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Completed

NCT Number: NCT06318663

Survivor Mom Companion Comparison Study

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Buffalo Prenatal-Perinatal Network

Buffalo, New York, 14203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Survivor Mom Companion

Other

Weekly intervention sessions will follow the survivor Moms' Companion manualized modules. One module each week. The module centers on reinforcement of information introduced in each previous module, then emotional support, and referrals to additional services or specialists as needed. Participants in each session will practice applying knowledge and skills using the module's vignettes. Process guides prompt inquiry about in vivo management of post-traumatic stress disorder reactions and emotional and interpersonal responses to events since the last session. Each module may require 45 minutes of self-study before each session and 45 minutes of in-session time spent with the interventionist.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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

  1. Patient Health Questionnaire-9

    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.

    A multipurpose instrument for screening and measuring severity of depression. In the scale 1-4 = minimal depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression and 20-27= severe depression. Thus, the higher the total score the higher the perceived level of depression.

  2. State Trait Anger Expression Inventory

    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.

    A psychometric assessment that measures the experience and control of anger. scores are classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80). A higher score signifies higher anxiety.

  3. Symptoms Checklist-90 Revised/Interpersonal Sensitivity Subscale

    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.

    Instrument help evaluate a broad range of psychological problem symptoms. Using a five-point scale ranging from "not at all" to "extremely", each item assesses the severity of distress the respondent experienced in the last 7 days. Each item is graded from 1 to 5 according to the severity (none, mild, moderate, severe and extreme). The scores of the items were regarded as extreme when the total is between 30-36.

  4. Difficulties in Emotion Regulation Scale Short Form

    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.

    Covers four dimensions of emotional regulation; awareness and understanding of emotions, acceptance of emotions and the ability to engage in goal-directed behavior. All subscales are scored so that higher values reflect greater difficulty with emotion regulation.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

Survivor Moms' Companion: A Perinatal PTSD Program

Acronym: SMC

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 19, 2024
Registry last updated
Apr 9, 2025

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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