---
title: Survivor Mom Companion Comparison Study
nct_id: NCT06318663
overall_status: COMPLETED
phase: NA
sponsor: State University of New York at Buffalo
study_type: INTERVENTIONAL
primary_condition: Posttraumatic Stress Symptom
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06318663.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06318663"
ct_last_update_post_date: 2025-04-09
last_seen_at: "2026-05-12T07:25:38.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Survivor Mom Companion Comparison Study

**Official Title:** Survivor Moms' Companion: A Perinatal PTSD Program

**NCT ID:** [NCT06318663](https://clinicaltrials.gov/study/NCT06318663)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 39
- **Lead Sponsor:** State University of New York at Buffalo
- **Conditions:** Posttraumatic Stress Symptom
- **Start Date:** 2023-12-12
- **Completion Date:** 2024-11-11
- **CT.gov Last Update:** 2025-04-09

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Survivor Mom Companion Program** (ACTIVE_COMPARATOR) — Participants in the Survivor Moms' Companion intervention will complete a minimum of 4 Survivor Moms' Companion psychoeducational modules with weekly tutor support and will then complete an ending assessment. Sessions with tutors are conducted over the phone or in person at the Buffalo Prenatal and Perinatal Network and last for 45 minutes.
- **Waitlist Control** (PLACEBO_COMPARATOR) — Participants in the waitlist control group will complete the baseline assessment over the phone, wait six weeks, and then complete the ending assessment. Those on the waitlist will then be offered the Survivor Moms' Companion intervention. Sessions with tutors are conducted over the phone or in person at the Buffalo Prenatal and Perinatal Network and last for 45 minutes.

## Interventions

- **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

- **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.
- **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.
- **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** _(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.)_
- **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.)_
- **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.)_
- **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.)_

## Locations (1)

- Buffalo Prenatal-Perinatal Network, Buffalo, New York, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.buffalo prenatal-perinatal network|buffalo|new york|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06318663.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06318663*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*