- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01678378
School Health Center Healthy Adolescent Relationship Program (SHARP)
April 24, 2015 updated by: University of Pittsburgh
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1012
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Oakland, California, United States, 94607
- Public Health Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: SHARP Intervention
School health centers randomized to the SHARP Intervention will be trained to address adolescent relationship abuse with school health center clients.
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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.
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No Intervention: Control
School health centers randomized to Control will provide standard of care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recognition of adolescent relationship abuse
Time Frame: 4 months
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"Recognition of abusive behaviors" -- Between-arm adjusted mean differences on a 9-item summary scale
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4 months
|
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Intentions to positively intervene in adolescent relationship abuse among peers
Time Frame: 4 months
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"Intentions to intervene" -- Between-arm adjusted mean differences on a 9-item summary scale
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4 months
|
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Knowledge of violence victimization resources
Time Frame: 4 months
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"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.
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4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disclosure of adolescent relationship abuse to school health center providers
Time Frame: baseline (after clinic visit)
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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.
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baseline (after clinic visit)
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Uptake of adolescent relationship abuse harm reduction and utilization of resources
Time Frame: 4 months
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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.
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4 months
|
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Adolescent relationship abuse victimization
Time Frame: 4 months
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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.
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4 months
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Knowledge of harm reduction strategies
Time Frame: 4 months
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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
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4 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sandi Goldstein, Pubic Health Institute
- Principal Investigator: Elizabeth Miller, MD, PhD, University of Pittsburgh, Children's Hospital of Pittsburgh of UPMC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
August 30, 2012
First Submitted That Met QC Criteria
September 4, 2012
First Posted (Estimate)
September 5, 2012
Study Record Updates
Last Update Posted (Estimate)
April 27, 2015
Last Update Submitted That Met QC Criteria
April 24, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 12020646
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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