Trauma-informed Personalized Scripts (TIPS) for Relationship Abuse

NCT02782728 | Completed

• 1 other identifier: PRO15080163-02
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Violence; Abuse

Keywords

intimate partner violence; reproductive coercion; women's health; relationship abuse

Outcome Measures

Primary Outcomes (1)

• Quality of intervention delivery by provider

  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

  Immediately following clinic visit

Secondary Outcomes (6)

• 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

Study Arms (2)

TIPS-Basic

ACTIVE COMPARATOR

Providers receive tailored scripts based on the patient's responses to the questions administered via tablet.

Behavioral: TIPS-Basic

TIPS-Plus

EXPERIMENTAL

Patients receive tailored messages in addition to the scripts given to providers.

Behavioral: TIPS-Plus

Interventions

TIPS-Plus BEHAVIORAL

Patients receive brief psycho-educational messages on a tablet computer following completion of questionnaire about personal experiences of intimate partner violence (IPV), sexual assault (SA), and reproductive coercion (RC). These messages are tailored to each patient and are based on their responses to specific items. The messages serve as prompts to encourage the patient to continue the discussion about various topics (healthy relationships, birth control methods, harm reduction) with their provider during their clinic visit. Simultaneously, providers receive a print out with a series of scripts tailored to the patient's responses to introduce healthy relationships education, brief counseling, and harm reduction.

TIPS-Plus

TIPS-Basic BEHAVIORAL

Patients complete tablet questionnaire about personal experiences of IPV/SA/RC and based on responses, providers receive a print out with a series of scripts tailored to the patient's responses to introduce healthy relationships education, brief counseling, and harm reduction.

TIPS-Basic

Eligibility Criteria

• Age: 16 Years - 29 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (6)

• Miller E, Decker MR, McCauley HL, Tancredi DJ, Levenson RR, Waldman J, Schoenwald P, Silverman JG. A family planning clinic partner violence intervention to reduce risk associated with reproductive coercion. Contraception. 2011 Mar;83(3):274-80. doi: 10.1016/j.contraception.2010.07.013.

  PMID: 21310291 BACKGROUND

• Miller E, Decker MR, McCauley HL, Tancredi DJ, Levenson RR, Waldman J, Schoenwald P, Silverman JG. Pregnancy coercion, intimate partner violence and unintended pregnancy. Contraception. 2010 Apr;81(4):316-22. doi: 10.1016/j.contraception.2009.12.004. Epub 2010 Jan 27.

  PMID: 20227548 BACKGROUND

• Miller E, McCauley HL, Tancredi DJ, Decker MR, Anderson H, Silverman JG. Recent reproductive coercion and unintended pregnancy among female family planning clients. Contraception. 2014 Feb;89(2):122-8. doi: 10.1016/j.contraception.2013.10.011. Epub 2013 Dec 10.

  PMID: 24331859 BACKGROUND

• Miller E, Tancredi DJ, Decker MR, McCauley HL, Jones KA, Anderson H, James L, Silverman JG. A family planning clinic-based intervention to address reproductive coercion: a cluster randomized controlled trial. Contraception. 2016 Jul;94(1):58-67. doi: 10.1016/j.contraception.2016.02.009. Epub 2016 Feb 15.

  PMID: 26892333 BACKGROUND

• Hill AL, Zachor H, Miller E, Talis J, Zelazny S, Jones KA. Trauma-Informed Personalized Scripts to Address Partner Violence and Reproductive Coercion: Follow-Up Findings from an Implementation Randomized Controlled Trial Study. J Womens Health (Larchmt). 2021 Apr;30(4):604-614. doi: 10.1089/jwh.2020.8527. Epub 2020 Nov 18.

  PMID: 33211607 DERIVED

• Hill AL, Zachor H, Jones KA, Talis J, Zelazny S, Miller E. Trauma-Informed Personalized Scripts to Address Partner Violence and Reproductive Coercion: Preliminary Findings from an Implementation Randomized Controlled Trial. J Womens Health (Larchmt). 2019 Jun;28(6):863-873. doi: 10.1089/jwh.2018.7318. Epub 2019 Apr 10.

  PMID: 30969147 DERIVED

Study Officials

• Elizabeth Miller, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Adolescent Medicine, Professor of Pediatrics

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 25, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

US (1)