The ProGirls Study

NCT ID: NCT02112201

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 416 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2020-05-31

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.

Conditions

Delinquency; HIV Risk; Substance Use; Trauma Exposure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Integrated intervention for parents and adolescent girls

Twelve session parent education and support group; twelve session one-on-one adolescent skills training intervention

Group Type: EXPERIMENTAL

Integrated intervention for parents and adolescent girls

Intervention Type: BEHAVIORAL

The intervention will consist of individually administered preventive curriculum 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.

Treatment as usual

Treatment as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Integrated intervention for parents and adolescent girls

The intervention will consist of individually administered preventive curriculum 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dana K Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Research Institute

Locations

Oregon Research Institute

Eugene, Oregon, United States

Countries

United States

Other Identifiers

DA025857

Identifier Type: -

Identifier Source: org_study_id