School Health Center Healthy Adolescent Relationship Program (SHARP)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Adolescent Relationship Abuse	Behavioral: SHARP Intervention	Not Applicable

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1012 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	School Health Center Healthy Adolescent Relationship Program
Study Start Date :	September 2012
Actual Primary Completion Date :	July 2013
Actual Study Completion Date :	July 2013

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.	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.

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Recognition of adolescent relationship abuse [ Time Frame: 4 months ]
   "Recognition of abusive behaviors" -- Between-arm adjusted mean differences on a 9-item summary scale
2. 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
3. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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. 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

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	14 Years to 19 Years (Child, Adult)
Sexes Eligible for Study:	All
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

U.S. Department of Justice Final Report 

Publications of Results:

Miller E, Goldstein S, McCauley HL, Jones KA, Dick RN, Jetton J, Silverman JG, Blackburn S, Monasterio E, James L, Tancredi DJ. A school health center intervention for abusive adolescent relationships: a cluster RCT. Pediatrics. 2015 Jan;135(1):76-85. doi: 10.1542/peds.2014-2471. Epub 2014 Dec 22.

Dick RN, McCauley HL, Jones KA, Tancredi DJ, Goldstein S, Blackburn S, Monasterio E, James L, Silverman JG, Miller E. Cyber dating abuse among teens using school-based health centers. Pediatrics. 2014 Dec;134(6):e1560-7. doi: 10.1542/peds.2014-0537. Epub 2014 Nov 17.

McCauley HL, Dick RN, Tancredi DJ, Goldstein S, Blackburn S, Silverman JG, Monasterio E, James L, Miller E. Differences by sexual minority status in relationship abuse and sexual and reproductive health among adolescent females. J Adolesc Health. 2014 Nov;55(5):652-8. doi: 10.1016/j.jadohealth.2014.04.020. Epub 2014 Jun 21.

Responsible Party:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT01678378 History of Changes
Other Study ID Numbers:	12020646
First Posted:	September 5, 2012
Last Update Posted:	April 27, 2015
Last Verified:	April 2015

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