The ProGirls Study

Not Applicable

Completed

• Conditions: Delinquency; Trauma Exposure; HIV Risk; Substance Use
• Interventions: Behavioral: Integrated intervention for parents and adolescent girls

• Registration Number: NCT02112201
• Lead Sponsor: Oregon Research Institute

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-04-03
• Study First Submitted QC: 2014-04-09
• Study First Posted: 2014-04-11
• Primary Completion: 2018-08
• Study Completion: 2020-05
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 416

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrated intervention for parents and adolescent girls	Integrated intervention for parents and adolescent girls	Twelve session parent education and support group; twelve session one-on-one adolescent skills training intervention

Primary Outcome Measures

Name	Time	Method
Reduction in HIV/STIs risk behavior in delinquent girls	Baseline and post intervention (6 mos); 12 & 24 month follow-ups	Girls in the intervention condition are expected to have significantly lower rates of HIV/STI risk behaviors compared to girls in the control condition at each of the time-points post-baseline. Data will be collected through in-person interviews and questionnaires from focal participants and their parents.

Secondary Outcome Measures

Name	Time	Method
Reduction in criminal offending	Baseline and post intervention (6 mos); 12 & 24 month follow-ups	Girls in the intervention condition are expected to have significantly lower rates of criminal offending behavior compared to girls in the control condition at each of the time points post-baseline. Data will be collected through in-person interviews and questionnaires from focal participants and their parents and official arrest records.

Trial Locations

Locations (1)

Oregon Research Institute; 🇺🇸 Eugene, Oregon, United States