Safe, Healthy, Adolescent Relationships and Peers

Adolescent Behavior Clinical Trial

— SHARP-Teen  

Official title:

Preventing Drug Use and Risk Behaviors in Adolescent Girls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02420548
• Other study ID #: 10312013.040
• Secondary ID: 1P50DA035763
• Status: Completed
• Phase: N/A
• Start date: July 1, 2014
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: University of Oregon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 31, 2022
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adolescent Behavior
• Drug Use
• Juvenile Delinquency Unspecified
• Risk Behavior
• Sexual Behavior

Intervention

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

Locations

Country	Name	City	State
United States	University of Oregon	Eugene	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
University of Oregon	National Institute on Drug Abuse (NIDA), Oregon Social Learning Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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