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Completed

NCT Number: NCT02782728

Trauma-informed Personalized Scripts (TIPS) for Relationship Abuse

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.

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Key information

Conditions

Violence Abuse

Age range

16 year–29 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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-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.

Primary outcomes

  1. Quality of intervention delivery by provider

    Time frame: Immediately following clinic visit

    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

Secondary outcomes

  1. Difference in pregnancy risk

    Time frame: baseline to 4 months

    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

  2. Change in self-efficacy to enact harm reduction behaviors (mean score)

    Time frame: Baseline to 4 months

    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

  3. Enacting harm reduction behaviors (summary score)

    Time frame: 4 months

    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. Change in knowledge of sexual and partner violence related services from baseline to follow up

    Time frame: Baseline to 4 months

    Knowing about specified IPV/SV related services comparing baseline and follow up summary scores

  5. Any use of sexual and partner violence related services

    Time frame: 4 months

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

  6. Change in violence victimization from baseline to follow up

    Time frame: Baseline to 4 months

    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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Acronym: TIPS

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
May 25, 2016
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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