{"count":161,"type":22},250,[25],"The goal of this clinical trial is to test a new provider-assisted version of the caregiver Families Moving Forward (FMF) Connect app (\"FMF Connect Pro\") with mental health providers in the United States. In FMF Connect Pro, mental health providers learn to do routine screening for prenatal alcohol exposure, diagnose fetal alcohol spectrum disorders (FASD), and support families in using the FMF Connect caregiver app.\n\nTwo different training methods will be compared with a waitlist group in this study. The first training method involves 13-sessions of tele-mentoring using an Extension of Community Healthcare Outcomes (ECHO) approach. The second training method involves a self-directed approach in which providers will access similar content in any asynchronous format on a website.\n\nThe main questions this study aims to answer are:\n\n* What is the proportion of agencies and providers who accept and participate in the clinical trial (Reach)?\n* Do study groups differ on provider outcome measures of Effectiveness (clients screened\u002Fdiagnosed), Adoption (provider change in knowledge, self-efficacy), Implementation (practice change, FMF Connect Pro Dashboard usage), and Maintenance of FASD-informed care practice change?\n\nAll mental health providers in the study will complete online assessments at study entry, 6 months, and 12 months.",[28],"2025-06-02",{"date":167,"type":49},"2025-06-05",{"date":169,"type":49},"2024-03-22",{"date":171,"type":22},"2027-04-30",{"name":83,"class":56},{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":65,"minAge":181,"maxAge":18,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":185,"conditions":186,"keywords":190,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":57},"100492002","psychoeducation-of-parents-to-children-with-fasd-100492002","NCT05686473","Psychoeducation of Parents to Children With FASD","Evaluation of a Treatment Program Based on Psychoeducation of Parents of Children and Adolescents With Fetal Alcohol Spectrum Disorder (FASD)","NorFASDPEdu","All children and adolescents (age 2,5-18 years) referred to the Regional Competence Centre for children with prenatal alcohol exposure in Arendal, Norway will be invited to participate in the current research project.\n\nInclusion criteria:\n\n* Valid information about alcohol exposure in fetal life. Exceptions to this inclusion criterion are children who have been adopted and with dysmorphic features that are consistent with full Fetal Alcohol Syndrome.\n\nExclusion Criteria:\n\n* Children with known genetic syndromes, progressive brain and neuromuscular diseases or major sensory defects (blindness or deafness).","2 Years",{"count":183,"type":22},75,[25],"By longitudinal, prospective research in children and adolescents with Fetal Alcohol Spectrum Disorders (FASD) and their parents to explore the beneficial effects of participating in a standardized intervention program in order to treat and reduce the consequences of early brain damage. By using elements from international programs based on psychoeducation and parent training, the investigators aim to help parents to better understand and respond to the neurodevelopmental disabilities of their children, and thereby improving behavioral problems and self-regulation deficits.",[28,187,188,189],"Behavior Problem","Adaptive Behavior","Learning Disorders",[191,192,193,194],"FASD","Psychoeducation","Parenting","Information program","2025-05-16",{"date":197,"type":49},"2025-05-21",{"date":199,"type":49},"2025-05-01",{"date":201,"type":22},"2026-12",{"name":203,"class":204},"Sorlandet Hospital HF","OTHER_GOV",{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":16,"sex":65,"minAge":18,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":23,"phases":215,"briefSummary":217,"conditions":218,"keywords":220,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":57},"100392836","phase-2-rct-of-prenatal-choline-supplementation-during-pregnancy-to-mitigate-adverse-effects-of-prenatal-alcohol-exposure-100392836","NCT04395196","RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure","A Randomized, Double-Blind, Placebo-controlled Clinical Trial of Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure on Growth and Cognitive Development","Inclusion Criteria:\n\n* Age ≥18 yr\n* ≤20 wk gestation\n* Singleton pregnancy\n* Currently heavy drinking (average of ≥15 ml AA\u002Fday or binge drinking (≥4 standard drinks\u002Foccasion) on at least 1.5 occasions\u002Fmonth on average since becoming pregnant)\n* Current choline dietary intake \\\u003C1 g\u002Fday\n* Language fluency in English or Afrikaans\n\nExclusion Criteria:\n\n* Use of methamphetamine or other illicit drugs other than marijuana during the past year\n* HIV positive\n* Pharmacologic treatment for a serious pre-existing medical condition (e.g., diabetes, hypertension, epilepsy, or cardiac problems)\n* Having another child enrolled in the trial from a previous pregnancy\n* Plans for mother or child to move away from the area prior to study completion","45 Years",{"count":214,"type":22},288,[216],"PHASE2","Although the adverse effects associated with prenatal alcohol exposure (PAE) are well known, many women continue to drink heavily during pregnancy, putting their infants at risk for fetal alcohol spectrum disorders. Animal studies have shown that choline supplementation can mitigate effects of PAE on growth and development. Choline, an essential nutrient, serves as a methyl-group donor for DNA methylation and is a constituent of the neurotransmitter acetylcholine and a precursor to major components of cell membranes. In an R21 feasibility trial, 70 heavy drinkers were randomly assigned to receive a daily dose of 2g of choline or a placebo from initiation of antenatal care to delivery in Cape Town, South Africa, where the incidence of heavy drinking during pregnancy and fetal alcohol syndrome are among the highest in the world. When compared with infants in the placebo arm, infants in the choline-treated arm were more likely to meet criterion for eyeblink conditioning, demonstrated markedly better recognition memory on the Fagan Test of Infant Intelligence, which is known to have predictive validity for school-age IQ, and had better postnatal gains in weight and head circumference. Key features of this study included the higher choline dose (4.4 times adequate intake (AI), compared to 1.7-2.5 in previous human studies) and initiation of treatment early in pregnancy. We are now conducting a fully-powered, double-blind, randomized, placebo-controlled choline supplementation trial in heavy drinking pregnant women from a rural community in South Africa (1) to assess the effectiveness of maternal choline supplementation during pregnancy to mitigate effects of PAE on three primary outcomes: infant recognition memory and postnatal growth restriction (weight and head circumference); (2) to assess the efficacy of this supplementation for mitigating alcohol effects on the following secondary outcomes: infant eyeblink conditioning, postnatal length, and information processing speed; (3) to use innovative methods in causal inference analysis to examine protocol adherence as an important source of variation in treatment efficacy and to identify sociodemographic factors associated with non-compliance in order to facilitate implementation of the intervention protocol in clinical settings; and (4) in exploratory analyses, to examine whether maternal choline supplementation is particularly effective in women with lower dietary choline intake or poor nutritional status.",[28,219],"Fetal Alcohol Syndrome",[221,222,223,224],"Prenatal Alcohol Exposure","Choline Supplementation","Infant Neurodevelopment","Growth","2025-03-25",{"date":100,"type":49},{"date":228,"type":49},"2023-04-13",{"date":230,"type":22},"2028-05-15",{"name":232,"class":56},"Wayne State University",{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":16,"sex":65,"minAge":18,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":23,"phases":243,"briefSummary":245,"conditions":246,"keywords":247,"overallStatus":250,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":4},"100564943","phase-1-dose-escalation-study-of-vinpocetine-in-healthy-volunteers-100564943","NCT06635746","Dose Escalation Study of Vinpocetine in Healthy Volunteers","Phase I, Open Label, Dose-Escalation Study for Maximum Tolerated Vinpocetine Dose in Healthy Volunteers","Inclusion Criteria:\n\n1. Healthy adults 18-40 years old.\n2. Proficient English.\n3. Use of appropriate contraception if woman of childbearing potential.\n\nExclusion Criteria:\n\n1. Major medical disease (e.g., epilepsy, diabetes, heart disease, active cancer, depression).\n2. Those who score \\>18 overall on the BDI-II or \\>0 for item #9 (suicidal thoughts) at screening.\n3. Use of centrally active medications.\n4. History of allergy to vinpocetine.\n5. IQ\\\u003C80.\n6. BMI≥30.\n7. Pregnancy or lactation.","40 Years",{"count":242,"type":22},20,[244],"PHASE1","The objective of this study is to determine whether vinpocetine is safe when taken at higher doses.",[28],[248,249],"Cognition","Vinpocetine","NOT_YET_RECRUITING","2024-10-08",{"date":253,"type":49},"2024-10-10",{"date":255,"type":22},"2025-06-01",{"date":257,"type":22},"2026-06-01",{"name":259,"class":56},"Stanford University",{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":23,"phases":268,"briefSummary":269,"conditions":270,"keywords":286,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":306},"100480329","the-oklahoma-parent-child-assistance-program-100480329","NCT05534568","The Oklahoma Parent-Child Assistance Program","A Randomized Controlled Trial of the Parent-Child Assistance Program in Oklahoma","Inclusion Criteria:\n\n* 18 years or older\n* Women who have used alcohol, opioids, or other drugs during pregnancy\n* Women who are (1) pregnant or have a child under 24 months old who was exposed to substances and are not well connected to community services or (2) have a child with fetal Alcohol Spectrum Disorder and are currently with at-risk alcohol use and in childbearing years\n* Resides in Oklahoma City, Oklahoma or Tulsa, Oklahoma\n\nExclusion Criteria:\n\n* Not meeting eligible criteria above\n* Incarcerated at the time of enrollment\n* Enrollment in similar services (i.e., ReMerge, Systems of Care (SOC) and\u002For Family Treatment Courts (FTC) and heading to Termination of Parental Rights (TPR))\n* If the participant is receiving services from the Substance use Treatment and Recovery (STAR) Prenatal Clinic and is part of the research, their enrollment in PCAP will be delayed until STAR Prenatal Clinic graduation",{"count":92,"type":22},[25],"The Parent-Child Assistance Program (PCAP) helps mothers who have used alcohol, opioids, or other drugs during pregnancy and their children through the work of highly trained, closely supervised case managers. Case managers work closely with mothers over the course of three years, meeting the mothers in their own homes when possible, to help them to set goals and take advantage of available resources. The primary aims of PCAP include: (1) assisting mothers in obtaining substance use disorder (SUD) treatment and staying in recovery, (2) linking mothers to community resources that will help them build and maintain healthy, independent family lives for themselves and their children, and (3) preventing future drug and alcohol use during pregnancy.\n\nThis study brings PCAP to Oklahoma (the state with the highest incarceration rate for women, where most enter the criminal justice system for drug charges) for the first time. This five-year project includes 200 women who will enroll in the study and be randomly assigned to the treatment (100 women) or control group (100 women). The intervention (i.e., PCAP services) will take place over a three-year period at two sites: Oklahoma City, Oklahoma and Tulsa, Oklahoma.\n\nThis evaluation will measure participants' substance use, substance use disorder (SUD) treatment outcomes, and a host of other well-being outcomes-including but not limited to subsequent substance-exposed births, use of public assistance, education, use of family planning methods, and employment-to evaluate the effects of PCAP services. Among these, the investigators have identified four key outcomes: (1) the mother is on a reliable method of birth control, (2) abstinence for six months, (3) child custody (i.e., placement of children in foster care and\u002For with kinship providers), and (4) criminal justice involvement.",[271,272,273,274,275,276,277,278,28,219,279,280,281,282,283,284,285],"Substance Use Disorders","Pregnancy Related","Alcohol Use Disorder (AUD)","Alcohol Use Complicating Pregnancy, First Trimester","Alcohol Use Complicating Pregnancy, Second Trimester","Alcohol Use Complicating Pregnancy, Third Trimester","Alcohol Use Complicating Pregnancy, Unspecified Trimester","Alcohol Use Complicating Pregnancy, Childbirth, and the Puerperium","Drug Use Disorders","Drug Use Complicating Pregnancy, First Trimester","Drug Use Complicating Pregnancy, Second Trimester","Drug Use Complicating Pregnancy, Third Trimester","Drug Use Complicating Pregnancy, Unspecified Trimester","Drug Use Complicating Pregnancy, Childbirth, and the Puerperium","Maternal Drugs Affecting Fetus",[287,288,289,290,291,292,293,294,295,296],"Parent-child assistance","Substance use disorder","addictions","drug dependence","drug abuse","alcohol dependence","alcohol abuse","alcoholism","recovery services","PCAP","2024-06-05",{"date":299,"type":49},"2024-06-07",{"date":301,"type":49},"2022-11-15",{"date":303,"type":22},"2026-11-15",{"name":305,"class":56},"University of Oklahoma",2,{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":65,"minAge":111,"maxAge":315,"enrollmentInfo":316,"targetDuration":4,"studyType":23,"phases":318,"briefSummary":319,"conditions":320,"keywords":321,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":57},"100516489","the-synchrony-study-examining-music-training-for-children-with-fasd-100516489","NCT06005181","The Synchrony Study: Examining Music Training for Children With FASD","The Synchrony Study: A Randomized Controlled Trial of Music Training for Children With a Fetal Alcohol Spectrum Disorder (FASD)","Synchrony","Inclusion Criteria:\n\n* Children must receive a research designation of FASD\n* Children must have confirmed prenatal alcohol exposure\n\nExclusion Criteria:\n\n* Children with other confirmed developmental disorders that are not deemed associated with FASD (e.g. autism spectrum disorder, Down Syndrome). Children with attention deficits (e.g. ADHD) are not excluded.\n* Children with neurological disorders (epilepsy, cerebral palsy, etc.)\n* Children who have experienced a traumatic brain injury with loss of consciousness \\>10 minutes\n* Children with intelligence quotient scores \\\u003C70\n* Children who are, or become, a ward of the state; however children with a legal representative who can consent on their behalf will not be excluded\n* Children with ongoing music training outside of school or \\>1 year of prior private music lessons.","16 Years",{"count":317,"type":22},32,[25],"The goal of this clinical trial is to examine if music training improves behavioral or cognitive performance in children with prenatal alcohol exposure who meet research criteria for a fetal alcohol spectrum disorder. The main questions it aims to answer are:\n\n* Does music training improve behavioral regulation for children with an FASD\n* Does music training improve cognitive performance (attention and working memory) for children with an FASD.\n\nThe study has two interventions for each participant: music listening and piano training. Each participant will either practice piano daily for 12 weeks or listen to pre-selected music daily for 12 weeks. The order of the interventions will be randomized across participants. Assessment will occur before and after participation in each 12 week intervention.",[28],[322,323,324,325],"music training","music listening","piano training","attention","2024-03-12",{"date":328,"type":49},"2024-03-15",{"date":330,"type":49},"2023-10-02",{"date":332,"type":22},"2028-09",{"name":334,"class":56},"The Mind Research Network"]