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

Attention Deficit Hyperactivity Disorder Clinical Trial

— MIP  

Official title:

Family-Based Protocol for Medication Integration in Treatment of Comorbid ASU/ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369459
• Other study ID #: CASA2011MIP
• Secondary ID: 1R21DA031305-01A
• Status: Completed
• Phase: Phase 1
• First received: June 7, 2011
• Last updated: August 3, 2015
• Start date: November 2011
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: The National Center on Addiction and Substance Abuse at Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Disease
• Hyperkinesis

Intervention

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.

Locations

Country	Name	City	State
United States	Roberto Clemente Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
The National Center on Addiction and Substance Abuse at Columbia University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Follow-up in 3 months	No
Secondary	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.	Follow-up at 3-months	No

External Links

•   Website for The National Center on Addiction and Substance Abuse at Columbia University