Family-Based Protocol for Medication Integration in Treatment of Comorbid ASU/ADHD in Routine Care

Phase 1

Completed

• Conditions: Attention Deficit Hyperactivity Disorder; Adolescent Substance Abuse
• Interventions: Behavioral: Medication integration protocol

• Registration Number: NCT01539941
• Lead Sponsor: The National Center on Addiction and Substance Abuse at Columbia University

Brief Summary

The goal of this proposal is to develop and pilot a brief protocol designed to systematically integrate pharmacological interventions for attention deficit hyperactivity disorder (ADHD) into behavioral treatment services for adolescent substance users with comorbid ADHD in everyday care. ADHD is a prevalent co-occurring condition for adolescent substance use (ASU) that can significantly impede successful ASU treatment but is vastly under-diagnosed and undertreated among ASU clients in agency settings. Moreover, ADHD medication acceptance and compliance is particularly difficult to achieve in high-risk adolescent populations.

Detailed Description

The goal of this proposal is to develop and pilot a brief protocol designed to systematically integrate pharmacological interventions for attention deficit hyperactivity disorder (ADHD) into behavioral treatment services for adolescent substance users with comorbid ADHD in everyday care. ADHD is a prevalent co-occurring condition for adolescent substance use (ASU) that can significantly impede successful ASU treatment but is vastly under-diagnosed and undertreated among ASU clients in agency settings. Moreover, ADHD medication acceptance and compliance is particularly difficult to achieve in high-risk adolescent populations. The proposed R21 study will use an interrupted time series design to test a brief protocol designed to promote integration of evidence-based ADHD pharmacotherapy into routine behavioral services for ASU: Medication Integration Protocol (MIP). MIP is a 5-session family-based protocol delivered during the early portion of ASU treatment that contains three research-based elements: (1) standardized psychiatric assessment and family-focused psychoeducation about adolescent ADHD; (2) an approved ADHD medication regimen (OROS-MPH) with demonstrated efficacy for ASU/ADHD clients; (3) family-based interventions to support medication acceptance (as indicated) and coordination of care between psychiatric and behavioral services. MIP will be integrated into existing family-based services at one partnering clinical site: 20 ASU/ADHD cases will be treated by site family therapists who will be newly trained and monitored in MIP. The partnering clinic provides family therapy as the routine standard of care for outpatient behavioral health and offers on-site child psychiatry services. Primary study aims will yield proof-of-concept data on MIP feasibility and fidelity in usual care and evidence of MIP impact on psychiatric and behavioral services utilization, medication acceptance and compliance, and satisfaction with treatment services. Exploratory analyses will generate effect sizes for the short-term impact of MIP on the main targets of ADHD medication: ADHD symptoms and executive cognitive functioning. New study products would include a standardized and piloted MIP protocol, clinician training and fidelity monitoring procedures, and an observational fidelity instrument. If validated, MIP could be utilized as a stand-alone intervention in everyday care, or, be combined with existing manualized treatments for ASU in an effort to develop fully integrated treatment models for ASU/ADHD. Also, MIP could be delivered in conjunction with either family-based treatments or individual treatments that can flexibly include caregivers in early sessions.

Study Timeline

• Study Start: 2011-08
• Status Verified: 2012-02
• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-02-27
• Study First Posted: 2012-02-28
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2015-08-03
• Last Update Posted: 2015-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• age 13-17, (2) caregiver able to participate in treatment,
• one day of alcohol use to intoxication or illegal drug use in the past 30 days (or 30 days prior to living in a controlled environment),
• endorsement of one or more DSM-IV symptoms of Substance Use or Alcohol Dependence/Abuse,
• meet ASAM criteria for outpatient substance use treatment,
• meet DSM-IV criteria for ADHD (with or without onset prior to age 7),
• not enrolled in any behavioral treatment.

Exclusion Criteria

• MDD
• Bipolar Disorder
• mental retardation
• PDD
• medical or psychiatric illness requiring hospitalization
• current psychotic features
• current suicidality

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Medication Integration Protocol	Medication integration protocol	-

Primary Outcome Measures

Name	Time	Method
Medication Integration Protocol Feasibility, as assessed by qualitative interviewing of psychiatrist and therapists and also though qualitative interviews administered to teen and caregiver participants	Ongoing; 3-month follow-up	Brief qualitative interviews will be designed and administered to the on-site psychiatrist and family therapists to capture judgments about the viability and acceptability of MIP compared to previous site practices, as well as its perceived short- and long-term safety and effectiveness for ASU/ADHD cases. A parallel qualitative interview will be administered to teens and caregivers at 3-month follow-up. MIP teens will also receive incentives to maintain medication diaries of daily pill intake, using the NIDA CTN method.

Trial Locations

Locations (1)

Roberto Clemente Center; 🇺🇸 New York, New York, United States