Back to resultsMedication Integration in Treatment of Comorbid Adolescent Substance Users/Attention Deficit Hyperactivity Disorder (MIP)
Primary Purpose
Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MIP Protocol
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Comorbid, ADHD, SUD, ASU
Eligibility 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
Sites / Locations
- Roberto Clemente Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Family Counseling with MIP Protocol
Historical Control
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01369459
First Posted
June 7, 2011
Last Updated
August 3, 2015
Sponsor
The National Center on Addiction and Substance Abuse at Columbia University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01369459
Brief Title
Medication Integration in Treatment of Comorbid Adolescent Substance Users/Attention Deficit Hyperactivity Disorder
Acronym
MIP
Official Title
Family-Based Protocol for Medication Integration in Treatment of Comorbid ASU/ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The National Center on Addiction and Substance Abuse at Columbia University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder
Keywords
Comorbid, ADHD, SUD, ASU
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Family Counseling with MIP Protocol
Arm Type
Experimental
Arm Description
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.
Arm Title
Historical Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
MIP Protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mini International Neuropsychiatric Interview (MINI) Version 5.0
Description
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.
Time Frame
Follow-up in 3 months
Secondary Outcome Measure Information:
Title
Behavior Rating Inventory of Executive Function (BRIEF)
Description
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.
Time Frame
Follow-up at 3-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron T Hogue, Ph.D.
Organizational Affiliation
The National Center on Addiction and Substance Abuse at Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roberto Clemente Center
City
New York
State/Province
New York
ZIP/Postal Code
10009
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Medication Integration in Treatment of Comorbid Adolescent Substance Users/Attention Deficit Hyperactivity Disorder
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