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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01539941
First Posted: February 28, 2012
Last Update Posted: August 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The National Center on Addiction and Substance Abuse at Columbia University
  Purpose
The goal of this proposal is to develop and pilot a brief protocol designed to systematically integrate pharmacological interventions for attention deficit hyperactivity disorder (ADHD) into behavioral treatment services for adolescent substance users with comorbid ADHD in everyday care. ADHD is a prevalent co-occurring condition for adolescent substance use (ASU) that can significantly impede successful ASU treatment but is vastly under-diagnosed and undertreated among ASU clients in agency settings. Moreover, ADHD medication acceptance and compliance is particularly difficult to achieve in high-risk adolescent populations.

Condition Intervention Phase
Adolescent Substance Abuse Attention Deficit Hyperactivity Disorder Behavioral: Medication integration protocol Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Family-Based Protocol for Medication Integration in Treatment of Comorbid ASU/ADHD in Routine Care

Further study details as provided by The National Center on Addiction and Substance Abuse at Columbia University:

Primary Outcome Measures:
  • Medication Integration Protocol Feasibility, as assessed by qualitative interviewing of psychiatrist and therapists and also though qualitative interviews administered to teen and caregiver participants [ Time Frame: Ongoing; 3-month follow-up ]
    Brief qualitative interviews will be designed and administered to the on-site psychiatrist and family therapists to capture judgments about the viability and acceptability of MIP compared to previous site practices, as well as its perceived short- and long-term safety and effectiveness for ASU/ADHD cases. A parallel qualitative interview will be administered to teens and caregivers at 3-month follow-up. MIP teens will also receive incentives to maintain medication diaries of daily pill intake, using the NIDA CTN method.


Enrollment: 14
Study Start Date: August 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medication Integration Protocol Behavioral: Medication integration protocol
MIP is a 5 session protocol. The first session consists of pretreatment assessment activities using measures administered during routine clinical intake. The following sessions, MIP Sessions 1-4, are meant to be delivered sequentially, commencing sometime after session 2 or 3 of treatment, that is, after completion of initial treatment contracting and engagement interventions that will usually be focused on ASU-related referral problems for this population. The proposed pilot work will shed light on the optimal timing for MIP Sessions 1-4.

Detailed Description:
The goal of this proposal is to develop and pilot a brief protocol designed to systematically integrate pharmacological interventions for attention deficit hyperactivity disorder (ADHD) into behavioral treatment services for adolescent substance users with comorbid ADHD in everyday care. ADHD is a prevalent co-occurring condition for adolescent substance use (ASU) that can significantly impede successful ASU treatment but is vastly under-diagnosed and undertreated among ASU clients in agency settings. Moreover, ADHD medication acceptance and compliance is particularly difficult to achieve in high-risk adolescent populations. The proposed R21 study will use an interrupted time series design to test a brief protocol designed to promote integration of evidence-based ADHD pharmacotherapy into routine behavioral services for ASU: Medication Integration Protocol (MIP). MIP is a 5-session family-based protocol delivered during the early portion of ASU treatment that contains three research-based elements: (1) standardized psychiatric assessment and family-focused psychoeducation about adolescent ADHD; (2) an approved ADHD medication regimen (OROS-MPH) with demonstrated efficacy for ASU/ADHD clients; (3) family-based interventions to support medication acceptance (as indicated) and coordination of care between psychiatric and behavioral services. MIP will be integrated into existing family-based services at one partnering clinical site: 20 ASU/ADHD cases will be treated by site family therapists who will be newly trained and monitored in MIP. The partnering clinic provides family therapy as the routine standard of care for outpatient behavioral health and offers on-site child psychiatry services. 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. Exploratory analyses will generate effect sizes for the short-term impact of MIP on the main targets of ADHD medication: ADHD symptoms and executive cognitive functioning. New study products would include a standardized and piloted MIP protocol, clinician training and fidelity monitoring procedures, and an observational fidelity instrument. If validated, MIP could be utilized as a stand-alone intervention in everyday care, or, be combined with existing manualized treatments for ASU in an effort to develop fully integrated treatment models for ASU/ADHD. Also, MIP could be delivered in conjunction with either family-based treatments or individual treatments that can flexibly include caregivers in early sessions.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 13-17, (2) 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
  • current suicidality
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539941


Locations
United States, New York
Roberto Clemente Center
New York, New York, United States, 10009
Sponsors and Collaborators
The National Center on Addiction and Substance Abuse at Columbia University
Investigators
Principal Investigator: Aaron T Hogue, PhD The Natl Cntr on Addiction and Substance Abuse at Columbia University
  More Information

Responsible Party: The National Center on Addiction and Substance Abuse at Columbia University
ClinicalTrials.gov Identifier: NCT01539941     History of Changes
Other Study ID Numbers: R21DA031305-01A1 ( U.S. NIH Grant/Contract )
First Submitted: February 15, 2012
First Posted: February 28, 2012
Last Update Posted: August 4, 2015
Last Verified: February 2012

Keywords provided by The National Center on Addiction and Substance Abuse at Columbia University:
Co-occurring adolescent substance use and ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Substance-Related Disorders
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Chemically-Induced Disorders