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

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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder; Attention Deficit Disorder
• Intervention / Treatment: Behavioral: MIP Protocol

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10009
      • Roberto Clemente Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Family Counseling with 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.	Behavioral: 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.
NO_INTERVENTION: Historical Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini International Neuropsychiatric Interview (MINI) Version 5.0	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.	Follow-up in 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavior Rating Inventory of Executive Function (BRIEF)	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.	Follow-up at 3-months

Collaborators and Investigators

• Sponsor: The National Center on Addiction and Substance Abuse at Columbia University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Aaron T Hogue, Ph.D., The National Center on Addiction and Substance Abuse at Columbia University

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: June 7, 2011
• First Submitted That Met QC Criteria: June 8, 2011
• First Posted (ESTIMATE): June 9, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 5, 2015
• Last Update Submitted That Met QC Criteria: August 3, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: ADHD; SUD; Comorbid; ASU
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: CASA2011MIP; 1R21DA031305-01A1 (NIH)