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Behavioural Intervention

Survivor Mom Companion Program for Posttraumatic Stress Disorder (SMC Trial)

N/A

Recruiting

Led By Mickey Sperlich, PhD

Research Sponsored by State University of New York at Buffalo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

SMC Trial Summary

This trial aims to help pregnant individuals who have experienced trauma to reduce their symptoms of posttraumatic stress.

Who is the study for?

This trial is for pregnant individuals with a history of trauma who are experiencing symptoms of posttraumatic stress disorder (PTSD).Check my eligibility

What is being tested?

The study is testing the 'Survivor Mom Companion' program, which aims to help reduce PTSD symptoms in pregnant persons with past trauma.See study design

What are the potential side effects?

Since this intervention involves a support program rather than medication, traditional side effects are not expected. However, discussing traumatic experiences may cause emotional discomfort.

SMC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.

This trial's timeline: 3 weeks for screening, Varies for treatment, and this will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Childhood Experiences Questionnaire

Childhood Trauma Questionnaire

Dissociative Subtype of Post Traumatic Stress Scale

+2 more

Secondary outcome measures

Difficulties in Emotion Regulation Scale Short Form

Patient Health Questionnaire-9

State Trait Anger Expression Inventory

+1 more

SMC Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Survivor Mom Companion ProgramActive Control1 Intervention

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.

Group II: Waitlist ControlPlacebo Group1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor

247 Previous Clinical Trials

49,472 Total Patients Enrolled

Mickey Sperlich, PhDPrincipal InvestigatorState University of New York at Buffalo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals involved in this medical study?

"Indeed, as per the details on clinicaltrials.gov, this research investigation is actively seeking suitable candidates. The trial was originally posted on December 12th, 2023 and underwent its most recent revision on March 15th, 2024. It aims to recruit a total of 60 participants from one designated site."

Answered by AI

Are individuals currently being enrolled in this trial?

"Indeed, the details obtained from clinicaltrials.gov indicate that this research study is actively seeking volunteers. The trial was initially listed on December 12th, 2023 and most recently revised on March 15th, 2024. Researchers aim to recruit a total of 60 participants at one location."

Answered by AI

What specific objectives does this medical study aim to fulfill?

"The primary goal of this examination, which will take approximately 5 minutes to complete, is to assess the Dissociative Subtype of Post Traumatic Stress Scale (DSPS). The secondary endpoints involve evaluating the Difficulties in Emotion Regulation Scale Short Form. This tool covers various aspects such as emotional awareness and understanding, acceptance of emotions, and the capacity for purposeful behavior. Higher scores on any subscale indicate more significant challenges with managing emotions. Additionally, other measures include the Patient Health Questionnaire-9 used for screening depression severity and the State Trait Anger Expression Inventory designed to gauge anger experience and regulation control."

Answered by AI

Recent research and studies

Journal of General Internal MedicineJournal

The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5): Development and Evaluation Within a Veteran Primary Care Sample

Prins, Annabel, Michelle J. Bovin, Derek J. Smolenski, Brian P. Marx, Rachel Kimerling, Michael A. Jenkins-Guarnieri, Danny G. Kaloupek, et al.. 2016. “The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5): Development and Evaluation Within a Veteran Primary Care Sample”. Journal of General Internal Medicine. Springer Science and Business Media LLC. doi:10.1007/s11606-016-3703-5.

dsm-5Journal

The Posttraumatic Stress Disorder Checklist for <i>dsm-5</i> (PCL-5): Development and Initial Psychometric Evaluation

Blevins, Christy A., Frank W. Weathers, Margaret T. Davis, Tracy K. Witte, and Jessica L. Domino. 2015. “The Posttraumatic Stress Disorder Checklist for dsm-5 (PCL-5): Development and Initial Psychometric Evaluation”. Journal of Traumatic Stress. Wiley. doi:10.1002/jts.22059.

clinicaltrials.govStudy

Survivor Mom Companion Comparison Study

Ogechi Christine Kalu 2023. "Survivor Mom Companion Comparison Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06318663.