Integrated Treatment of Marijuana Abuse for HIV+ Youth

This study has been completed.
Sponsor:
Collaborators:
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: October 8, 2013
Last verified: August 2013
  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:


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 ]

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
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

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

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00683488     History of Changes
Other Study ID Numbers: ATN 069
Study First Received: May 21, 2008
Last Updated: October 8, 2013
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Marijuana Abuse
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014