[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The National Center on Addiction and Substance Abuse at Columbia University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":118},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,67,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100547900","family-support-protocol-for-adolescent-internalizing-disorders-100547900",false,"NCT06413979","Family Support Protocol for Adolescent Internalizing Disorders","Testing the Feasibility of a Family-based Adjunctive Treatment Protocol for Targeting Co-Occurring Internalizing Disorders Among Adolescents With SUD","Fam-AID","Inclusion Criteria:\n\n* Youth is age 13-21.\n* Youth lives with a primary caregiver who can attend treatment sessions.\n* Youth endorses one or more DSM-5-TR symptoms for SUD and meets American Society of Addiction Medicine criteria for outpatient SU treatment.\n* Youth meets DSM-5-TR criteria, or has elevated symptoms and impairment, for any of the following IDs: Current or Recurrent Major Depressive Episode, Pervasive Depressive Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder, Panic Disorder, Posttraumatic Stress Disorder.\n* Youth completes intake and is enrolled as an active case at study site\n\nExclusion Criteria:\n\n* Illness requiring hospitalization\n* Current psychotic symptoms\n* Severe SU problems that require immediate relief (detox or residential placement)\n* Pervasive developmental disorder.","ALL","13 Years","21 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"NA","This R34 will develop and test an adjunctive treatment protocol for addressing co-occurring internalizing disorders among adolescents enrolled in usual care for substance use problems. Internalizing disorders (ID), primarily depression and anxiety, are highly prevalent among youth receiving community-based treatment for substance use disorder (SUD). Comorbidity rates range from 30-70% due to the multiple developmental pathways by which adolescent SUD and ID cause and exacerbate one another. Moreover, unresolved ID issues significantly interfere with youth SUD treatment and recovery processes. Yet, the youth SUD clinical workforce is not systematically educated or trained in evidence-based practices for ID; thus, line services for youth SUD do not systematically target ID. The research literature offers a few integrated behavioral models for simultaneously treating both SUD and ID in youth; however, such models feature intensive manualized procedures that have proven cumbersome to scale and deliver in frontline settings. As a result, the clinical workforce, though desiring ID-focused training, currently has inadequate resources for treating ID effectively.\n\nA promising solution to diminish this quality gap is developing an adjunctive, modular protocol to augment routine care for comorbid SUD\u002FID by directly targeting ID as a key treatment goal: Family Support Protocol for Adolescent Internalizing Disorders (Fam-AID). As an adjunctive protocol, Fam-AID will not require clinicians to markedly alter existing base practices for SUD. It will be anchored by three evidence-based foundations for treating co-occurring adolescent ID. First, it prioritizes family engagement in services and family-oriented treatment goals, which have been shown to enhance outcomes for youth SUD and ID alike. Second, it is a modular protocol that features core elements of manualized treatment for ID; core element interventions enhance treatment effectiveness by fostering implementation feasibility and sustainability in usual care. Third, it seeks to reinforce the family safety net to prevent teen self-harm. In accord with these foundations, and pending pilot development, we anticipate that Fam-AID will contain five treatment modules that can be delivered in any sequence to meet client needs: (1) Family Engagement of caregivers and primary supports in treatment planning and services; (2) Relational Reframing of family constraints, resiliencies, and social capital connected to the youth's ID symptoms; (3) Functional Analysis of the youth's ID symptoms and related behaviors; (4) Cognitive-behavioral therapy (CBT) core techniques to address the youth's ID symptoms and functional needs, featuring three transdiagnostic interventions (emotion acceptance, emotional exposure, behavioral activation) to address negative affect and emotional dysregulation underlying both depression and anxiety; and (5) Family Psychoeducation and Safety Planning focused on education about comorbid SUD\u002FID and prevention of youth self-harm. All interventions featured in each module have strong empirical support.\n\nThe Fam-AID protocol will contain several innovations intended to boost treatment feasibility and impact for this vulnerable group. Aligned with the core elements strategy, it will be designed for uptake by all motivated clinicians regardless of their clinical orientation and training. It will use evidence-based family engagement techniques to systematically integrate caregivers in the treatment process; typically, families are not centralized in SUD services for youth despite compelling empirical and clinical rationale to do so. It will feature a treatment customization exercise in which clients and therapists collaboratively select CBT techniques to integrate in ongoing treatment based on functional ID assessment.\n\nTo achieve study aims we will first develop a Fam-AID implementation toolkit during a three-part Pilot Phase at one pilot site: (a) Solicit provider input on Fam-AID components; (b) Create video-based training and fidelity procedures, leveraging the PI's existing online therapist training and consultation resources in core CBT techniques for adolescent SUD, as well as the Co-I's equivalent training resources for adolescent ID; (c) Pilot the toolkit with 4-6 clients. In Years 2-3 we will conduct an Interrupted Time Series Study for N = 60 SUD\u002FID cases across two sites serving diverse youth: 30 will receive TAU, and then following line staff training, 30 new cases will receive TAU enhanced by adjunctive Fam-AID. Aim 1: Feasibility will examine Fam-AID cases for acceptability via client and therapist interviews and fidelity benchmarks via therapist- and observer-report of module coverage and protocol dose. Aim 2: Outcomes will test TAU vs. TAU + Fam-AID for immediate impact on family member attendance and ultimate impacts on adolescent ID symptoms at 3- and 6-month follow-up.",[28,29],"Internalizing Disorders","Substance Use Disorders","RECRUITING","2026-04-14",{"date":33,"type":34},"2026-04-17","ACTUAL",{"date":36,"type":34},"2025-07-29",{"date":38,"type":22},"2027-03-31",{"name":40,"class":41},"The National Center on Addiction and Substance Abuse at Columbia University","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":66,"locationsCount":4},"100564066","home-visitation-enhancing-linkages-project-in-kansas-100564066","NCT06624332","Home Visitation Enhancing Linkages Project in Kansas","Digital Screening and Brief Intervention for Perinatal Substance Use in Home Visiting","HELP","Inclusion Criteria:\n\n* English-speaking\n* Age 18 years old or older\n* Gave birth to a baby within the prior year\n* Enrolled in a Healthy Families Kansas program with a participating home visitor\n* Not currently enrolled in substance use treatment\n\nExclusion Criteria:\n\n* Does not speak English\n* Under age 18 years\n* Did not give birth to a baby within the prior year\n* Not enrolled in a Healthy Families Kansas program with a participating home visitor\n* Currently enrolled in substance use treatment",true,"FEMALE","18 Years",{"count":54,"type":22},120,[25],"The goal of this study is to learn about whether digital screening and brief intervention can help address substance use in postpartum mothers who are enrolled in home visiting programs. The main questions it aims to answer are:\n\n1. What combination of digital intervention components work best for postpartum mothers in home visiting programs?\n2. What are the factors that help the intervention work best in home visiting, and what factors serve as barriers to the success of the intervention? Participants in the study will include home visiting staff and postpartum home visiting clients.\n\nParticipants who are home visitors will be asked to participate in focus groups and interviews, introduce the study to their clients and refer interested clients to the study, complete online surveys, and implement the home visitor components of the intervention with their clients who enroll in the study.\n\nParticipants who are home visiting clients will be asked to participate in focus groups and interviews, complete online surveys, and complete the digital screening and brief intervention sessions.",[58],"Substance Use","NOT_YET_RECRUITING","2026-03-16",{"date":62,"type":34},"2026-03-18",{"date":64,"type":22},"2026-06-01",{"date":38,"type":22},{"name":40,"class":41},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":50,"sex":17,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100513326","primary-connections-for-youth-and-families-100513326","NCT05964010","Primary Connections for Youth and Families","Adolescent-Only SBI Versus Family-Based SBI in Primary Care for Adolescent Alcohol Use","PCYF","Inclusion Criteria:\n\n* Youth aged 12-17 years with a primary caregiver (i.e., parental figure) also in attendance to primary care appointment\n* Youth and caregiver are fluent in English or Spanish\n* Youth and caregiver are capable of using audio-assisted informed consent procedures and independently operating a hand-held tablet device\n* Youth and caregiver are complete routine site AOD risk screening questions prompted during PC visit intake","12 Years","17 Years",{"count":78,"type":22},2300,[25],"The goal of this clinical trial is to compare a standard adolescent-only approach to substance use screening, brief intervention, and referral to treatment to a in primary care settings. Primary outcomes (AOD use, co-occurring behavior problems, parent-youth communication about AOD use) and secondary outcomes (adolescent quality of life, therapy attendance) are assessed at screen\u002Finitial and 3, 6, 9, and 12 months follow-up.",[58],[83,84,85,86,87,88],"adolescent substance use","pediatric primary care","screening","brief intervention","referral to treatment","family-based",{"date":62,"type":34},{"date":91,"type":34},"2024-03-01",{"date":93,"type":22},"2029-12",{"name":40,"class":41},1,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":105,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":4},"100561504","phase-1-helpline-pilot-factorial-trial-100561504","NCT06591026","Helpline Pilot Factorial Trial","Helpline Delivery of Brief Interventions for Postpartum Heavy Episodic Drinking","Inclusion Criteria:\n\n* Resides full-time in the United States\n* Age 18-45 years\n* Gave birth to an infant within the prior 4 weeks\n* Speaks and reads English\n* Owns a text-enabled cell-phone\n* Receives a score of 2 or more on the T-ACE alcohol risk screener\n* Reports ONE of the following: (a) drinking weekly or more often in the prior month; or (b) having 4 or more standard drinks at one time at least monthly in the 12 months prior to becoming pregnant.\n\nExclusion Criteria:\n\n* Resides outside of the United States\n* Age under 18 years or over 45 years\n* Did not give birth to an infant within the prior 4 weeks\n* Cannot speak and read English\n* Does not own a text-enabled cell-phone\n* Does not receive a score of at least 2 on the T-ACE alcohol risk screener\n* Does not report either drinking weekly or more often in the past month or having 4 or more standard drinks at least monthly in the 12 months prior to becoming pregnant\n* Scores greater than 4 on the AUDIT-C, indicating an alcohol use disorder","45 Years",{"count":54,"type":22},[106],"PHASE1","The pilot factorial trial will (1) evaluate feasibility, acceptability, and fidelity of the intervention components (Aim 2.1), and (2) collect proof-of-concept data on the impact of the components on the proximal (motivation, self-efficacy, and self-regulation) and distal (quantity and frequency of HED) outcomes (Aim 2.2). Participants will include 120 postpartum mothers recruited from social media. The investigators will conduct a pilot 2X2X2 balanced full factorial trial, with 4 factors (1 constant, 3 randomized to 2 levels each) and 8 study conditions. The 4 factors will include: (1) Standard Helpline (constant); (2) Motivational Interviewing (yes vs. no); (3) Coping skills training (yes vs. no); (4) Automated messaging (yes vs. no). Participants will be randomly assigned to one of 8 study conditions, which will determine which combination of intervention components participants receive.",[109],"Heavy Drinking","2025-01-14",{"date":112,"type":34},"2025-01-15",{"date":114,"type":22},"2025-12-01",{"date":116,"type":22},"2027-07-31",{"name":40,"class":41},""]