Integrated Treatment of Marijuana Abuse for HIV+ Youth - Full Text View

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Behavioral: Focus Group Behavioral: First Intervention Trial Behavioral: Intervention Trial 2	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Integrated Treatment of Alcohol and/or Marijuana Abuse for HIV-Infected Youth - Phase I

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Marijuana

U.S. FDA Resources

Further study details as provided by Westat:

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. [ 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 ]

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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]


Enrollment:	46
Study Start Date:	April 2008
Study Completion Date:	April 2011
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Behavioral: Focus Group Focus group using and collecting feedback on the CBT/CM intervention.
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.	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.
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.	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.

Eligibility


Ages Eligible for Study:	16 Years to 24 Years (Child, Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683488

Locations


United States, California
Childrens Hospital of Los Angeles
Los Angeles, California, United States, 90027
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10128
United States, Pennsylvania
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Westat

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

Investigators


Study Chair:	Larry K. Brown, M.D.	Adolescent Trials Network

More Information

Additional Information:

Website for the Adolescent Trials Network for HIV/AIDS Interventions This link exits the ClinicalTrials.gov site


Responsible Party:	Westat
ClinicalTrials.gov Identifier:	NCT00683488 History of Changes
Other Study ID Numbers:	ATN 069
Study First Received:	May 21, 2008
Last Updated:	February 29, 2016
Health Authority:	United States: Federal Government

Keywords provided by Westat:


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

Additional relevant MeSH terms:


HIV Infections Marijuana Abuse Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral	Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Substance-Related Disorders Chemically-Induced Disorders Mental Disorders

ClinicalTrials.gov processed this record on September 27, 2016