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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by New York State Psychiatric Institute
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01383837
First received: August 18, 2010
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
HIV
Sexually Transmitted Diseases
Behavioral: STYLEnS
Behavioral: Health Promotion
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: HIV/STI Prevention for Adolescents With Substance Use Disorders in Treatment

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Unprotected vaginal or anal sex occasions [ Time Frame: 3-months look back ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Caregiver-youth communication about sex [ Time Frame: 3-months look back ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Determined (yes/no) if the parent and youth attended the intervention sessions

  • Acceptability of the intervention [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 188
Study Start Date: August 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STYLEnS
Multifamily Group HIV/STI Prevention intervention
Behavioral: STYLEnS
Multifamily group HIV/STI Prevention Intervention
Other Name: Multifamily group HIV/STI Prevention Intervention
Active Comparator: Health Promotion
Health Promotion Intervention - Adolescents only
Behavioral: Health Promotion
Health Promotion Intervention
Other Name: Health Promotion

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 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 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.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. are in care at the pilot sites;
  2. are ages 13-18 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383837

Contacts
Contact: Milton L Wainberg, MD 646-774-6430 mlw35@columbia.edu
Contact: Katherine Collier, MD 646-774-6911 collier@nyspi.columbia.edu

Locations
United States, New York
St. Lukes-Roosevelt Hospital Recruiting
New York, New York, United States, 10025
Contact: Susan Tross, PhD    917-597-7093    st130@columbia.edu   
Contact: Phillip Clemmey, PhD    212-523-1697    pclemmey@chpnet.org   
Principal Investigator: Susan Tross, PhD         
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Milton L Wainberg, MD New York State Psychiatric Institute, Columbia University
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01383837     History of Changes
Other Study ID Numbers: 6183
Study First Received: August 18, 2010
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
HIV/STI
Prevention
Adolescents
Substance Use Disorders
Family-based intervention

Additional relevant MeSH terms:
Substance-Related Disorders
Sexually Transmitted Diseases
Chemically-Induced Disorders
Mental Disorders
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 22, 2014