Integrated Treatment of Marijuana Abuse for HIV+ Youth

NCT00683488 | Completed DMC

• 1 other identifier: ATN 069
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  2 years

• 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.

  2 years

Secondary Outcomes (1)

• 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.

  2 years

Study Arms (3)

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

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

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

Interventions

Focus Group BEHAVIORAL

Focus group using and collecting feedback on the CBT/CM intervention.

1

First Intervention Trial BEHAVIORAL

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.

2

Intervention Trial 2 BEHAVIORAL

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.

3

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

Childrens Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Mount Sinai Medical Center

New York, New York, 10128, United States

Location

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• Website for the Adolescent Trials Network for HIV/AIDS Interventions

MeSH Terms

Conditions

HIV Infections; Substance-Related Disorders

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Larry K. Brown, M.D.

  Adolescent Trials Network

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 23, 2008
• Study Start: April 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: April 1, 2011
• Last Updated: March 6, 2017

Record last verified: 2016-02

Locations

US (3)