School Health Center Healthy Adolescent Relationship Program (SHARP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01678378
First received: August 30, 2012
Last updated: July 3, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Adolescent Relationship Abuse
Behavioral: SHARP Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: School Health Center Healthy Adolescent Relationship Program

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Recognition of adolescent relationship abuse [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    "Recognition of abusive behaviors" -- Between-arm adjusted mean differences on a 9-item summary scale

  • Intentions to positively intervene in adolescent relationship abuse among peers [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    "Intentions to intervene" -- Between-arm adjusted mean differences on a 9-item summary scale

  • Knowledge of violence victimization resources [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    "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.


Secondary Outcome Measures:
  • Disclosure of adolescent relationship abuse to school health center providers [ Time Frame: baseline (after clinic visit) ] [ Designated as safety issue: No ]
    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.

  • Uptake of adolescent relationship abuse harm reduction and utilization of resources [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.

  • Adolescent relationship abuse victimization [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.

  • Knowledge of harm reduction strategies [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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


Enrollment: 1012
Study Start Date: September 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SHARP Intervention
School health centers randomized to the SHARP Intervention will be trained to address adolescent relationship abuse with school health center clients.
Behavioral: SHARP Intervention
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.

  Eligibility

Ages Eligible for Study:   14 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678378

Locations
United States, California
Public Health Institute
Oakland, California, United States, 94607
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Sandi Goldstein Pubic Health Institute
Principal Investigator: Elizabeth Miller, MD, PhD University of Pittsburgh, Children's Hospital of Pittsburgh of UPMC
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01678378     History of Changes
Other Study ID Numbers: 12020646
Study First Received: August 30, 2012
Last Updated: July 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Adolescent
Intervention
Female
Male
Interpersonal Relations
School Health Services
Community-Based Participatory Research
Randomized Controlled Trial
Health Care Provider
Training Program
Harm Reduction
Prevention
Reproductive Coercion
Tech-Based Abuse
Social Environment
Sexual Partners

ClinicalTrials.gov processed this record on October 30, 2014