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ViolenceTIPSNCT02782728

Trauma-informed Personalized Scripts (TIPS) for Relationship Abuse

A study testing TIPS-Plus and TIPS-Basic in people with Violence and Abuse, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 16 to 29 years, women onlyHealthy volunteers can take part
Conditions the study is for
Violence, Abuse
What is being tested?
TIPS-Plus and TIPS-Basic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteUnited States
Study dates
Jun 2016to Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 29 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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

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
Being tested
TIPS-Plus, TIPS-Basic
Keywords
intimate partner violence, reproductive coercion, women's health, relationship abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TIPS-PlusBehavioural

    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-BasicBehavioural

    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.

Study groups in NCT02782728
Study groupRoleWhat they receive
TIPS-BasicActive comparatorProviders receive tailored scripts based on the patient's responses to the questions administered via tablet.
Receives: Behavioral: TIPS-Basic
TIPS-PlusExperimentalPatients receive tailored messages in addition to the scripts given to providers.
Receives: Behavioral: TIPS-Plus

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Immediately following clinic visit

Secondary outcomes (6)

  1. 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

    Measured: baseline to 4 months

  2. 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

    Measured: Baseline to 4 months

  3. 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

    Measured: 4 months

  4. 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

    Measured: Baseline to 4 months

  5. Any use of sexual and partner violence related services

    Any use of sexual violence related services (summary score) at 4 month follow up

    Measured: 4 months

  6. 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

    Measured: Baseline to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionAug 2017
  4. Study completionDec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02782728
Sponsor's protocol ID
PRO15080163-02
Acronym
TIPS
Status last verified
Apr 2019
First submitted
12 May 2016
Last updated
17 Apr 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21310291

  • 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.

    PubMed 20227548

  • 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.

    PubMed 24331859

  • 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.

    PubMed 26892333

  • 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.

    PubMed 33211607

  • 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.

    PubMed 30969147

Questions about this trial

What is this clinical trial studying?

A study testing TIPS-Plus and TIPS-Basic in people with Violence and Abuse, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of intervention delivery by provider (time frame: Immediately following clinic visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02782728, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.

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TIPS Clinical Trial NCT02782728 | AzTrials