Clinical trial NCT02112201: The ProGirls Study
Official title: Preventing HIV/STI Risk Behavior in Girls With Delinquency, Drug Abuse, & Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delinquency
HIV Risk
Substance Use
Trauma Exposure
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
First posted: 2014-04-11
Enrollment: 416
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Girls in the juvenile justice system who have high rates of delinquency, drug abuse, and trauma are particularly at risk for engaging in risky sexual behavior and for contracting HIV/AIDS or other sexually transmitted infections (STIs). No effective prevention programs for girls who have this combination of behaviors is known to exist at this time. Researchers are developing, assessing, and implementing a family-centered prevention program to decrease girls' participation in the risky behaviors associated with the spread of HIV and STIs. The program also includes a group-based training and support program for parents.

Detailed description: This study aims to test an intervention to reduce HIV/STI risk behavior among girls in the juvenile justice system with the triple-threat risk of delinquency, drug abuse, and trauma. This is a competing continuation of the ProTeens study (Preventing Drug Abuse \& HIV/AIDS in Delinquent Youths: An Integrated Intervention) which focused on testing a family-centered intervention for treating HIV risk, drug use, and delinquency in boys. The current study will adapt the ProTeens intervention for girls. Girls and their parent(s) will be randomly assigned to either a family-centered intervention condition (INT; n = 100) or to an active comparison condition (n = 100) consisting of group therapy and case management (GCM). The INT condition will consist of individually administered HIV preventive intervention for adolescent girls involved in the juvenile justice system that integrally addresses delinquency, drug abuse, and trauma exposure, along with group-based training and support for parents. The girl and parent components will run concurrently for three months. The GCM condition will consist of group therapy and case management for girls provided as usual by the juvenile justice department. We will examine intervention effects on proximal outcomes measured at 12 months, the effects of childhood adversity on proximal outcomes, and the mediation of intervention effects. Longer term outcomes will be measured at 24 months. Data will be collected through in-person interviews and questionnaires from focal participants and their parents, official arrest records, and urinary analysis.

Eligibility criteria: Inclusion Criteria:

* female, age 13-18 years
* living in Lane County, Oregon
* living at home (biological/adoptive, foster, or other relative care)
* at least one criminal referral and on probation or a formal accountability contract with the juvenile justice system
* documented drug use from juvenile justice risk assessment
* traumatic exposure
* no imminent plans to be placed in out-of-home care

Exclusion Criteria:

* meet criteria for posttraumatic stress disorder

Primary outcomes:
measure: Reduction in HIV/STIs risk behavior in delinquent girls
timeFrame: Baseline and post intervention (6 mos); 12 & 24 month follow-ups
Secondary outcomes:
measure: Reduction in criminal offending
timeFrame: Baseline and post intervention (6 mos); 12 & 24 month follow-ups
Other outcomes:
measure: Reduction in substance use
timeFrame: Baseline and post intervention (6 mos); 12 & 24 month follow-ups
Locations:
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
affiliation: Oregon Research Institute
name: Dana K Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: