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
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 7, 2011 | ||||||||
| Last Updated Date | February 15, 2012 | ||||||||
| Start Date ICMJE | November 2011 | ||||||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01369459 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Medication Integration in Treatment of Comorbid Adolescent Substance Users/Attention Deficit Hyperactivity Disorder | ||||||||
| Official Title ICMJE | Family-Based Protocol for Medication Integration in Treatment of Comorbid ASU/ADHD | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 13 Years to 17 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01369459 | ||||||||
| Other Study ID Numbers ICMJE | CASA2011MIP, 1 R21 DA031305-01A1 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| 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 | ||||||||
| Study Sponsor ICMJE | The National Center on Addiction and Substance Abuse at Columbia University | ||||||||
| Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||||||
| Investigators ICMJE |
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| Information Provided By | The National Center on Addiction and Substance Abuse at Columbia University | ||||||||
| Verification Date | February 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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