Skip to main content
OpenTrials
Completed

NCT Number: NCT02420548

Safe, Healthy, Adolescent Relationships and Peers

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

13 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Oregon

Eugene, Oregon, 97403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Parent Ed. and Youth Skills Coaching

Behavioral

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

Behavioral

Services as usual as provided by community service organizations from which the sample was drawn.

Primary outcomes

  1. Delinquency measured by official arrest records and standardized questionnaires

    Time frame: Up to 12 months

    Reduction in delinquent behaviors for teens participating in the intervention arm measured by official arrest records and standardized questionnaires, including the Youth Symptom inventory, the Elliott Self-report Delinquency Scale, the Achenbach System of Empirically Based Assessment, and the Parent Daily Report.

  2. Sexual Risk Behavior

    Time frame: Up to 12 months

    Reduction in high risk sexual behaviors for teens participating in the intervention arm measured by standardized questionnaires, including Partner and Peer Behavior, Conflict in Adolescent Dating, Sexual Health Scale, and the Parent Daily Report.

Secondary outcomes

  1. Parenting measured by change in parenting practices for parents participating in the intervention arm measured by standardized questionnaires

    Time frame: Up to 12 months

    including the Monitoring and Parent-Child Relationship, the Parent Practices Scale, the Parent Daily Report, and the Unrevealed Differences Questionnaire.

  2. Substance Use

    Time frame: Up to 12 months

    Reduction in substance use for teens participating in the intervention arm measured by urine analysis and standardized questionnaires, including the Youth Symptom Inventory, the World Health Organization Composite International Diagnostic Interview, and the Parent Daily Report.

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • Oregon Social Learning Center

Registry information

Official study title

Preventing Drug Use and Risk Behaviors in Adolescent Girls

Acronym: SHARP-Teen

Important dates

Study start
2014
Primary completion
2019
Study completion
2022
First posted
Apr 20, 2015
Registry last updated
May 11, 2023

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.

Published trials that share one or more normalized conditions with this study.