The ProGirls Study

Substance Use Clinical Trial

Official title:

Preventing HIV/STI Risk Behavior in Girls With Delinquency, Drug Abuse, & Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02112201
• Other study ID #: DA025857
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: May 2020

Study information

• Verified date: September 2020
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: May 2020
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Delinquency
• HIV Risk
• Substance Use
• Trauma Exposure
• Wounds and Injuries

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reduction in substance use	Girls in the intervention condition are expected to have significantly lower rates of substance use 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 urinary analysis.	Baseline and post intervention (6 mos); 12 & 24 month follow-ups
Primary	Reduction in HIV/STIs risk behavior in delinquent girls	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.	Baseline and post intervention (6 mos); 12 & 24 month follow-ups
Secondary	Reduction in criminal offending	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.	Baseline and post intervention (6 mos); 12 & 24 month follow-ups