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School Health Center Healthy Adolescent Relationship Program (SHARP)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01678378

First Posted: September 5, 2012

Last Update Posted: April 27, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

University of Pittsburgh

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: None (Open Label) Primary Purpose: Prevention
Official Title:	School Health Center Healthy Adolescent Relationship Program

Resource links provided by NLM:

MedlinePlus related topics: School Health

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Recognition of adolescent relationship abuse [ Time Frame: 4 months ]
"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 ]
"Intentions to intervene" -- Between-arm adjusted mean differences on a 9-item summary scale
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:

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.
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.
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.
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


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.

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:

U.S. Department of Justice Final Report This link exits the ClinicalTrials.gov site

Publications:

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 Submitted:	August 30, 2012
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

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