Clinical trial NCT02782728: Trauma-informed Personalized Scripts (TIPS) for Relationship Abuse
Official title: Trauma-informed Personalized Scripts (TIPS) to Address Relationship Abuse and Reproductive Coercion in Family Planning Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Violence
Abuse
Keywords: intimate partner violence
reproductive coercion
women's health
relationship abuse
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 240
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Female
* 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.

Primary outcomes:
measure: Quality of intervention delivery by provider
timeFrame: Immediately following clinic visit
Secondary outcomes:
measure: Difference in pregnancy risk
timeFrame: baseline to 4 months
measure: Change in self-efficacy to enact harm reduction behaviors (mean score)
timeFrame: Baseline to 4 months
measure: Enacting harm reduction behaviors (summary score)
timeFrame: 4 months
measure: Change in knowledge of sexual and partner violence related services from baseline to follow up
timeFrame: Baseline to 4 months
measure: Any use of sexual and partner violence related services
timeFrame: 4 months
measure: Change in violence victimization from baseline to follow up
timeFrame: Baseline to 4 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Elizabeth Miller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.