Family Support Protocol for Depression and Substance Use Disorder

(Fam-AID Trial)

Recruiting at 3 trial locations

Overseen By Nicole P Porter, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The National Center on Addiction and Substance Abuse at Columbia University

Disqualifiers: Hospitalization, Psychotic symptoms, Severe SU, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Ongoing during Years 2-3

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to enhance support for adolescents dealing with both substance use and internalizing disorders such as depression and anxiety. It tests a new treatment approach called Fam-AID (Family Support Protocol for Adolescent Internalizing Disorders), which combines family support with proven psychological techniques to improve treatment outcomes. This trial suits teens aged 13-21 who live with a caregiver willing to join therapy sessions and have symptoms of both substance use issues and conditions like depression or anxiety. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could shape future treatment strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this protocol is safe for adolescents with depression and substance use disorder?

Research has shown that the Family Support Protocol for Adolescent Internalizing Disorders (Fam-AID) builds on treatments with strong evidence backing them. This means that components of Fam-AID, such as family involvement and cognitive-behavioral therapy (CBT), are known to be safe and effective for treating depression and anxiety in young people. CBT, for instance, is a common therapy that helps individuals change their thinking and behavior patterns.

Fam-AID aims to help families support teenagers dealing with both substance use and emotional issues like depression. The approach is flexible, allowing adjustments to meet different needs, which makes it easier for therapists to apply in real-life situations. The treatment focuses on keeping teenagers safe and improving their mental health without requiring significant changes to their current care for substance use problems.

While specific data on the safety of Fam-AID itself is not yet available, its components have been studied and are generally considered safe for young people. As testing continues, more information will become available. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Fam-AID protocol because it shifts the focus from traditional individual therapy for depression and substance use disorder to a family-centered approach. Unlike standard treatments, which often rely on medication or one-on-one therapy sessions, Fam-AID involves family members directly in the healing process, aiming to create a supportive home environment that can enhance the adolescent's mental health outcomes. This novel approach could lead to more sustainable recovery by addressing the interpersonal dynamics that often contribute to these disorders.

What evidence suggests that the Family Support Protocol is effective for treating adolescent depression and substance use disorder?

Research has shown that involving family in treatment can improve outcomes for teenagers facing substance use issues and mental health problems such as depression and anxiety. Family involvement enhances the effectiveness of treatments for these conditions. In this trial, participants will receive the Fam-AID program, which incorporates methods like cognitive-behavioral therapy (CBT) and family participation, both well-supported by previous research. CBT helps manage negative feelings and actions, while family participation ensures caregiver involvement in the recovery process. These elements aim to support teens by creating a stronger support system and focusing on practical, real-life solutions. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adolescents aged 13-18 with substance use disorder and internalizing disorders like depression or anxiety. They must live with a caregiver who can attend treatment sessions, meet criteria for outpatient substance use treatment, and have symptoms of specific mental health conditions.

Inclusion Criteria

I am between 13 and 18 years old.

I live with a caregiver who can come to treatment sessions with me.

I have symptoms of substance use disorder and qualify for outpatient treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Phase

Development of Fam-AID implementation toolkit, including provider input, video-based training, and pilot testing with 4-6 clients

Part of Year 1

Multiple visits for training and pilot testing

Treatment

Implementation of Fam-AID protocol with five treatment modules targeting internalizing disorders among adolescents with SUD

Ongoing during Years 2-3

Regular sessions as per treatment protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on internalizing disorder symptoms and family involvement

6 months

Follow-up assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Family Support Protocol for Adolescent Internalizing Disorders (Fam-AID)

Trial Overview

The Fam-AID protocol is being tested to see if it helps teens with drug addiction and depression/anxiety by involving their families in treatment. It includes modules on family engagement, relational reframing, functional analysis of symptoms, cognitive-behavioral therapy techniques, and safety planning.

How Is the Trial Designed?

Group I: Fam-Aid Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The National Center on Addiction and Substance Abuse at Columbia University

Lead Sponsor

Trials

13

Recruited

3,500+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11443177/

Family Support Protocol for Adolescent Internalizing Disorders

This pilot treatment development study aims to develop and test a modular treatment protocol for addressing cooccurring IDs among adolescents.

2.

researchprotocols.org

researchprotocols.org/2024/1/e64332

Family Support Protocol for Adolescent Internalizing ...

National and community surveys report that adolescents with substance use disorders (SUDs) have comorbidity rates ranging between 17% and 30% ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06413979

Family Support Protocol for Adolescent Internalizing ...

This R34 will develop and test an adjunctive treatment protocol for addressing co-occurring internalizing disorders among adolescents enrolled in usual care ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39284179/

Family Support Protocol for Adolescent Internalizing Disorders

Objective: This pilot treatment development study aims to develop and test a modular treatment protocol for addressing cooccurring IDs among ...

5.

researchgate.net

researchgate.net/publication/382438629_Family_Support_Protocol_for_Adolescent_Internalizing_Disorders_Fam-AID_Study_Protocol_for_a_Quasi-Experimental_Treatment_Development_Study_Preprint

(PDF) Family Support Protocol for Adolescent Internalizing ...

PDF | Background Internalizing disorders (IDs), primarily depression and anxiety, are highly prevalent among adolescents receiving community-based.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06413979

Family Support Protocol for Adolescent Internalizing Disorders

This R34 will develop and test an adjunctive treatment protocol for addressing co-occurring internalizing disorders among adolescents enrolled in usual care ...