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

Sponsors and Collaborators:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Drug Abuse (NIDA) National Institute of Mental Health (NIMH)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00683488

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 I

MedlinePlus related topics: AIDS Child Mental Health Marijuana Mental Health

Drug Information available for: Cannabis GW-1000 Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Integrated Treatment of Alcohol and/or Marijuana Abuse for HIV-Infected Youth - Phase I

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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 ]

Estimated Enrollment:	47
Study Start Date:	April 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Experimental 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.
3: Experimental 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
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

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

Contacts

Contact: Sarah Thornton, BS	240-453-5649	sarahthornton@westat.com
Contact: Larry K. Brown, M.D.	401-444-8539	lkbrown@lifespan.org

Locations

United States, California
Childrens Hospital of Los Angeles	Recruiting
Los Angeles, California, United States, 90027
Contact: Diane Tucker, RN, MSN 323-361-3914 dtucker@chla.usc.edu
Contact: Nancy Flores, BA (323) 361-5360 nflores@chla.usc.edu
Principal Investigator: Marvin Belzer, MD
United States, New York
Mount Sinai Medical Center	Recruiting
New York, New York, United States, 10128
Contact: Mary S Geiger, MPH 212-423-2867 mary.geiger@msnyuhealth.org
Contact: Angela Lee, PA-C, MPH (212) 423-2962 angela.lee@msnyuhealth.org
Principal Investigator: John B Steever, MD
United States, Pennsylvania
Childrens Hospital of Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary Tanney, RN, MSN, MPH, CRNP (215) 590-4954 tanney@email.chop.edu
Contact: Annette Hockenberry, BSN 215-590-0682 hockenberrya@email.chop.edu
Principal Investigator: Bret Rudy, MD

Sponsors and Collaborators

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

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

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

Responsible Party:	Adolescent Trials Network ( Larry K. Brown, M.D. )
Study ID Numbers:	ATN 069
Study First Received:	May 21, 2008
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00683488
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Disorders of Environmental Origin
Marijuana Abuse
Immunologic Deficiency Syndromes
Virus Diseases
HIV Seropositivity

HIV Infections
Mental Disorders
Sexually Transmitted Diseases
Substance-Related Disorders
Retroviridae Infections
Ethanol

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009