Clinical trial NCT02420548: Safe, Healthy, Adolescent Relationships and Peers
Official title: Preventing Drug Use and Risk Behaviors in Adolescent Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Juvenile Delinquency Unspecified
Risk Behavior
Adolescent Behavior
Sexual Behavior
Drug Use
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: Oregon Social Learning Center
name: National Institute on Drug Abuse (NIDA)
First posted: 2015-04-20
Enrollment: 122
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Delinquency measured by official arrest records and standardized questionnaires
timeFrame: Up to 12 months
measure: Sexual Risk Behavior
timeFrame: 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
timeFrame: Up to 12 months
measure: Substance Use
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
Study officials:
affiliation: University of Oregon
name: Leslie Leve, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Social Learning Center
name: Patti Chamberlain, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Social Learning Center
name: Rohanna Buchanan, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.
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.