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OpenTrials
Completed

NCT Number: NCT01369459

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

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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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Roberto Clemente Center

New York, 10009, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MIP Protocol

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The National Center on Addiction and Substance Abuse at Columbia University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: MIP

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 9, 2011
Registry last updated
Aug 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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