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

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ClinicalTrials.gov Identifier: NCT01369459
Recruitment Status : Completed
First Posted : June 9, 2011
Last Update Posted : August 5, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Attention Deficit Disorder Behavioral: MIP Protocol Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Family-Based Protocol for Medication Integration in Treatment of Comorbid ASU/ADHD
Study Start Date : November 2011
Primary Completion Date : March 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Mini International Neuropsychiatric Interview (MINI) Version 5.0 [ Time Frame: 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 :
  1. Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01369459


Locations
United States, New York
Roberto Clemente Center
New York, New York, United States, 10009
Sponsors and Collaborators
The National Center on Addiction and Substance Abuse at Columbia University
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
More Information

Additional Information:
Responsible Party: Aaron Hogue, Director of Adolescent & Family Research, The National Center on Addiction and Substance Abuse at Columbia University
ClinicalTrials.gov Identifier: NCT01369459     History of Changes
Other Study ID Numbers: CASA2011MIP
1R21DA031305-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 9, 2011    Key Record Dates
Last Update Posted: August 5, 2015
Last Verified: August 2015

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

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms