Clinical trial NCT01678378: School Health Center Healthy Adolescent Relationship Program
Official title: School Health Center Healthy Adolescent Relationship Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Relationship Abuse
Keywords: 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
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2012-09-05
Enrollment: 1012
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Recognition of adolescent relationship abuse
timeFrame: 4 months
measure: Intentions to positively intervene in adolescent relationship abuse among peers
timeFrame: 4 months
measure: Knowledge of violence victimization resources
timeFrame: 4 months
Secondary outcomes:
measure: Disclosure of adolescent relationship abuse to school health center providers
timeFrame: baseline (after clinic visit)
measure: Uptake of adolescent relationship abuse harm reduction and utilization of resources
timeFrame: 4 months
measure: Adolescent relationship abuse victimization
timeFrame: 4 months
measure: Knowledge of harm reduction strategies
timeFrame: 4 months
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Public Health Institute
state: California
Study officials:
affiliation: Pubic Health Institute
name: Sandi Goldstein
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh, Children's Hospital of Pittsburgh of UPMC
name: Elizabeth Miller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: 10.1542/peds.2014-2471. Epub 2014 Dec 22.
citation: 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.
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;55(5):652-8. doi: 10.1016/j.jadohealth.2014.04.020. Epub 2014 Jun 21.
citation: Hill AL, Jones KA, McCauley HL, Tancredi DJ, Silverman JG, Miller E. Reproductive Coercion and Relationship Abuse Among Adolescents and Young Women Seeking Care at School Health Centers. Obstet Gynecol. 2019 Aug;134(2):351-359. doi: 10.1097/AOG.0000000000003374.