Clinical trial NCT00683488: Integrated Treatment of Marijuana Abuse for HIV+ Youth
Official title: Integrated Treatment of Alcohol and/or Marijuana Abuse for HIV-Infected Youth - Phase I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: 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
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
First posted: 2008-05-23
Enrollment: 46
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Childrens Hospital of Los Angeles
state: California
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Philadelphia
country: United States
facility: Childrens Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Adolescent Trials Network
name: Larry K. Brown, M.D.
role: STUDY_CHAIR
References: