Safe, Healthy, Adolescent Relationships and Peers (SHARP-Teen)

Preventing Drug Use and Risk Behaviors in Adolescent Girls

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.

Study Overview

• Status: Completed
• Conditions: Risk Behavior; Sexual Behavior; Drug Use; Adolescent Behavior; Juvenile Delinquency Unspecified
• Intervention / Treatment: Behavioral: Services as Usual; Behavioral: Parent Ed. and Youth Skills Coaching

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 Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97403
      • University of Oregon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: Services as Usual; Services as usual as provided by community service organizations from which the sample was drawn.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delinquency measured by official arrest records and standardized questionnaires	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.	Up to 12 months
Sexual Risk Behavior	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.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenting measured by change in parenting practices for parents participating in the intervention arm measured by standardized questionnaires	including the Monitoring and Parent-Child Relationship, the Parent Practices Scale, the Parent Daily Report, and the Unrevealed Differences Questionnaire.	Up to 12 months
Substance Use	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.	Up to 12 months

Collaborators and Investigators

• Sponsor: University of Oregon
• Collaborators: National Institute on Drug Abuse (NIDA); Oregon Social Learning Center
• 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

Publications and helpful links

General Publications

• Horn SR, Leve LD, Levitt P, Fisher PA. Childhood adversity, mental health, and oxidative stress: A pilot study. PLoS One. 2019 Apr 26;14(4):e0215085. doi: 10.1371/journal.pone.0215085. eCollection 2019.
• Clark M, Buchanan R, Kovensky R, Leve LD. Partner influences on young women's risky drug and sexual behavior. Reprod Health. 2018 Sep 15;15(1):156. doi: 10.1186/s12978-018-0598-0.
• Clark M, Buchanan R, Leve LD. Young Women's Perspectives of Their Adolescent Treatment Programs: A Qualitative Study. Int J Environ Res Public Health. 2018 Feb 22;15(2):373. doi: 10.3390/ijerph15020373.
• Kovensky R, Anderson D, Leve LD. Early Adversity and Sexual Risk in Adolescence: Externalizing Behaviors as a Mediator. J Child Adolesc Trauma. 2019 Aug 7;13(2):173-184. doi: 10.1007/s40653-019-00278-w. eCollection 2020 Jun.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 14, 2015
• First Submitted That Met QC Criteria: April 16, 2015
• First Posted (Estimate): April 20, 2015

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 10312013.040; 1P50DA035763 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Completely de-identified data shared. Interested investigators must secure IRB approval or waiver from their institution and cerfiy that they will not attempt to discern the identity of any participant.
• IPD Sharing Time Frame: December 2021. No specific end date
• IPD Sharing Access Criteria: Email: leve@uoregon.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No