Trauma-informed Personalized Scripts (TIPS) for Relationship Abuse

NCT ID: NCT02782728

Last Updated: 2019-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Violence Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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TIPS-Basic

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

Group Type ACTIVE_COMPARATOR

TIPS-Basic

Intervention Type 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-Plus

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

Group Type EXPERIMENTAL

TIPS-Plus

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

29 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Miller

Chief of Adolescent Medicine, Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth Miller, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21310291 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20227548 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24331859 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26892333 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33211607 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30969147 (View on PubMed)

Other Identifiers

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PRO15080163-02

Identifier Type: -

Identifier Source: org_study_id

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