Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413979
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-02
Brief Title:
Family Support Protocol for Adolescent Internalizing Disorders
Sponsor:
The National Center on Addiction and Substance Abuse at Columbia University
Organization:
The National Center on Addiction and Substance Abuse at Columbia University
Study Overview
Official Title:
Testing the Feasibility of a Family-based Adjunctive Treatment Protocol for Targeting Co-Occurring Internalizing Disorders Among Adolescents With SUD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Fam-AID
Brief 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 SUDID 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 youths ID symptoms 3 Functional Analysis of the youths ID symptoms and related behaviors 4 Cognitive-behavioral therapy CBT core techniques to address the youths 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 SUDID 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 PIs existing online therapist training and consultation resources in core CBT techniques for adolescent SUD as well as the Co-Is 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 SUDID 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
A promising solution to diminish this quality gap is developing an adjunctive modular protocol to augment routine care for comorbid SUDID 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 youths ID symptoms 3 Functional Analysis of the youths ID symptoms and related behaviors 4 Cognitive-behavioral therapy CBT core techniques to address the youths 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 SUDID 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 PIs existing online therapist training and consultation resources in core CBT techniques for adolescent SUD as well as the Co-Is 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 SUDID 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None