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

NCT01369459 | Completed Phase 1 DMC

• 2 other identifiers: CASA2011MIP1R21DA031305-01A1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder; Attention Deficit Disorder

Keywords

Comorbid; ADHD; SUD; ASU

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Behavior Rating Inventory of Executive Function (BRIEF)

  Follow-up at 3-months

Study Arms (2)

Family Counseling with MIP Protocol

EXPERIMENTAL

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

Historical Control

NO INTERVENTION

Interventions

MIP Protocol BEHAVIORAL

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.

Family Counseling with MIP Protocol

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• MDD
• Bipolar Disorder
• Mental Retardation
• PDD
• medical or psychiatric illness requiring hospitalization
• current psychotic features
• currently suicidal

Sponsors & Collaborators

• The National Center on Addiction and Substance Abuse at Columbia University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Roberto Clemente Center

New York, New York, 10009, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

MIP protocol

Condition Hierarchy (Ancestors)

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

Study Officials

• Aaron T Hogue, Ph.D.

  The National Center on Addiction and Substance Abuse at Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Adolescent & Family Research

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: June 9, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 5, 2015

Record last verified: 2015-08

Locations

US (1)