NCT02112201

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

4.9 years

First QC Date

April 3, 2014

Last Update Submit

September 14, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Reduction in criminal offending

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

Other Outcomes (1)

  • Reduction in substance use

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

Study Arms (2)

Integrated intervention for parents and adolescent girls

EXPERIMENTAL

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

Behavioral: Integrated intervention for parents and adolescent girls

Treatment as usual

NO INTERVENTION

Treatment as usual

Interventions

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.

Integrated intervention for parents and adolescent girls

Eligibility Criteria

Age13 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • meet criteria for posttraumatic stress disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Dana K Smith, PhD

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2014

First Posted

April 11, 2014

Study Start

September 1, 2013

Primary Completion

August 1, 2018

Study Completion

May 1, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations