Medication Integration in Treatment of Comorbid Adolescent Substance Users/Attention Deficit Hyperactivity Disorder (MIP)
This study is not yet open for participant recruitment.
Verified February 2012 by The National Center on Addiction and Substance Abuse at Columbia University
Sponsor:
The National Center on Addiction and Substance Abuse at Columbia University
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
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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
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 May 19, 2013