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HIV/STI Prevention for Adolescents With Substance Use Disorders in Treatment (STYLEnS)

Primary Purpose

HIV, Sexually Transmitted Diseases

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
STYLEnS
Health Promotion
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV/STI, Prevention, Adolescents, Substance Use Disorders, Family-based intervention

Eligibility Criteria

13 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Lukes-Roosevelt Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

STYLEnS

Health Promotion

Arm Description

Multifamily Group HIV/STI Prevention intervention or Single Family Dyad (youth and a parent)

Health Promotion Intervention - Adolescents only

Outcomes

Primary Outcome Measures

Unprotected vaginal or anal sex occasions

Secondary Outcome Measures

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.
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.
Feasibility of conducting the intervention
Determined (yes/no) if the parent and youth attended the intervention sessions
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.

Full Information

First Posted
August 18, 2010
Last Updated
August 27, 2015
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01383837
Brief Title
HIV/STI Prevention for Adolescents With Substance Use Disorders in Treatment
Acronym
STYLEnS
Official Title
HIV/STI Prevention for Adolescents With Substance Use Disorders in Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
The incidence of HIV and (sexually transmitted infections) STI continues to rise in the US among youth, and rates of HIV/STI sexual risk behaviors among adolescents with substance use disorders (SUD) are significantly higher compared with their counterparts without SUD. Yet HIV/STI sexual risk reduction is not regularly implemented within adolescent SUD treatment programs. To address this urgent public health priority, the investigators propose first to develop a manualized sexual risk reduction intervention that 1) builds community clinics' capacity to help families in their care to address systematically adolescents' sexuality; 2) promotes the youths' safer sex practices; and 3) reduces HIV/STI sexual risk behaviors among adolescents with SUD in treatment. Second, the investigators propose to pilot test the manualized intervention to examine feasibility and acceptability of implementation in real-world settings and determine optimal research parameters for such settings in preparation for a randomized clinical trial (RCT). The intervention development process will use a Community Based Participatory Research model of adaptation and development that has been successfully implemented by the PI in other settings. The investigators will conduct formative work to guide adaptation of a multi-family group HIV/STI sexual risk reduction intervention that has demonstrated efficacy with youth, ages 13-18, who have non-SUD psychiatric disorders (Project STYLE: Strengthening Today's Youth Life Experience; R01 MH63008; PI: Brown). This formative work (Phase 1 - protocol 6183) will leverage the research sample of CASALEAP, an ongoing NIDA-funded, large-scale naturalistic study of the effectiveness of outpatient SUD treatment for adolescent (R01 DA019607; PI: Hogue). The resulting new manualized intervention (STYLEnS: STYLE and Substance) then will be pilot-tested (Phase 2 - protocol 6622) with a sample of male and female adolescents with SUD (n=60) in treatment in three well-established New York City mental health outpatient treatment programs which are typical of those for adolescents with SUD and in which the investigators have active partnerships. Pilot participants will be randomly assigned to either STYLEnS or an attention control intervention (Health Promotion). Participants will receive a full-day group intervention on the day of randomization (multi-family, caregivers alone and adolescents alone), return in two weeks for an individual adolescent/caregiver dyad session, and participate in a half-day booster group session three months later. The pilot test will evaluate the feasibility and acceptability of conducting an intervention in outpatient clinics treating adolescents with SUD, examine optimal factors influencing research methods, and estimate intervention parameters for a RCT. Acceptability and feasibility will be assessed using process measures following each session as well as after the intervention is completed. The investigators will assess change in sexual risk behavior outcomes from baseline to 3 months post-intervention. This study will lay the groundwork for refining the design of a RCT of the new intervention. Implementing a HIV/STI sexual risk reduction intervention in clinics providing SUD treatment represents an innovative and potentially cost-effective approach to enable typically overburdened SUD treatment providers to address the heightened HIV/STI risk in SUD youth. This proposal responds to the need to develop HIV/STI sexual risk reduction intervention services for adolescents with SUD that can be applied in and easily disseminated to clinical settings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Sexually Transmitted Diseases
Keywords
HIV/STI, Prevention, Adolescents, Substance Use Disorders, Family-based intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STYLEnS
Arm Type
Experimental
Arm Description
Multifamily Group HIV/STI Prevention intervention or Single Family Dyad (youth and a parent)
Arm Title
Health Promotion
Arm Type
Active Comparator
Arm Description
Health Promotion Intervention - Adolescents only
Intervention Type
Behavioral
Intervention Name(s)
STYLEnS
Intervention Description
Multifamily group HIV/STI Prevention Intervention or Single Family Dyad (youth and a parent)
Intervention Type
Behavioral
Intervention Name(s)
Health Promotion
Intervention Description
Health Promotion Intervention
Primary Outcome Measure Information:
Title
Unprotected vaginal or anal sex occasions
Time Frame
3-months look back
Secondary Outcome Measure Information:
Title
Caregiver-youth communication about sex
Description
The Parent-Adolescent Sexual Communication Scale assesses the process and content of sexual communication between parents and adolescents. Youth and parents complete separate versions.
Time Frame
3-months look back
Title
Caregiver-youth communication about sexual risk behaviors
Description
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.
Time Frame
5-minutes
Title
Feasibility of conducting the intervention
Description
Determined (yes/no) if the parent and youth attended the intervention sessions
Time Frame
3-months
Title
Acceptability of the intervention
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: are in care at the pilot sites; are ages 13-24 years; meet criteria for (Diagnostic Statistical Manual) DSM-IV substance abuse diagnosis (patient record); have a caregiver who will consent to their study participation, have a parent/family member willing to enter treatment and participate in study Exclusion Criteria: have mental retardation or pervasive developmental disorder as primary diagnosis; have a medical or psychiatric illness requiring hospitalization; have current psychotic features, or current suicidality; are not English- or Spanish-speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milton L Wainberg, MD
Organizational Affiliation
New York State Psychiatric Institute, Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Lukes-Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States

12. IPD Sharing Statement

Learn more about this trial

HIV/STI Prevention for Adolescents With Substance Use Disorders in Treatment

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