NCT01678378

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,012

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

April 27, 2015

Status Verified

April 1, 2015

Enrollment Period

10 months

First QC Date

August 30, 2012

Last Update Submit

April 24, 2015

Conditions

Keywords

AdolescentInterventionFemaleMaleInterpersonal RelationsSchool Health ServicesCommunity-Based Participatory ResearchRandomized Controlled TrialHealth Care ProviderTraining ProgramHarm ReductionPreventionReproductive CoercionTech-Based AbuseSocial EnvironmentSexual Partners

Outcome Measures

Primary Outcomes (3)

  • Recognition of adolescent relationship abuse

    "Recognition of abusive behaviors" -- Between-arm adjusted mean differences on a 9-item summary scale

    4 months

  • 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

  • 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

Secondary Outcomes (4)

  • Disclosure of adolescent relationship abuse to school health center providers

    baseline (after clinic visit)

  • Uptake of adolescent relationship abuse harm reduction and utilization of resources

    4 months

  • Adolescent relationship abuse victimization

    4 months

  • Knowledge of harm reduction strategies

    4 months

Study Arms (2)

SHARP Intervention

EXPERIMENTAL

School health centers randomized to the SHARP Intervention will be trained to address adolescent relationship abuse with school health center clients.

Behavioral: SHARP Intervention

Control

NO INTERVENTION

School health centers randomized to Control will provide standard of care.

Interventions

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.

SHARP Intervention

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age 14-19
  • receiving services at one of the eight SHARP Intervention school health centers
  • able to read English or Spanish

You may not qualify if:

  • clients not of the specified age range
  • clients who are intoxicated or otherwise not able to provide their own consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health Institute

Oakland, California, 94607, United States

Location

Related Publications (4)

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Harm Reduction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Sandi Goldstein

    Pubic Health Institute

    PRINCIPAL INVESTIGATOR
  • Elizabeth Miller, MD, PhD

    University of Pittsburgh, Children's Hospital of Pittsburgh of UPMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2012

First Posted

September 5, 2012

Study Start

September 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

April 27, 2015

Record last verified: 2015-04

Locations