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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by The National Center on Addiction and Substance Abuse at Columbia University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
The National Center on Addiction and Substance Abuse at Columbia University
ClinicalTrials.gov Identifier:
NCT01369459
First received: June 7, 2011
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Attention Deficit Disorder
Behavioral: MIP Protocol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Family-Based Protocol for Medication Integration in Treatment of Comorbid ASU/ADHD

Resource links provided by NLM:


Further study details as provided by The National Center on Addiction and Substance Abuse at Columbia University:

Primary Outcome Measures:
  • Mini International Neuropsychiatric Interview (MINI) Version 5.0 [ Time Frame: Follow-up in 3 months ] [ Designated as safety issue: No ]
    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:
  • Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: Follow-up at 3-months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369459

Contacts
Contact: Aaron T Hogue, Ph.D. 212-841-5278 athogue@aol.com
Contact: Sam R Jackson, B.A. 212-841-5257 sjackson@casacolumbia.org

Locations
United States, New York
Roberto Clemente Center Not yet recruiting
New York, New York, United States, 10009
Sub-Investigator: Aaron T Hogue, Ph.D.         
Sponsors and Collaborators
The National Center on Addiction and Substance Abuse at Columbia University
Investigators
Principal Investigator: Aaron T Hogue, Ph.D. The National Center on Addiction and Substance Abuse at Columbia University
  More Information

Additional Information:
No publications provided

Responsible Party: Aaron Hogue, Ph. D.; Associate Director, Health and Treatment Research and Analysis Division, The National Center on Addiction and Substance Abuse at Columbia University
ClinicalTrials.gov Identifier: NCT01369459     History of Changes
Other Study ID Numbers: CASA2011MIP, 1 R21 DA031305-01A1
Study First Received: June 7, 2011
Last Updated: February 15, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by The National Center on Addiction and Substance Abuse at Columbia University:
Comorbid
ADHD
SUD
ASU

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014