NCT02420548

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

5.2 years

First QC Date

April 14, 2015

Last Update Submit

May 10, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

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

    Up to 12 months

  • Substance Use

    Up to 12 months

Study Arms (2)

Services as Usual

ACTIVE COMPARATOR

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

Behavioral: Services as Usual

Parent Ed. and Youth Skills Coaching

EXPERIMENTAL

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 CoachingBehavioral: Services as Usual

Interventions

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.

Parent Ed. and Youth Skills Coaching

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

Parent Ed. and Youth Skills CoachingServices as Usual

Eligibility Criteria

Age13 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • are medically fragile
  • have a significant developmental disability
  • have graduated from high school or have a General Educational Diploma (GED)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oregon

Eugene, Oregon, 97403, United States

Location

Related Publications (4)

  • 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.

MeSH Terms

Conditions

Risk-TakingAdolescent BehaviorSexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Leslie Leve, PhD

    University of Oregon

    PRINCIPAL INVESTIGATOR
  • Patti Chamberlain, PhD

    Oregon Social Learning Center

    PRINCIPAL INVESTIGATOR
  • Rohanna Buchanan, PhD

    Oregon Social Learning Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 20, 2015

Study Start

July 1, 2014

Primary Completion

August 31, 2019

Study Completion

December 31, 2022

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
December 2021. No specific end date
Access Criteria
Email: leve@uoregon.edu

Locations