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Clinical Trials/NCT06318663
NCT06318663
Completed
Not Applicable

Survivor Moms' Companion: A Perinatal PTSD Program

State University of New York at Buffalo1 site in 1 country39 target enrollmentDecember 12, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Posttraumatic Stress Symptom
Sponsor
State University of New York at Buffalo
Enrollment
39
Locations
1
Primary Endpoint
Adverse Childhood Experiences Questionnaire
Status
Completed
Last Updated
last year

Overview

Brief Summary

The overall goal of the SMC is to help reduce posttraumatic stress symptomology for pregnant persons with a history of trauma.

Detailed Description

The study is a pilot randomized waitlist-controlled trial that examines the preliminary efficacy of the SMC for reducing PTSD symptomology as compared to a waitlist control group. Also, it aims to assess the feasibility and acceptability of the SMC. It examines how changes in the theorized mechanisms (emotion regulation, interpersonal sensitivity) mediate the relationship between the intervention and PTSD symptomology.

Registry
clinicaltrials.gov
Start Date
December 12, 2023
End Date
November 11, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ogechi Christine Kalu

Principal Investigator

State University of New York at Buffalo

Eligibility Criteria

Inclusion Criteria

  • English- or Spanish-speaking
  • Currently pregnant or in the postpartum period
  • Age 18 and older
  • A history of trauma and PTSD
  • Able to comprehend the study protocol and consent form and provide verbal consent and
  • able to commit to a minimum of 4 weekly intervention sessions.

Exclusion Criteria

  • Non-English or non-Spanish-speaking,
  • less than 18 years of age,
  • those with psychotic conditions or developmental disabilities requiring guardianship,
  • those with high-risk pregnancies necessitating extended bedrest or inpatient care, and
  • those unable to commit to completing the intervention sessions.

Outcomes

Primary Outcomes

Adverse Childhood Experiences Questionnaire

Time Frame: This will be administered prior to the intervention as part of the starting assessment.

Scale to assess the presence of childhood trauma. If the Adverse childhood experience score is 1-3 without Adverse Childhood Experience, the responder is at "intermediate risk" for toxic stress. If the Adverse childhood experience score is 1-3 and there is the likelihood of at least one Adverse childhood experience-associated condition, or if the Adverse childhood experiences score is 4 or higher, the responder is at "high risk" for toxic stress.

Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders

Time Frame: This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.

Scale to assess presence of post-traumatic stress symptoms. Severity can be determined adding scores of each item together to determine a total score. A total score of 33 or higher may indicate severe post-traumatic stress disorder.

Childhood Trauma Questionnaire

Time Frame: This will be administered prior to the intervention as part of the starting assessment.

For eligibility screening we will use the 5 sentinel items from the Childhood Trauma Questionnaire. The higher the score is, the greater the severity of abuse for that scale. There are four categories of severity for each trauma type: None (minimal); Low (to Moderate); Moderate (to Severe); and Severe (to Extreme).

Primary Care Post Traumatic Stress Disorder Screen for Diagnostic and Statistical Manual of Mental Disorders-5

Time Frame: This will be administered at the prior to the intervention as part of the starting assessment.

The Primary Care post-traumatic stress Screen for Diagnostic and Statistical Manual of Mental Disorders is a 5-item screen designed to identify individuals with probable post-traumatic stress disorder. Primary Care Post Traumatic Stress Disorder considered "positive" if the respondent answers "yes" to any 3 items in the questions listed in the scale.

Dissociative Subtype of Post Traumatic Stress Scale

Time Frame: This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.

Scale to assess dissociative symptoms. Each item on the measure is rated on a 5-point scale (0=Not at all; 1=Once or twice; 2=Almost every day; 3=About once a day, and 4=More than once a day). The total score can range from 0 to 32, with higher scores indicating greater severity of dissociative experiences.

Secondary Outcomes

  • Patient Health Questionnaire-9(This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.)
  • State Trait Anger Expression Inventory(This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.)
  • Symptoms Checklist-90 Revised/Interpersonal Sensitivity Subscale(This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.)
  • Difficulties in Emotion Regulation Scale Short Form(This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.)

Study Sites (1)

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