Survivor Mom Companion Comparison Study

NCT06318663 | Completed

• 1 other identifier: STUDY00007685
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Posttraumatic Stress Symptom

Outcome Measures

Primary Outcomes (5)

• Childhood Trauma Questionnaire

  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).

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

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

  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.

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

• Adverse Childhood Experiences Questionnaire

  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.

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

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

  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.

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

• Dissociative Subtype of Post Traumatic Stress Scale

  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.

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

Secondary Outcomes (4)

• 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 Arms (2)

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.

Other: Survivor Mom Companion

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.

Other: Survivor Mom Companion

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.

Survivor Mom Companion Program; Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants will self-identify.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Buffalo Prenatal-Perinatal Network

Buffalo, New York, 14203, United States

Location

Related Publications (9)

• Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Stokes J, Handelsman L, Medrano M, Desmond D, Zule W. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl. 2003 Feb;27(2):169-90. doi: 10.1016/s0145-2134(02)00541-0.

  PMID: 12615092 BACKGROUND

• Prins A, Bovin MJ, Smolenski DJ, Marx BP, Kimerling R, Jenkins-Guarnieri MA, Kaloupek DG, Schnurr PP, Kaiser AP, Leyva YE, Tiet QQ. The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5): Development and Evaluation Within a Veteran Primary Care Sample. J Gen Intern Med. 2016 Oct;31(10):1206-11. doi: 10.1007/s11606-016-3703-5. Epub 2016 May 11.

  PMID: 27170304 BACKGROUND

• Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.

  PMID: 26606250 BACKGROUND

• Wolf EJ, Mitchell KS, Sadeh N, Hein C, Fuhrman I, Pietrzak RH, Miller MW. The Dissociative Subtype of PTSD Scale: Initial Evaluation in a National Sample of Trauma-Exposed Veterans. Assessment. 2017 Jun;24(4):503-516. doi: 10.1177/1073191115615212. Epub 2015 Nov 23.

  PMID: 26603115 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Spielberger CD. Professional manual for the State-Trait Anger Expression Inventory-2 (STAXI-2). Odessa,FL: Psychological Assessment Resources; 1999.

  BACKGROUND

• Derogatis LR, Lipman RS, Covi L. SCL-90. Administration, scoring and procedures manual-I for the R (revised) version and other instruments of the Psychopathology Rating Scales Series. Chicago: Johns Hopkins University School of Medicine; 1977.

  BACKGROUND

• Kaufman EA, Xia M, Fosco G, Yaptangco M, Skidmore CR, Crowell SE. The Difficulties in Emotion Regulation Scale Short Form (DERS-SF): Validation and replication in adolescent and adult samples. Journal of Psychopathology and Behavioral Assessment. 2016 Sep;38(3):443-55. doi: 10.1007/s10862-015-9529-3

  BACKGROUND

• Kelly PJ, Kyngdon F, Ingram I, Deane FP, Baker AL, Osborne BA. The Client Satisfaction Questionnaire-8: Psychometric properties in a cross-sectional survey of people attending residential substance abuse treatment. Drug Alcohol Rev. 2018 Jan;37(1):79-86. doi: 10.1111/dar.12522. Epub 2017 May 7.

  PMID: 28480521 BACKGROUND

Study Officials

• Mickey Sperlich, PhD

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 19, 2024
• Study Start: December 12, 2023
• Primary Completion: October 11, 2024
• Study Completion: November 11, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)