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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Aaron Hogue, The National Center on Addiction and Substance Abuse at Columbia University
ClinicalTrials.gov Identifier:
NCT01369459
First received: June 7, 2011
Last updated: August 3, 2015
Last verified: August 2015

June 7, 2011
August 3, 2015
November 2011
March 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01369459 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Medication Integration in Treatment of Comorbid Adolescent Substance Users/Attention Deficit Hyperactivity Disorder
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Attention Deficit Hyperactivity Disorder
  • Attention Deficit Disorder
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.
  • 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.
    Intervention: Behavioral: MIP Protocol
  • No Intervention: Historical Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
December 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
13 Years to 17 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01369459
CASA2011MIP, 1R21DA031305-01A1
Yes
Not Provided
Not Provided
Aaron Hogue, The National Center on Addiction and Substance Abuse at Columbia University
The National Center on Addiction and Substance Abuse at Columbia University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Aaron T Hogue, Ph.D. The National Center on Addiction and Substance Abuse at Columbia University
The National Center on Addiction and Substance Abuse at Columbia University
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP