Family Support Protocol for Adolescent Internalizing Disorders
NCT06413979 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-04-17
Summary
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.
A promising solution to diminish this quality gap is developing an adjunctive, modular protocol to augment routine care for comorbid SUD/ID 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/ID and prevention of youth self-harm. All interventions featured in each module have strong empirical support.
The 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.
To 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/ID 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.
Conditions
- Internalizing Disorders
- Substance Use Disorders
Interventions
- BEHAVIORAL
-
Family Support Protocol for Adolescent Internalizing Disorders (Fam-AID)
(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/ID and prevention of youth self-harm. All interventions featured in each module have strong empirical support.
Sponsors & Collaborators
-
The National Center on Addiction and Substance Abuse at Columbia University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 13 Years
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-29
- Primary Completion
- 2027-01-31
- Completion
- 2027-03-31
Countries
- United States
Study Locations
More Related Trials
-
Family-based and Adolescent Residential Drug Treatment
NCT01737632 ·Status: COMPLETED ·Phase: NA
-
Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD)
NCT01365247 ·Status: COMPLETED ·Phase: NA
-
Prevention of Substance Use in At-Risk Students: A Family-Centered Web Program
NCT03060291 ·Status: COMPLETED ·Phase: NA
-
Suicide Prevention Among Substance Abusing Homeless Youth
NCT02576834 ·Status: COMPLETED ·Phase: NA
-
Behavioral Depression Treatment for African American HIV-infected Substance Users
NCT01351454 ·Status: COMPLETED ·Phase: NA
-
Integrated Treatment for Posttraumatic Stress Disorder and Substance Abuse in Young Adults
NCT02667119 ·Status: COMPLETED ·Phase: NA
-
Family Engagement, Cross-System Linkage to Substance Use Treatment for Juvenile Probationers -- Phase 3
NCT03048552 ·Status: COMPLETED ·Phase: NA
-
Study of a Transdiagnostic, Emotion-focused Group Intervention for Young Adults With Substance Use Disorders
NCT03315208 ·Status: COMPLETED ·Phase: NA
-
Integrative Risk Reduction and Treatment for Teen Substance Use Problems and PTSD
NCT01751035 ·Status: COMPLETED ·Phase: NA
-
A Family Intervention for Adolescent Problem Behavior (AKA Project Alliance 2)
NCT01490307 ·Status: COMPLETED ·Phase: NA
-
Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness
NCT06311838 ·Status: RECRUITING ·Phase: NA
-
Parent SMART (Substance Misuse in Adolescents in Residential Treatment)
NCT05169385 ·Status: RECRUITING ·Phase: NA
-
Substance Use Treatment and Its Role in Supporting Social Cognition
NCT06535919 ·Status: RECRUITING
-
Developing an Intervention to Address Suicide Risk During Substance Use Disorder
NCT01127932 ·Status: COMPLETED ·Phase: NA
-
Substance Use Prevention for Youth With Parents in Recovery
NCT05397691 ·Status: RECRUITING ·Phase: NA
-
Testing a Promising Treatment for Youth Substance Abuse in a Community Setting
NCT02130479 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Substance Use and Sexual Risk Reduction Intervention for Homeless Youth
NCT02188797 ·Status: COMPLETED ·Phase: NA
-
Outpatient Adolescent Treatment for Comorbid Substance Use and Internalizing Disorders
NCT00438685 ·Status: COMPLETED ·Phase: PHASE1
-
Measurement Training and Feedback System: Family-Based Services
NCT03342872 ·Status: COMPLETED ·Phase: NA
-
Improving Delay Discounting to Decrease Harsh Parenting Among Parents Receiving Substance Use Treatment
NCT05229120 ·Status: COMPLETED ·Phase: NA
-
Transitional Treatment of Adolescents in Family Therapy
NCT00680381 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of Treatments for Homeless Youths
NCT01143792 ·Status: COMPLETED ·Phase: PHASE2
-
A Social Network AOD Intervention for Homeless Youth Transitioning to Housing
NCT04637815 ·Status: COMPLETED ·Phase: PHASE1
-
Brief Strategic Family Therapy for Adolescent Drug Abusers
NCT00095303 ·Status: COMPLETED ·Phase: PHASE3
-
Impaired Decision-making in Adolescents
NCT01253993 ·Status: COMPLETED