Overview

This trial is active, not recruiting.

Conditions juvenile delinquency unspecified, risk behavior, adolescent behavior, sexual behavior, drug use
Treatments parent ed. and youth skills coaching, services as usual
Sponsor University of Oregon
Collaborator Oregon Social Learning Center
Start date July 2014
End date August 2019
Trial size 123 participants
Trial identifier NCT02420548, 10312013.040, 1P50DA035763

Summary

The Safe, Healthy, Adolescent Relationships and Peers study seeks to understand some of the factors that contribute to the behaviors and health of teen girls, such as girl's friendships, their dating behaviors, their risk-taking behaviors, and their knowledge about how to make healthy choices. This study will inform us on ways to help teen girls engage in safe and healthy relationships and adjustment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Participants continue with any services they may be receiving outside of the study.
services as usual
Services as usual as provided by community service organizations from which the sample was drawn.
(Experimental)
The experimental intervention will have two components: (1) a caregiver parenting group, including all caregiver types (biological, foster, kinship), that meets weekly for 90-minutes for four months, focused on increasing parenting skills, and (2) a Life Coach component where trained and supported skills coaches meet individually with youth weekly for 60 minutes over the same four-month period to build the girls' social skills and peer/partner relationships skills.
parent ed. and youth skills coaching
The experimental intervention will have two components: (1) a caregiver parenting group, including all caregiver types (biological, foster, kinship), that meets weekly for 90-minutes for four months, focused on increasing parenting skills, and (2) a Life Coach component where trained and supported skills coaches meet individually with youth weekly for 60 minutes over the same four-month period to build the girls' social skills and peer/partner relationships skills.
services as usual
Services as usual as provided by community service organizations from which the sample was drawn.

Primary Outcomes

Measure
Delinquency measured by official arrest records and standardized questionnaires
time frame: Up to 12 months
Sexual Risk Behavior
time frame: Up to 12 months

Secondary Outcomes

Measure
Parenting measured by change in parenting practices for parents participating in the intervention arm measured by standardized questionnaires
time frame: Up to 12 months
Substance Use
time frame: Up to 12 months

Eligibility Criteria

Female participants from 13 years up to 18 years old.

Inclusion Criteria: - reside in Lane County and within 70 miles of the University of Oregon - have a current caregiver - both girl and caregiver are fluent in English Exclusion Criteria: - are medically fragile - have a significant developmental disability - have graduated from high school or have a General Educational Diploma (GED)

Additional Information

Official title Preventing Drug Use and Risk Behaviors in Adolescent Girls
Principal investigator Leslie Leve, PhD
Description Initiation of drug use and participation in sexual-risk behaviors such as having multiple sexual partners, unprotected sexual intercourse, and intercourse with drug users are all too common among girls with at-risk histories, such as those who have experienced poverty, abuse, neglect, or been in the juvenile justice system. Studies consistently find that these girls have disproportionately high rates of these problems that, in addition to increasing risk for negative outcomes, have other costly sequelae such as drug addiction, early pregnancy, sexually-transmitted infections (STIs) and HIV contraction, delinquency, and early mortality (e.g., Santelli et al., 2001; Stueve et al., 2005). In our prior work, the investigators showed that the investigators could prevent early onset sexual intercourse and tobacco and marijuana initiation in pre-teen girls in foster care. Although this intervention, delivered to girls who were 11-years old and had not yet entered middle school, demonstrated efficacy, the investigators know very little about how to prevent the more serious and costly sexual-risk and illicit drug use behaviors in at-risk girls during the high school years, a period of risk for engagement in such behaviors. This study builds from this prior work to develop a new intervention for teenage girls with early adversity.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Oregon.