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NCT06654427

Trauma-Informed Obstetric Care: Development and Implementation of a Toolkit for Obstetrics (OBTIC)

Enrolling by Invitation
NAAges 18–99InterventionalHealth services
The Miriam Hospital
~165 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:Obstetric Trauma Informed Care Toolkit

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluation of intervention components for adaptation and scale-up implementation
Measured over Surveys to evaluate specific components of the OB-TIC toolkit will be given in early implementation (2-3 months)
+4 more outcomes measured

Conditions

Trauma
Obstetrics Trauma
Pregnancy Related

Explore related trials

InjuryPostpartum StatePregnancy

Where it's being run

1 sites across 1 states
Rhode Island1

Study leadership

  • Laura G Ward, Ph.D. · PRINCIPAL_INVESTIGATOR · The Miriam Hospital

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

≥ 18 years old
under the care of an obstetrician or nurse practitioner in the U.S.,
English-speaking
have had ≥2 prenatal care encounters, and postpartum if they delivered a surviving infant within the past 12 months
received care at either of the pilot sites during the pilot trial.
Pregnant and postpartum participants will be eligible for the trauma-exposed group if they
report a history of trauma in childhood or adulthood,
are ≥1 year from the time of the traumatic experience
are not currently at-risk for harm from self or others
are willing to discuss experiences related to trauma and are able to do so without experiencing undue distress.
Patient participants will be eligible for the non-trauma group if they deny trauma.
Practicing physicians or nurses
≥ 6 months of experience in obstetrics
English speaking
Clinician Participants (providers in the participating clinics) will be enrolled in the pilot trial of the obstetric trauma-informed care toolkit intervention.
Clinician participants will be enrolled for group or individual interviews if they consent to do so and meet above criteria.

Exclusion

a current unsafe environment (determined by the Assessment of Immediate Safety)
report suicidal ideation (as determined by the PHQ9)
report difficulty discussing experiences related to trauma.

What this trial measures

  • Evaluation of intervention components for adaptation and scale-up implementationSurveys to evaluate specific components of the OB-TIC toolkit will be given in early implementation (2-3 months)

    Once the OB-TIC toolkit is complete, I will work with my mentorship team to create a survey to assess the most frequently used components of the toolkit. For example, if OB-TIC includes trauma-informed birth strategies, mental health referrals, and a modified exam procedure checklist, the survey would list each of these components and ask clinicians how often each component was used, rate how useful the component was, and whether they made changes to any of the materials.

  • Evaluation of intervention components for adaptation and scale-up implementationSurveys to evaluate specific components of the OB-TIC toolkit will be given in sustainment (6-12 months)

    Once the OB-TIC toolkit is complete, I will work with my mentorship team to create a survey to assess the most frequently used components of the toolkit. For example, if OB-TIC includes trauma-informed birth strategies, mental health referrals, and a modified exam procedure checklist, the survey would list each of these components and ask clinicians how often each component was used, rate how useful the component was, and whether they made changes to any of the materials.

  • Change in Acceptability of Intervention MeasureClinicians are given the survey in early implementation (2-3 months) and sustainment (6-12 months)

    Clinicians will rate acceptability on a 5-point ordinal scale ranging from "completely disagree" to "completely agree". The measure consists of 4 items and has a test-retest reliability Cronbach alpha of .83.

  • Change in Intervention Appropriateness MeasureClinicians are given the survey in early implementation (2-3 months) and sustainment (6-12 months)

    Clinicians will rate appropriateness on a 5-point ordinal scale ranging from "completely disagree" to "completely agree". The measure consists of 4 items and has a test-retest reliability Cronbach alpha of .87.

  • Change in Feasibility of Intervention MeasureClinicians are given the survey in early implementation (2-3 months) and sustainment (6-12 months)

    Clinicians will rate feasibility on a 5-point ordinal scale ranging from "completely disagree" to "completely agree". The measure consists of 4 items and has a test-retest reliability Cronbach alpha of .88.