HIV Clinical Trial
— STYLEnSOfficial title:
HIV/STI Prevention for Adolescents With Substance Use Disorders in Treatment
Adolescents with substance use disorders (SUD) are at substantial risk for contracting HIV/STIs compared to their counterparts without SUD, yet few HIV/STI sexual risk reduction interventions have been developed to meet their unique needs, and none use a family-based intervention approach, which the literature recommends as the focus for intervention for youth. Current state policies neither require providers in clinics delivering substance use treatment to offer HIV/STI sexual risk reduction nor offer providers tools or training for HIV/STI prevention. There is clear public health need to develop innovative methods of service delivery and effective strategies of HIV/STI sexual risk reduction that address multiple contexts of risk (i.e. family) for this high risk population. The current proposal addresses this need by developing a provider-delivered HIV sexual risk reduction intervention to be implemented in outpatient SUD treatment that: 1) builds the clinics' capacity to help families under their care to more comfortably address the adolescent's sexuality; 2) promotes youth's safer sex practices; and 3) reduces HIV/STI sexual risk behaviors among adolescents with SUD in care.
Status | Completed |
Enrollment | 86 |
Est. completion date | August 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 13 Years to 24 Years |
Eligibility |
Inclusion Criteria: 1. are in care at the pilot sites; 2. are ages 13-24 years; 3. meet criteria for (Diagnostic Statistical Manual) DSM-IV substance abuse diagnosis (patient record); 4. have a caregiver who will consent to their study participation, 5. have a parent/family member willing to enter treatment and participate in study Exclusion Criteria: 1. have mental retardation or pervasive developmental disorder as primary diagnosis; 2. have a medical or psychiatric illness requiring hospitalization; 3. have current psychotic features, or current suicidality; 4. are not English- or Spanish-speaking |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | St. Lukes-Roosevelt Hospital | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Unprotected vaginal or anal sex occasions | 3-months look back | No | |
Secondary | Caregiver-youth communication about sex | The Parent-Adolescent Sexual Communication Scale assesses the process and content of sexual communication between parents and adolescents. Youth and parents complete separate versions. | 3-months look back | No |
Secondary | Caregiver-youth communication about sexual risk behaviors | 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. | 5-minutes | No |
Secondary | Feasibility of conducting the intervention | Determined (yes/no) if the parent and youth attended the intervention sessions | 3-months | No |
Secondary | Acceptability of the intervention | 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. | 3 months | Yes |
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