Integrated Treatment of Marijuana Abuse for HIV+ Youth

This study has been completed.

Sponsor:

Collaborators:

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

ClinicalTrials.gov Identifier:

NCT00683488

First received: May 21, 2008

Last updated: December 14, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 21, 2008

Last Updated Date

December 14, 2012

Start Date ^ICMJE

April 2008

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00683488 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Integrated Treatment of Marijuana Abuse for HIV+ Youth

Official Title ^ICMJE

Integrated Treatment of Alcohol and/or Marijuana Abuse for HIV-Infected Youth - Phase I

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Behavioral: Focus Group
Focus group using and collecting feedback on the CBT/CM intervention.
Behavioral: First Intervention Trial
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.
Behavioral: Intervention Trial 2
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.

Study Arm (s)

Experimental: 1
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.

Intervention: Behavioral: Focus Group
Experimental: 2
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.

Intervention: Behavioral: First Intervention Trial
Experimental: 3
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: Behavioral: Intervention Trial 2

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2011

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years to 24 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00683488

Other Study ID Numbers ^ICMJE

ATN 069

Has Data Monitoring Committee

Yes

Responsible Party

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Sponsor ^ICMJE

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborators ^ICMJE

National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)

Investigators ^ICMJE

Study Chair:

Larry K. Brown, M.D.

Adolescent Trials Network

Information Provided By

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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