School Health Center Healthy Adolescent Relationship Program

Adolescent Relationship Abuse Clinical Trial

— SHARP  

Official title:

School Health Center Healthy Adolescent Relationship Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01678378
• Other study ID #: 12020646
• Status: Completed
• Phase: N/A
• First received: August 30, 2012
• Last updated: April 24, 2015
• Start date: September 2012
• Est. completion date: July 2013

Study information

• Verified date: April 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1012
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 19 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adolescent Relationship Abuse

Intervention

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.

Locations

Country	Name	City	State
United States	Public Health Institute	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 — View Citation

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recognition of adolescent relationship abuse	"Recognition of abusive behaviors" -- Between-arm adjusted mean differences on a 9-item summary scale	4 months	No
Primary	Intentions to positively intervene in adolescent relationship abuse among peers	"Intentions to intervene" -- Between-arm adjusted mean differences on a 9-item summary scale	4 months	No
Primary	Knowledge of violence victimization resources	"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	No
Secondary	Disclosure of adolescent relationship abuse to school health center providers	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)	No
Secondary	Uptake of adolescent relationship abuse harm reduction and utilization of resources	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	No
Secondary	Adolescent relationship abuse victimization	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	No
Secondary	Knowledge of harm reduction strategies	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	No

External Links

•   U.S. Department of Justice Final Report