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Adolescent Relationship AbuseSHARPNCT01678378

School Health Center Healthy Adolescent Relationship Program

A study testing SHARP Intervention in people with Adolescent Relationship Abuse, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 14 to 19 years
Conditions the study is for
Adolescent Relationship Abuse
What is being tested?
SHARP Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,012 participants
Where
1 siteUnited States
Study dates
Sep 2012to Jul 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Public Health Institute

    Oakland, California, 94607

Other trials in United States

About this study

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.

Being tested
SHARP Intervention
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
Medical subject headings
Harm Reduction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHARP InterventionBehavioural

    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.

Study groups in NCT01678378
Study groupRoleWhat they receive
SHARP InterventionExperimentalSchool health centers randomized to the SHARP Intervention will be trained to address adolescent relationship abuse with school health center clients.
Receives: Behavioral: SHARP Intervention
ControlNo interventionSchool health centers randomized to Control will provide standard of care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recognition of adolescent relationship abuse

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

    Measured: 4 months

  2. Intentions to positively intervene in adolescent relationship abuse among peers

    "Intentions to intervene" -- Between-arm adjusted mean differences on a 9-item summary scale

    Measured: 4 months

  3. 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.

    Measured: 4 months

Secondary outcomes (4)

  1. 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.

    Measured: baseline (after clinic visit)

  2. 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.

    Measured: 4 months

  3. 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.

    Measured: 4 months

  4. 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

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionJul 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,012 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01678378
Sponsor's protocol ID
12020646
Acronym
SHARP
Status last verified
Apr 2015
First submitted
30 Aug 2012
Last updated
27 Apr 2015
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 25535265

  • 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.

    PubMed 25404724

  • 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.

    PubMed 24962502

  • 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.

    PubMed 31306331

Questions about this trial

What is this clinical trial studying?

A study testing SHARP Intervention in people with Adolescent Relationship Abuse, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recognition of adolescent relationship abuse (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01678378, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2015; AzTrials last refreshed its copy on 31 Oct 2026.

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