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Integrated Treatment of Marijuana Abuse for HIV+ Youth

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Focus Group
First Intervention Trial
Intervention Trial 2
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Substance Abuse, Adolescent community reinforcement approach, Adolescent Risk Behavior Assessment, Child and Adolescent Services Assessment, Cognitive behavioral therapy, Cognitive Therapy Rating Scale, Individual behavior therapy, Individual cognitive problem solving, Motivational enhancement therapy, HIV-Positive Youth With Substance Abuse, Complementary Therapies

Eligibility Criteria

16 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adolescents between the ages of 16-24 years (inclusive) at the time of informed consent/assent as determined by medical record review or verbal verification from referring professional
  • HIV-infected and aware of their status as documented by medical record review or verbal verification from referring professional
  • Receives services at one of the three participating ATN clinic site or their community partners
  • A score of 2 or greater on the CRAFFT indicating possible alcohol or marijuana use problem or abuse
  • Alcohol and/or Marijuana Use or Abuse Disorder as indicated by the SSPQ-X
  • Appropriate for an outpatient or intensive outpatient level of care in accordance with the American Academy of Child and Adolescent Psychiatry practice parameters as decided by site mental health provider in consultation with Drs. Brown and Esposito-Smythers
  • English-speaking
  • Ability and willingness to provide informed consent/assent for study participation
  • Satisfactorily understands the nature of the study and the informed consent process as documented by the Consent Form Comprehension Assessment Questionnaire

Exclusion Criteria:

  • Presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder)
  • Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior)
  • Intoxicated or under the influence of alcohol or other substances at the time of study entry

Sites / Locations

  • Childrens Hospital of Los Angeles
  • Mount Sinai Medical Center
  • Childrens Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Focus groups with adolescents with SA (Substance Abuse) will be conducted at each site (one group with 5 to 6 adolescents per site) to provide information on the areas of the intervention in need of adaptation in order to reflect the context of HIV infection.

The first intervention trial will enroll 9 participants (3 participants per site). Exit interviews of participants will assess acceptability, feasibility, and relevance of the intervention. Quantitative assessments pre and post intervention using audio computer-assisted self-interviewing (ACASI) will document immediate changes in substance use, sexual risk, and adherence to medical care. Additional qualitative feedback from interviews with mental health providers and study coordinators will address feasibility, acceptability, and relevance of the intervention and its methods.

The revised intervention will be implemented with 20 participants (6 to 8 at each site). Exit interviews with subjects and feedback from mental health providers and study coordinators will provide the same qualitative information as in the first intervention trial. Quantitative data on participant outcomes such as substance use, sexual risk, and adherence to medical care will be collected pre, post and 3 month post intervention through ACASI.

Outcomes

Primary Outcome Measures

To adapt a developmentally appropriate CBT/CM intervention for alcohol and/or marijuana abuse for HIV+ youth, relevant to the context of chronic medical care, emotion dysregulation due to frequent co-morbid psychiatric disorders and sexual risk behavior.
To evaluate the acceptability, feasibility, and effectiveness of the CBT/CM intervention for alcohol and/or marijuana abuse, adherence to medical care, emotion regulation, and safer sexual behavior.

Secondary Outcome Measures

To revise the CBT/CM intervention based on information obtained in Phase 1 (this protocol), prepare for Phase 2 (to be supported by NIH), and disseminate the treatment manual to the ATN sites.

Full Information

First Posted
May 21, 2008
Last Updated
March 2, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00683488
Brief Title
Integrated Treatment of Marijuana Abuse for HIV+ Youth
Official Title
Integrated Treatment of Alcohol and/or Marijuana Abuse for HIV-Infected Youth - Phase I
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an exploratory study that will adapt and test a combined cognitive behavioral treatment and contingency management intervention for alcohol and/or marijuana abuse for use in HIV-infected adolescents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Substance Abuse, Adolescent community reinforcement approach, Adolescent Risk Behavior Assessment, Child and Adolescent Services Assessment, Cognitive behavioral therapy, Cognitive Therapy Rating Scale, Individual behavior therapy, Individual cognitive problem solving, Motivational enhancement therapy, HIV-Positive Youth With Substance Abuse, Complementary Therapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Focus groups with adolescents with SA (Substance Abuse) will be conducted at each site (one group with 5 to 6 adolescents per site) to provide information on the areas of the intervention in need of adaptation in order to reflect the context of HIV infection.
Arm Title
2
Arm Type
Experimental
Arm Description
The first intervention trial will enroll 9 participants (3 participants per site). Exit interviews of participants will assess acceptability, feasibility, and relevance of the intervention. Quantitative assessments pre and post intervention using audio computer-assisted self-interviewing (ACASI) will document immediate changes in substance use, sexual risk, and adherence to medical care. Additional qualitative feedback from interviews with mental health providers and study coordinators will address feasibility, acceptability, and relevance of the intervention and its methods.
Arm Title
3
Arm Type
Experimental
Arm Description
The revised intervention will be implemented with 20 participants (6 to 8 at each site). Exit interviews with subjects and feedback from mental health providers and study coordinators will provide the same qualitative information as in the first intervention trial. Quantitative data on participant outcomes such as substance use, sexual risk, and adherence to medical care will be collected pre, post and 3 month post intervention through ACASI.
Intervention Type
Behavioral
Intervention Name(s)
Focus Group
Intervention Description
Focus group using and collecting feedback on the CBT/CM intervention.
Intervention Type
Behavioral
Intervention Name(s)
First Intervention Trial
Intervention Description
Intervention will comprise of approximately 15 weekly sessions. Exit interviews at the end of each session will assess acceptability, feasibility, and relevance of the intervention. Quantitative assessment (ACASI) pre and post intervention will document immediate changes in substance use, sexual risk, and adherence to medical care. Qualitative feedback from interviews with mental health providers and study coordinators will address acceptability and feasibility.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Trial 2
Intervention Description
Evaluations/assessments will be similar to those involved for the first intervention trial. Study participants will return for a follow-up visit 3 months after the last intervention session to complete the ACASI.
Primary Outcome Measure Information:
Title
To adapt a developmentally appropriate CBT/CM intervention for alcohol and/or marijuana abuse for HIV+ youth, relevant to the context of chronic medical care, emotion dysregulation due to frequent co-morbid psychiatric disorders and sexual risk behavior.
Time Frame
2 years
Title
To evaluate the acceptability, feasibility, and effectiveness of the CBT/CM intervention for alcohol and/or marijuana abuse, adherence to medical care, emotion regulation, and safer sexual behavior.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To revise the CBT/CM intervention based on information obtained in Phase 1 (this protocol), prepare for Phase 2 (to be supported by NIH), and disseminate the treatment manual to the ATN sites.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adolescents between the ages of 16-24 years (inclusive) at the time of informed consent/assent as determined by medical record review or verbal verification from referring professional HIV-infected and aware of their status as documented by medical record review or verbal verification from referring professional Receives services at one of the three participating ATN clinic site or their community partners A score of 2 or greater on the CRAFFT indicating possible alcohol or marijuana use problem or abuse Alcohol and/or Marijuana Use or Abuse Disorder as indicated by the SSPQ-X Appropriate for an outpatient or intensive outpatient level of care in accordance with the American Academy of Child and Adolescent Psychiatry practice parameters as decided by site mental health provider in consultation with Drs. Brown and Esposito-Smythers English-speaking Ability and willingness to provide informed consent/assent for study participation Satisfactorily understands the nature of the study and the informed consent process as documented by the Consent Form Comprehension Assessment Questionnaire Exclusion Criteria: Presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder) Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior) Intoxicated or under the influence of alcohol or other substances at the time of study entry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry K. Brown, M.D.
Organizational Affiliation
Adolescent Trials Network
Official's Role
Study Chair
Facility Information:
Facility Name
Childrens Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Childrens Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Integrated Treatment of Marijuana Abuse for HIV+ Youth

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