View Clinical Trial (Medical Research Study)
HIV/STI Prevention for Adolescents With Substance Use Disorders in Treatment
| City: |
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New York |
| State: |
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New York |
| Zip Code: |
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10025 |
| Conditions: |
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HIV - Sexually Transmitted Diseases |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01383837 |
| Primary Contact: |
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Principal Investigator
Milton L Wainberg, MD
New York State Psychiatric Institute, Columbia University
Milton L Wainberg, MD
Phone: 212-543-6175
Email: mlw35@columbia.edu
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| Backup Contact: |
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Email: crisb21@gmail.com
Cristiane Borges, MD
Phone: 212-568-4513
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| Location Contact: |
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New York, New York 10025
United States
Susan Tross, PhD
Phone: 917-597-7093
Email: st130@columbia.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
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