Trauma-informed Personalized Scripts (TIPS) for Relationship Abuse

Violence Clinical Trial

— TIPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782728
• Other study ID #: PRO15080163-02
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2018

Study information

• Verified date: April 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abuse
• Violence

Intervention

Behavioral:
• TIPS-Plus
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-Basic
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.

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in pregnancy risk	2.1 Change in condom use frequency: Assessment of pregnancy risk reduction through change in frequency of self-reported condom use from baseline to follow-up 2.2 Contraceptive use: Assessment of pregnancy risk reduction through differences in contraceptive use from baseline to follow-up	baseline to 4 months
Secondary	Change in self-efficacy to enact harm reduction behaviors (mean score)	Baseline-adjusted differences in mean post-intervention levels of self-efficacy regarding uptake of harm reduction strategies up to 4 months after baseline clinical encounter	Baseline to 4 months
Secondary	Enacting harm reduction behaviors (summary score)	Summary score of use of any harm reduction strategies, measured by investigator developed items that include a range of harm reduction strategies that women may employ to increase their safety	4 months
Secondary	Change in knowledge of sexual and partner violence related services from baseline to follow up	Knowing about specified IPV/SV related services comparing baseline and follow up summary scores	Baseline to 4 months
Secondary	Any use of sexual and partner violence related services	Any use of sexual violence related services (summary score) at 4 month follow up	4 months
Secondary	Change in violence victimization from baseline to follow up	Among those reporting exposure to violence (IPV/SV/RC) at baseline, summary score of any recent (past 3 months) violence victimization (including IPV/SV/RC), comparing before intervention to after the intervention	Baseline to 4 months