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The ProGirls Study

Primary Purpose

Delinquency, HIV Risk, Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrated intervention for parents and adolescent girls
Sponsored by
Oregon Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delinquency

Eligibility Criteria

13 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Oregon Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Integrated intervention for parents and adolescent girls

Treatment as usual

Arm Description

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

Treatment as usual

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 3, 2014
Last Updated
September 14, 2020
Sponsor
Oregon Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02112201
Brief Title
The ProGirls Study
Official Title
Preventing HIV/STI Risk Behavior in Girls With Delinquency, Drug Abuse, & Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
May 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delinquency, HIV Risk, Substance Use, Trauma Exposure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
416 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrated intervention for parents and adolescent girls
Arm Type
Experimental
Arm Description
Twelve session parent education and support group; twelve session one-on-one adolescent skills training intervention
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Integrated intervention for parents and adolescent girls
Intervention Description
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 Outcome Measure Information:
Title
Reduction in HIV/STIs risk behavior in delinquent girls
Description
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.
Time Frame
Baseline and post intervention (6 mos); 12 & 24 month follow-ups
Secondary Outcome Measure Information:
Title
Reduction in criminal offending
Description
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.
Time Frame
Baseline and post intervention (6 mos); 12 & 24 month follow-ups
Other Pre-specified Outcome Measures:
Title
Reduction in substance use
Description
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.
Time Frame
Baseline and post intervention (6 mos); 12 & 24 month follow-ups

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana K Smith, PhD
Organizational Affiliation
Oregon Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States

12. IPD Sharing Statement

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The ProGirls Study

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