SHARP-Teen: Safe, Healthy, Adolescent Relationships and Peers

Sponsor
University of Oregon (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02420548
Collaborator
Oregon Social Learning Center (Other), National Institute on Drug Abuse (NIDA) (NIH)
122
1
2
102
1.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Parent Ed. and Youth Skills Coaching
  • Behavioral: Services as Usual
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
122 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Preventing Drug Use and Risk Behaviors in Adolescent Girls
Actual Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Aug 31, 2019
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Services as Usual

Participants continue with any services they may be receiving outside of the study.

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

Experimental: 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.

Behavioral: 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.

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

Outcome Measures

Primary Outcome Measures

  1. Delinquency measured by official arrest records and standardized questionnaires [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 [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 18 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Oregon Eugene Oregon United States 97403

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Leslie Leve, PhD, University of Oregon
  • Principal Investigator: Patti Chamberlain, PhD, Oregon Social Learning Center
  • Study Director: Rohanna Buchanan, PhD, Oregon Social Learning Center

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
University of Oregon
ClinicalTrials.gov Identifier:
NCT02420548
Other Study ID Numbers:
  • 10312013.040
  • 1P50DA035763
First Posted:
Apr 20, 2015
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 1, 2022