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Clinical Trials/NCT02782728
NCT02782728
Completed
Not Applicable

Trauma-informed Personalized Scripts (TIPS) to Address Relationship Abuse and Reproductive Coercion in Family Planning Clinics

University of Pittsburgh1 site in 1 country240 target enrollmentJune 2016
ConditionsViolenceAbuse

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Violence
Sponsor
University of Pittsburgh
Enrollment
240
Locations
1
Primary Endpoint
Quality of intervention delivery by provider
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This pilot study will evaluate a computer-based intervention titled "Trauma-informed Personalized Scripts" (TIPS). The goal of this intervention is to improve patient-provider communication about sensitive topics such as intimate partner violence (IPV) and reproductive coercion (RC). The main aim of this study is to pilot test TIPS in family planning clinics using a randomized study design to compare the basic version of TIPS (a computer-based assessment with provider scripts only) to an enhanced TIPS containing a tailored brief intervention for patients along with provider scripts. The investigators plan to recruit 240 female patients ages 16-29 for this study.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
December 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elizabeth Miller

Chief of Adolescent Medicine, Professor of Pediatrics

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • age 16-29
  • English speaking
  • Plans to stay in the area for next 6 months

Exclusion Criteria

  • Female clients not of the specified age range.
  • Clients who are intoxicated or otherwise not able to provide their own consent will not be eligible to participate.
  • Clients who are not able to read English will also be excluded from this pilot study as the survey questions presented via the tablet computer have not been validated yet in any other language.

Outcomes

Primary Outcomes

Quality of intervention delivery by provider

Time Frame: Immediately following clinic visit

Assessment of delivery of brief intervention previously tested and found to be helpful in family planning clinic settings (Addressing Reproductive Coercion in Health Settings (ARCHES), NCT01459458). Summary score based on patient responses on an after-visit exit survey inquiring about what elements of the intervention the provider discussed during clinic visit

Secondary Outcomes

  • Difference in pregnancy risk(baseline to 4 months)
  • Change in self-efficacy to enact harm reduction behaviors (mean score)(Baseline to 4 months)
  • Enacting harm reduction behaviors (summary score)(4 months)
  • Change in knowledge of sexual and partner violence related services from baseline to follow up(Baseline to 4 months)
  • Any use of sexual and partner violence related services(4 months)
  • Change in violence victimization from baseline to follow up(Baseline to 4 months)

Study Sites (1)

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