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Completed

NCT Number: NCT02112201

The ProGirls Study

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.

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Key information

Conditions

Delinquency Chemically-Induced Disorders HIV Risk Mental Disorders Substance Use Substance-Related Disorders Trauma Exposure

Age range

13 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Research Institute

Eugene, Oregon, 97403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrated intervention for parents and adolescent girls

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.

Primary outcomes

  1. Reduction in HIV/STIs risk behavior in delinquent girls

    Time frame: 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 outcomes

  1. Reduction in criminal offending

    Time frame: 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.

Other outcomes

  1. Reduction in substance use

    Time frame: Baseline and post intervention (6 mos); 12 & 24 month follow-ups

    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.

Sponsors and collaborators

Lead sponsor

Oregon Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2020
First posted
Apr 11, 2014
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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