Posttraumatic Stress SymptomSMCNCT06318663
Survivor Mom Companion Comparison Study
A study testing Survivor Mom Companion in people with Posttraumatic Stress Symptom, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The overall goal of the SMC is to help reduce posttraumatic stress symptomology for pregnant persons with a history of trauma. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Posttraumatic Stress Symptom
- What is being tested?
- Survivor Mom Companion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2023to 11 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Buffalo Prenatal-Perinatal Network
Buffalo, New York, 14203
About this study
Official title: Survivor Moms' Companion: A Perinatal PTSD Program
The overall goal of the SMC is to help reduce posttraumatic stress symptomology for pregnant persons with a history of trauma.
Read the 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.
- Conditions
- Posttraumatic Stress Symptom
- Being tested
- Survivor Mom Companion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survivor Mom CompanionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Survivor Mom Companion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start12 Dec 2023
- Primary completion11 Oct 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress SymptomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ogechi Christine Kalu, State University of New York at Buffalo
- Investigators
- Mickey Sperlich, PhD, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318663
- Sponsor's protocol ID
- STUDY00007685
- Acronym
- SMC
- Status last verified
- Apr 2025
- First submitted
- 11 Mar 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12615092Prins 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.
PubMed 27170304Blevins 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.
PubMed 26606250Wolf 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.
PubMed 26603115Kroenke 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.
PubMed 11556941Spielberger CD. Professional manual for the State-Trait Anger Expression Inventory-2 (STAXI-2). Odessa,FL: Psychological Assessment Resources; 1999.
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.
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. J Psychopathol Behav Assess. 2016 Sep;38(3):443-455. doi: 10.1007/s10862-015-9529-3. Epub 2015 Nov 23.
PubMed 41522882Kelly 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.
PubMed 28480521
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivor Moms' Companion: A Perinatal PTSD Program
- ClinicalTrials.gov ID
- NCT06318663
- Acronym / sponsor ID
- SMC / STUDY00007685
- Conditions
- Posttraumatic Stress Symptom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivor Mom Companion Program | Active comparator | Other: Survivor Mom CompanionParticipants 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 | Other: Survivor Mom CompanionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survivor Mom CompanionWeekly 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. | Other | Survivor Mom Companion Program, Waitlist Control |
Primary outcome
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.
4 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Background: PubMed 12615092Bernstein 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.
- Background: PubMed 27170304Prins 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.
- Background: PubMed 26606250Blevins 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.
- Background: PubMed 26603115Wolf 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.
- Background: PubMed 11556941Kroenke 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.
- BackgroundSpielberger CD. Professional manual for the State-Trait Anger Expression Inventory-2 (STAXI-2). Odessa,FL: Psychological Assessment Resources; 1999.
- BackgroundDerogatis 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: PubMed 41522882Kaufman 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. J Psychopathol Behav Assess. 2016 Sep;38(3):443-455. doi: 10.1007/s10862-015-9529-3. Epub 2015 Nov 23.
- Background: PubMed 28480521Kelly 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mickey Sperlich, PhD principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survivor Mom Companion in people with Posttraumatic Stress Symptom, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childhood Trauma Questionnaire (time frame: This will be administered prior to the intervention as part of the starting assessment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06318663, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.