[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Notre Dame\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":197},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,47,80,108,130,153,178],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100644016","phase-2-evaluating-the-effectiveness-of-the-common-elements-treatment-approach-ceta-in-peru-mechanisms-of-individual-and-intergenerational-change-100644016",false,"NCT07667738","Evaluating the Effectiveness of the Common Elements Treatment Approach (CETA) in Peru: Mechanisms of Individual and Intergenerational Change","Inclusion Criteria:\n\n* live in San Juan de Lurigancho, Lima, Peru,\n* be at least 18 years of age,\n* have a child between the ages of 4 and 6, and\n* have the ability to travel to INFAM for study assessments and treatment sessions\n\nExclusion Criteria:\n\n* living outside of San Juan de Lurigancho,\n* those who are unable or unwilling to attend in-person sessions, or\n* the presence of severe intellectual disabilities or mental illness (these individuals will be referred to other local services)",true,"FEMALE","18 Years",{"count":19,"type":20},600,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Recent advances in intervention research have revealed the promise of transdiagnostic, modular approaches implemented by lay paraprofessionals for the treatment of the most prevalent mental health concerns in settings affected by adversity (e.g., anxiety, depression, posttraumatic stress), but to date, few effectiveness trials have examined the indirect effects of treatment on intergenerational and economic outcomes or moderators of treatment effectiveness. There is thus a critical need not only for the continued expansion of the evidence-basis for care in low-resource settings, but also for the evaluation of factors contributing to effectiveness across multiple dimensions to gain a better understanding of the sustainability, long-term benefits, and cost-effectiveness of these approaches. The current study will conduct a rigorous evaluation of an existing program, the Common Elements Treatment Approach (CETA) with women (N=300) who are mothers of young children (ages 4-6). The trial will take place in the context of an integrated community care setting in Lima, Peru's most populous and impoverished district, San Juan de Lurigancho. The primary aims are to (1) evaluate the primary and indirect effects of CETA (2) examine moderators of treatment effectiveness, including implementation quality and neighborhood factors and (3) examine CETA's cost effectiveness. The central hypotheses are that (H1a) CETA will improve women's mental health, intimate partner violence, and parenting and that (H1b) CETA will have indirect benefits for women's economic outcomes and for their children's adjustment. It is also hypothesized (H2) that effectiveness will be enhanced by strong implementation quality and the presence of neighborhood promotive factors, and weakened by neighborhood disadvantage. Hypotheses will be evaluated using an RCT employing a longitudinal design with assessments at baseline (T1), post-test (T2), 6-month follow-up (T3) and 12-month follow-up (T4). Women will be randomized into the intervention condition (CETA + Enhanced Case Management \\[ECM\\]) or the comparison condition (ECM). Robust, multi-source (i.e., participant, therapist, supervisor, census data) and multi-method data (i.e., interview, observational assessment, google street view coding) will be gathered. The contribution will be significant by advancing research on both direct and long-term benefits of maternal mental health care for family systems, and is likely to provide important insights into the sustainability and cost effectiveness of these approaches. The expected outcome is an evidence-based, cost-effective, integrated approach to maternal mental health care that can be readily implemented by local organizations. Further, it is anticipated that learnings from this project will respond to broader global public health concerns and provide opportunity for cross-context reciprocal innovation. Expanding the evaluation of CETA delivered in Spanish not only has advantages for the specific context under study, but provides an important foundation for addressing health disparities in Spanish-language mental health services in the US as well.",[26,27,28,29,30,31,32,33],"Violence","Parenting","Poverty","Depression","Mental Health","Posttraumatic Stress","Economic Factors","Child Psychology","RECRUITING","2026-06-19",{"date":37,"type":38},"2026-06-25","ACTUAL",{"date":40,"type":38},"2026-05-18",{"date":42,"type":20},"2030-04-30",{"name":44,"class":45},"University of Notre Dame","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":46},"100619275","better-experiences-in-substance-treatment-a-brief-alcohol-focused-intervention-tailored-for-patients-in-opioid-agonist-treatment-100619275","NCT07342504","Better Experiences in Substance Treatment: A Brief Alcohol-focused Intervention Tailored for Patients in Opioid Agonist Treatment","Better Experiences in Substance Treatment: A Brief Alcohol-Focused Intervention Tailored for Patients in Opioid Agonist Treatment","Project BEST","Inclusion Criteria for the RCT:\n\n* Participants must be taking prescribed buprenorphine for at least 2 weeks\n* Participants must be 18 years or older.\n* Meet DSM-5 criteria for alcohol use disorder (AUD)\n* Participants must report alcohol use ≥ 1 day\u002Fweek on average in the past 28 days\n* Participants must be able to read simple English\n\nExclusion Criteria:\n\n* Currently receiving formal alcohol use treatment.\n* Currently experiencing psychosis","ALL",{"count":57,"type":20},60,[59],"NA","This study will help determine the feasibility and acceptability of a brief opioid-informed alcohol intervention in patients receiving prescribed buprenorphine for opioid use who are currently drinking alcohol. It will also provide initial information on whether the intervention improves outcomes related to alcohol use. The results of this proof-of-concept study will inform whether a future larger clinical trial is warranted.",[62,63,64,65],"Alcohol Use Disorder","Opioid Use Disorder","Alcohol Use","Opioid Use",[62,67,68,63,69,70,71],"Alcohol Use Disorder (AUD)","Cognitive Behavioral Therapy","Opioid Use Disorder (OUD)","Motivational Enhancement Therapy","Cognitive Behavior Therapy (CBT)","2026-06-05",{"date":74,"type":38},"2026-06-09",{"date":76,"type":38},"2026-03-24",{"date":78,"type":20},"2027-03-01",{"name":44,"class":45},{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":55,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":46},"100604966","restorative-effects-of-sleep-on-everyday-health-and-wellbeing-a-treatment-study-100604966","NCT07156383","Restorative Effects of Sleep on Everyday Health and Wellbeing: A Treatment Study","Effects of CBT-I on Hypothalamic-Pituitary-Adrenal (HPA)-Axis Functioning in Participants With Chronic Insomnia","RESET","Inclusion Criteria:\n\n* At least 18-years-old\n* Speaks English\n* Meets DSM-5 criteria for Insomnia Disorder, determined through initial screener than verified during brief clinical interview (at intake)\n\nExclusion Criteria:\n\n* Sleep disorders other than Insomnia\n* Endocrine disorders\n* Extreme sleep schedule (i.e. shift workers)\n* Currently taking sleep medication\n* Currently taking medication for endocrine dysfunction\n* Currently taking medication that interferes with sleep or cortisol levels\n* Excessive alcohol\u002Fsubstance use or AUD\u002FSUD\n* Serious mental illness\n* Chronic medical conditions (which may be exacerbated by sleep restriction)\n* Pregnant or nursing women\n* Women in the peri-menopausal stage due to irregular menses and fluctuations in sex hormones.",{"count":89,"type":20},115,[59],"The purpose of this study is to evaluate the mechanisms through which Cognitive Behavioral Therapy for Insomnia (CBT-I) leads to improvements in sleep and sleep-related daytime outcomes, specifically as it relates to cortisol and the hypothalamic-pituitary-adrenal (HPA) axis, the body's primary stress response system. The primary research aims are: 1) To determine whether changes in cortisol functioning are related to improvements in sleep consolidation (4-week CBT-I), sleep duration (10-week CBT-I) or both, AND 2) to examine whether these improvements are more pronounced among individuals with insomnia and short sleep duration (compared to insomnia with 'normal' sleep duration).This study will recruit individuals with chronic insomnia: half with reported short sleep duration (less than 6 hours of sleep on an average night) and half with reported non-short sleep duration (6 or more hours per night). Participants will complete an in-lab assessment on four different occasions. During the first visit, they will confirm eligibility, complete an online survey, complete an in-lab stress task (with saliva samples), and provide a hair sample to measure cortisol (a hormone). They will then be sent home with a home sleep test as a final eligibility check (to rule out sleep disorders other than insomnia), an actigraphy watch to measure their sleep, and collection tubes to provide saliva samples to measure cortisol. We will then track the participants' sleep using online daily diaries and actigraphy for four week. Following the 4-week baseline period, participants will come in for a second in-lab visit (same procedures as the first visit) and then be randomized to receive either four or ten weeks of Cognitive Behavioral Therapy for Insomnia (CBT-I). CBT-I is a empirically supported behavioral treatment for insomnia and the first-line treatment for chronic insomnia. Sleep patterns and insomnia symptoms will continue to be monitored via diaries during the intervention phase. The third visit will take place once the participant has completed the intervention and the fourth visit will occur three months following the third visit (3 months post-treatment). The 3rd and 4th visits will again replicate the same procedures conducted during the initial lab visit.",[93],"Chronic Insomnia",[95,96,97,98,99],"Sleep Initiation and Maintenance Disorders","Insomnia Disorder","Sleep Disorders","Cortisol","Sleep Deprivation","2026-04-20",{"date":102,"type":38},"2026-04-23",{"date":104,"type":38},"2025-09-29",{"date":106,"type":20},"2027-08-31",{"name":44,"class":45},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":15,"sex":55,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":46},"100493532","an-evidence-based-family-support-program-for-parents-and-children-in-palestine-a-theory-based-intervention-100493532","NCT05706376","An Evidence-based Family Support Program for Parents and Children in Palestine: A Theory-based Intervention","Inclusion Criteria:\n\n* a willing adolescent between the ages of 13 and 16\n* assuming a two-parent family, a mother and father willing to participate\n* within the service area of implementing organizations\n\nExclusion Criteria:\n\n* Families with individuals with significant mental or physical impairments precluding their ability to participate in groups","12 Years","75 Years",{"count":117,"type":20},900,[59],"Few evidence-based programs exist to support children and families affected by sociopolitical conflict, despite documented evidence of their heightened risk for emotional and behavioral adjustment problems associated with exposure to conflict and violence at multiple levels of the social ecology (e.g., political, community, and family). Thus, a critical need exists for an evidence-based program to ameliorate the impact of political violence on the overall well-being of children and families. The current study will conduct a rigorous evaluation of a theoretically-driven, family-based intervention program in Palestine, including both the West Bank and Gaza. Firmly grounded in the cultural context of Palestine but with broad implications for individuals exposed to sociopolitical violence, the long-term goal of this project is to provide a family-focused intervention program (Promoting Positive Family Futures; PPFF) that may facilitate individuals' sense of safety and support in the context of chronic adversity. The objective is to evaluate this intervention program in the context of a randomized clinical trial (RCT) in the West Bank and Gaza (N=300). The central hypothesis is that the program will have direct positive effects on family conflict, parent psychopathology and parental security in the family as well as on adolescent emotional security in the family, with cascading effects on adolescent adjustment. Consistent with family systems theory, we further hypothesize that treatment effects on parents will mediate on the effects of the treatment on adolescent adjustment. The rationale is that bolstering resilience in family systems is a key approach to promoting positive functioning in families exposed to chronic violence. The hypothesis will be evaluated with three specific aims: 1) evaluate the efficacy of an evidence-based family support program; 2) examine process models of treatment change, and 3) examine interrelations between parent and child functioning. To achieve these aims, the study will be an RCT employing a longitudinal design (N=300) with multi-method assessments at baseline (T1), post-test (T2), 6-month follow-up (T3) and 12-month follow-up (T4). Families included in the study will be evenly divided between the West Bank (n=150) and Gaza Strip (n=150). Families will be randomized into the intervention condition (PPFF) or treatment as usual (TAU). Each territory will have an implementing partner, and implementing partners and investigators will work together to ensure the study procedures are implemented in parallel across sites. Data collection will be conducted by trained research staff from a third-party survey and policy research organization. The proposal seeks to shift current research and clinical paradigms in these contexts by employing novel theoretical concepts, approaches, and methodologies. The contribution will be significant by 1) further developing new directions for empirically-based interventions in these high-risk contexts, and 2) advancing a relatively brief, cost-effective program that can be readily implemented to help children and families exposed to continuing conflict in Palestine, with the potential to be brought to scale in other contexts.",[121,122,123,26],"Adolescent","Psychopathology","Parent-Child Relations",{"date":102,"type":38},{"date":126,"type":38},"2023-09-19",{"date":128,"type":20},"2027-07-31",{"name":44,"class":45},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":15,"sex":55,"minAge":137,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":21,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},"100437785","the-happy-families-project-testing-the-effectiveness-of-a-conflict-resolution-program-for-families-100437785","NCT04980794","The Happy Families Project: Testing the Effectiveness of a Conflict Resolution Program for Families","Effectiveness of an Empirically Supported Family Intervention: Mental Health Outcomes, Mechanisms of Effect, and Organizational Factors","Inclusion Criteria:\n\n* Two parents or primary caregivers\n* Child between 4 and 17 years old\n* English literate\n* Able\u002Fwilling to participate through the 12-month follow up assessment.\n\nExclusion Criteria:\n\n* Families who cannot communicate in English\n* Single parent families","4 Years",{"count":139,"type":20},1800,[59],"This study is designed to test the effectiveness of a psychoeducation-based program to address communication and conflict resolution in families, thereby supporting mental health in children and their caregivers.",[30,143],"Conflict","2024-11-13",{"date":146,"type":38},"2024-11-15",{"date":148,"type":38},"2021-03-01",{"date":150,"type":20},"2025-12-30",{"name":44,"class":45},3,{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":15,"sex":55,"minAge":4,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":162,"conditions":163,"keywords":167,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},"100323783","families-of-youth-with-developmental-disabilities-a-theory-based-intervention-100323783","NCT03495440","Families of Youth with Developmental Disabilities: a Theory-Based Intervention","Inclusion Criteria:\n\n* Participants in all conditions will include mothers, fathers, TD siblings between 11 and 17 years old, and individuals with IDD of any age.\n* Participants must be able to understand and respond to survey questions in English\n* Parents must be cohabitating, with both participating children living in their home.\n* Individual with IDD falls into one or more of the following categories: 1) meets criteria for an intellectual disability, which would mean a measured IQ of 70-75 or lower and a measured Adaptive Functioning score of 70-75 or lower, 2) meets criteria for an Autism Spectrum Disorder based on an evaluation using the ADOS-2, SCQ, and expert clinical judgment based on DSM-5 ASD criteria, or 3) has a medically verified genetic condition (e.g., Down syndrome, Fragile X syndrome, Williams syndrome, Angelman syndrome, others) that is generally considered to be a developmental disability, and shows cognitive or adaptive functioning deficits (70-75 or below) although not necessarily deficits in both categories as would be needed for an Intellectual Disability diagnosis.\n\nExclusion Criteria:\n\n* Siblings identified as typically developing will be excluded 1) with a score of 10 or higher on the SCQ-L, if a subsequent ADOS suggests that they have an ASD diagnosis, or 2) with a WASI-II score of 75 or lower.",{"count":160,"type":20},150,[59],"This study is designed to evaluate a preventive intervention program designed to support families (parents and typically developing adolescent siblings) that include a child with an intellectual and\u002For developmental disability. Participant families will be randomly assigned to either the treatment condition, in which they will receive psychoeducation and communication coaching over a four-week period, or the control condition, in which they will receive self-study materials. All subjects will participate in a pre-test assessment and three post-test assessments over the course of the year.",[164,165,166],"Family Conflict","Marital Conflict","Communication",[168,169,170],"Emotional Security","Intellectual Disability","Developmental Disability",{"date":146,"type":38},{"date":173,"type":38},"2017-08-04",{"date":175,"type":20},"2024-12-31",{"name":44,"class":45},2,{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":15,"sex":55,"minAge":17,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":21,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":152},"100408803","evaluation-of-summit-brush-in-treatment-of-blepharitis-100408803","NCT04603222","Evaluation of SUMMIT BRUSH in Treatment of Blepharitis","Inclusion Criteria:\n\n* Clinical signs and symptoms of blepharitis (Staphylococcal and Demodex).\n* Must exhibit visible collarettes, clear sleeves, and scurfs on the eyelid margins upon Slit Lamp Biomicroscopy.\n\nExclusion Criteria:\n\n* Hordeolum\n* Chalazion\n* Periorbital cellulitis\n* Allergic eyelid dermatitis.\n* Acute bacterial conjunctivitis\n* Open periorbital wounds.",{"count":57,"type":20},[59],"Dry Eye Disease (DED) is a multifactorial disease that affects \\~15-30 million people in the USA alone. It creates an enormous societal and economic burden, decreases productivity in the workplace, and affects the quality of lives of the people affected by this disease. DED is primarily caused by blepharitis, a chronic inflammation of the eyelid margins. If left untreated, blepharitis results in the obstruction and loss of the glands responsible for tear film production. The standard of care is the use of self-administered at home commercially available products, e.g., eyelid foams, gels, and pads. Although these products are helpful, they have limitations. Patients often require expensive in office procedures, e.g., lid debridement with exfoliation devices or more expensive procedures. The scope of this project is to evaluate the effectiveness of a new self-administered disposable ocular brush used in conjunction with the most common eyelid cleanser. The investigators are looking to see if combining the microexfoliation provided by the brush with the eyelid cleanser is more effective at removing the eyelid debris than the cleanser alone.",[188],"Blepharitis","2020-11-24",{"date":191,"type":38},"2020-11-27",{"date":193,"type":38},"2020-07-21",{"date":195,"type":20},"2022-07-18",{"name":44,"class":45},""]