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The ProGirls Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Oregon Research Institute
Sponsor:
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT02112201
First received: April 3, 2014
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Delinquency
HIV Risk
Substance Use
Trauma Exposure
Behavioral: Integrated intervention for parents and adolescent girls

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preventing HIV/STI Risk Behavior in Girls With Delinquency, Drug Abuse, & Trauma

Resource links provided by NLM:


Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • Reduction in HIV/STIs risk behavior in delinquent girls [ Time Frame: Baseline and post intervention (6 mos); 12 & 24 month follow-ups ] [ Designated as safety issue: No ]
    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:
  • Reduction in criminal offending [ Time Frame: Baseline and post intervention (6 mos); 12 & 24 month follow-ups ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Reduction in substance use [ Time Frame: Baseline and post intervention (6 mos); 12 & 24 month follow-ups ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 400
Study Start Date: September 2013
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Integrated intervention for parents and adolescent girls
Twelve session parent education and support group; twelve session one-on-one adolescent skills training 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.
No Intervention: Treatment as usual
Treatment as usual

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

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02112201

Contacts
Contact: Erika James 541-484-2123 ext 2924 efj@ori.org

Locations
United States, Oregon
Oregon Research Institute Recruiting
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
Oregon Research Institute
Investigators
Principal Investigator: Dana K Smith, PhD Oregon Research Institute
  More Information

No publications provided

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT02112201     History of Changes
Other Study ID Numbers: DA025857
Study First Received: April 3, 2014
Last Updated: October 28, 2014
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on November 24, 2014