Trial record 6 of 133 for:
marijuana | Closed Studies | United States
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: December 14, 2012
Last verified: October 2012
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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.
|
|
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: | December 14, 2012 |
| 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:
|
Marijuana Abuse HIV Infections Acquired Immunodeficiency Syndrome 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 May 16, 2013