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

NCT01539941 | Completed Phase 1 DMC

• 1 other identifier: R21DA031305-01A1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Substance Abuse; Attention Deficit Hyperactivity Disorder

Keywords

Co-occurring adolescent substance use and ADHD

Outcome Measures

Primary Outcomes (1)

• Medication Integration Protocol Feasibility, as assessed by qualitative interviewing of psychiatrist and therapists and also though qualitative interviews administered to teen and caregiver participants

  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.

  Ongoing; 3-month follow-up

Study Arms (1)

Medication Integration Protocol

EXPERIMENTAL

Behavioral: Medication integration protocol

Interventions

Medication integration protocol BEHAVIORAL

MIP is a 5 session protocol. The first session consists of pretreatment assessment activities using measures administered during routine clinical intake. The following sessions, MIP Sessions 1-4, are meant to be delivered sequentially, commencing sometime after session 2 or 3 of treatment, that is, after completion of initial treatment contracting and engagement interventions that will usually be focused on ASU-related referral problems for this population. The proposed pilot work will shed light on the optimal timing for MIP Sessions 1-4.

Medication Integration Protocol

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Roberto Clemente Center

New York, New York, 10009, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Aaron T Hogue, PhD

  The Natl Cntr on Addiction and Substance Abuse at Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: February 28, 2012
• Study Start: August 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 4, 2015

Record last verified: 2012-02

Locations

US (1)