HIV/STI Prevention for Adolescents With Substance Use Disorders in Treatment (STYLEnS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01383837|
Recruitment Status : Completed
First Posted : June 28, 2011
Last Update Posted : August 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|HIV Sexually Transmitted Diseases||Behavioral: STYLEnS Behavioral: Health Promotion||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||HIV/STI Prevention for Adolescents With Substance Use Disorders in Treatment|
|Study Start Date :||August 2010|
|Primary Completion Date :||May 2015|
|Study Completion Date :||August 2015|
Multifamily Group HIV/STI Prevention intervention or Single Family Dyad (youth and a parent)
Multifamily group HIV/STI Prevention Intervention or Single Family Dyad (youth and a parent)
Active Comparator: Health Promotion
Health Promotion Intervention - Adolescents only
Behavioral: Health Promotion
Health Promotion Intervention
- Unprotected vaginal or anal sex occasions [ Time Frame: 3-months look back ]
- Caregiver-youth communication about sex [ Time Frame: 3-months look back ]The Parent-Adolescent Sexual Communication Scale assesses the process and content of sexual communication between parents and adolescents. Youth and parents complete separate versions.
- Caregiver-youth communication about sexual risk behaviors [ Time Frame: 5-minutes ]The Parent-Adolescent HIV Preventive Communication Skills Scale assesses the quality and process of parent-child communication; parents and adolescents are videotaped discussing a difficult topic for 5 minutes. An observational coding system is used to match the behavior and interactive changes targeted by the Family-Based component of our intervention (e.g. I-Statements, Negative Vocalizations, and Relationship Quality). Coders will be trained and inter-rater reliability will be assessed.
- Feasibility of conducting the intervention [ Time Frame: 3-months ]Determined (yes/no) if the parent and youth attended the intervention sessions
- Acceptability of the intervention [ Time Frame: 3 months ]Adolescent and caregiver will fill out a structured post-session process measure that assesses adolescent and caregiver feedback specifically regarding intervention content, materials, format, exercises, treatment motivation, personal reactions (strengths and weaknesses, relevance, interest, satisfaction, and comfort) to receiving the interventions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01383837
|United States, New York|
|St. Lukes-Roosevelt Hospital|
|New York, New York, United States, 10025|
|Principal Investigator:||Milton L Wainberg, MD||New York State Psychiatric Institute, Columbia University|