Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2008-04-30
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Focus Group
Focus group using and collecting feedback on the CBT/CM intervention.
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.
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.
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 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.
Interventions
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Focus Group
Focus group using and collecting feedback on the CBT/CM intervention.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
24 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
National Institute of Mental Health (NIMH)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Larry K. Brown, M.D.
Role: STUDY_CHAIR
Adolescent Trials Network
Locations
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Childrens Hospital of Los Angeles
Los Angeles, California, United States
Mount Sinai Medical Center
New York, New York, United States
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Related Links
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Website for the Adolescent Trials Network for HIV/AIDS Interventions
Other Identifiers
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ATN 069
Identifier Type: -
Identifier Source: org_study_id
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