Medication Integration in Treatment of Comorbid Adolescent Substance Users/Attention Deficit Hyperactivity Disorder

Phase 1

Completed

• Conditions: Attention Deficit Disorder; Attention Deficit Hyperactivity Disorder
• Interventions: Behavioral: MIP Protocol

• Registration Number: NCT01369459
• Lead Sponsor: The National Center on Addiction and Substance Abuse at Columbia University

Brief Summary

The goal of this project is to develop and test a brief protocol designed to systematically integrate pharmacological interventions for Attention Deficit Hyperactivity Disorder (ADHD) into behavioral treatment services for adolescent substance users with co-morbid ADHD in everyday care. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-07
• Study First Submitted QC: 2011-06-08
• Study First Posted: 2011-06-09
• Study Start: 2011-11
• Primary Completion: 2014-03
• Study Completion: 2014-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-03
• Last Update Posted: 2015-08-05

Recruitment & Eligibility

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

Inclusion Criteria

• Age 13-17 years
• 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
• currently suicidal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Family Counseling with MIP Protocol	MIP Protocol	We intend for MIP to be a 5-session, family-based protocol delivered during the early portion of ASU treatment. MIP will contain three elements deemed essential for integrating pharmacological interventions into outpatient behavioral treatment for youth: (1) standardized psychiatric assessment and family-focused psychoeducation about the target problem; (2) an approved medication regimen with demonstrated efficacy for comorbid populations; (3) family-based interventions for medication acceptance and coordination of psychiatric and behavioral services. MIP will incorporate research-proven interventions from each of these core areas.

Primary Outcome Measures

Name	Time	Method
Mini International Neuropsychiatric Interview (MINI) Version 5.0	Follow-up in 3 months	MINI is a structured diagnostic interview that assesses DSM-IV diagnoses in adolescents and is designed for administration by lay interviewers. Adolescents and caregivers will complete the Inattentive and Hyperactive/Impulsive scales.

Secondary Outcome Measures

Name	Time	Method
Behavior Rating Inventory of Executive Function (BRIEF)	Follow-up at 3-months	The BRIEF is a parent-report measure of behavioral problems linked to executive functioning and commonly observed in ADHD youth. The BRIEF has been validated on ADHD outpatient samples and teens with mixed clinical diagnoses. This study will use 4 scales: Inhibition, Behavioral Shift, Emotional Control, Plan/Organize.

Trial Locations

Locations (1)

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