Family-Based Protocol for Medication Integration in Treatment of Comorbid ASU/ADHD in Routine Care
Primary Purpose
Adolescent Substance Abuse, Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Medication integration protocol
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Substance Abuse focused on measuring Co-occurring adolescent substance use and ADHD
Eligibility 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
Sites / Locations
- Roberto Clemente Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Medication Integration Protocol
Arm Description
Outcomes
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01539941
First Posted
February 15, 2012
Last Updated
August 3, 2015
Sponsor
The National Center on Addiction and Substance Abuse at Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT01539941
Brief Title
Family-Based Protocol for Medication Integration in Treatment of Comorbid ASU/ADHD in Routine Care
Official Title
Family-Based Protocol for Medication Integration in Treatment of Comorbid ASU/ADHD in Routine Care
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The National Center on Addiction and Substance Abuse at Columbia University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Substance Abuse, Attention Deficit Hyperactivity Disorder
Keywords
Co-occurring adolescent substance use and ADHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medication Integration Protocol
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Medication integration protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication Integration Protocol Feasibility, as assessed by qualitative interviewing of psychiatrist and therapists and also though qualitative interviews administered to teen and caregiver participants
Description
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.
Time Frame
Ongoing; 3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron T Hogue, PhD
Organizational Affiliation
The Natl Cntr on Addiction and Substance Abuse at Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roberto Clemente Center
City
New York
State/Province
New York
ZIP/Postal Code
10009
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Family-Based Protocol for Medication Integration in Treatment of Comorbid ASU/ADHD in Routine Care
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