School Health Center Healthy Adolescent Relationship Program (SHARP)

April 24, 2015 updated by: University of Pittsburgh
This community-partnered participatory study will work within high school health centers (SHCs) to test, via a 2-armed cluster randomized controlled trial, a multi-level intervention to reduce adolescent relationship abuse (ARA) among adolescents ages 14-19. The goal of this study is to examine the effectiveness of the School Health Center Healthy Adolescent Relationships Program (SHARP) intervention in SHCs on individual SHC clients, the SHC clinic environment, and the schools in which the SHCs are located. Evaluation of the intervention will involve random assignment of eight comparable SHCs in the Greater Bay Area of California that provide comprehensive health services, to either intervention or control sites. Adolescent females and males ages 14-19 seeking care at any of these SHCs (N=1200) will be assessed via audio computer-assisted survey instrument (ACASI) at baseline and 16-20 weeks follow-up to examine intervention effects on knowledge and self-efficacy regarding ARA, harm reduction and ARA-related resources as well as intentions to intervene with peers. For youth reporting recent ARA victimization, the investigators will assess for increases in ARA disclosure, resource utilization, as well as reduction in ARA victimization.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1012

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Oakland, California, United States, 94607
        • Public Health Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 14-19
  • receiving services at one of the eight SHARP Intervention school health centers
  • able to read English or Spanish

Exclusion Criteria:

  • clients not of the specified age range
  • clients who are intoxicated or otherwise not able to provide their own consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHARP Intervention
School health centers randomized to the SHARP Intervention will be trained to address adolescent relationship abuse with school health center clients.
Providers and staff located in high school school health centers (i.e., nurse practitioners, nurses,physicians, health educators, medical assistants) will be trained to address adolescent relationship abuse with school health center clients using knowledge, skills, and resources gained through the SHARP Intervention training. The training includes strategies to help youth recognize adolescent relationship abuse among themselves and their peers, to learn strategies to increase safety (harm reduction), and to utilize adolescent relationship abuse-related resources.
No Intervention: Control
School health centers randomized to Control will provide standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recognition of adolescent relationship abuse
Time Frame: 4 months
"Recognition of abusive behaviors" -- Between-arm adjusted mean differences on a 9-item summary scale
4 months
Intentions to positively intervene in adolescent relationship abuse among peers
Time Frame: 4 months
"Intentions to intervene" -- Between-arm adjusted mean differences on a 9-item summary scale
4 months
Knowledge of violence victimization resources
Time Frame: 4 months
"Knowledge of resources" -- Between arm differences of summary score of single items which assess the extent to which participants are aware of places they could go for specific support services.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disclosure of adolescent relationship abuse to school health center providers
Time Frame: baseline (after clinic visit)
Between-arm adjusted differences in proportion disclosing adolescent relationship abuse (ARA) to school health providers at baseline. Comparisons restricted to subgroup of clients reporting ARA on ACASI survey at baseline.
baseline (after clinic visit)
Uptake of adolescent relationship abuse harm reduction and utilization of resources
Time Frame: 4 months
Between-arm adjusted differences in proportion reporting any use of ARA resources in the 3-month period prior to the follow-up survey. Comparisons restricted to clients reporting ARA on ACASI survey at baseline.
4 months
Adolescent relationship abuse victimization
Time Frame: 4 months
Between-arm adjusted differences in proportion screened positive for at least one adolescent relationship abuse (ARA) behavior, based on screening tests for reproductive coercion, intimate partner and sexual violence victimization and psychological abuse. Comparisons restricted to clients reporting ARA at baseline.
4 months
Knowledge of harm reduction strategies
Time Frame: 4 months
Participants are presented with a series of harm reduction behaviors to reduce risk for ARA, and asked to what extent they are aware of these strategies and self-efficacy in enacting these behaviors based on a 7-point Likert-type scale
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sandi Goldstein, Pubic Health Institute
  • Principal Investigator: Elizabeth Miller, MD, PhD, University of Pittsburgh, Children's Hospital of Pittsburgh of UPMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

August 30, 2012

First Submitted That Met QC Criteria

September 4, 2012

First Posted (Estimate)

September 5, 2012

Study Record Updates

Last Update Posted (Estimate)

April 27, 2015

Last Update Submitted That Met QC Criteria

April 24, 2015

Last Verified

April 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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