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Behavioral Intervention
Combined Therapies for Maternal PTSD (SMSC Trial)
N/A
Recruiting
Led By Michael A Lindsey
Research Sponsored by New York University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Being able to read, write, and speak English or Spanish
Meeting DSM-5 diagnostic criteria for PTSD (CAPS-5) with or without co-occurring depression (SCID-5)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion
Awards & highlights
SMSC Trial Summary
This trial will test whether a combination of therapies can help reduce maternal PTSD and the likelihood of maltreatment happening again.
Who is the study for?
This trial is for mothers with PTSD, possibly also depression, who can communicate in English or Spanish and have a child aged 1-8. They must be receiving preventive services, have custody of their child, and meet specific criteria for PTSD severity. Those with recent suicidal thoughts or attempts, psychosis symptoms or diagnosis, substance abuse issues, communication disabilities like deafness, children with developmental conditions impeding function (e.g., autism), or current/recent intimate partner violence are excluded.Check my eligibility
What is being tested?
The 'Safe Mothers, Safe Children Initiative' tests the effectiveness of P-STAIR—a combination of Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Interaction Therapy (PCIT)—in treating maternal PTSD and preventing child maltreatment recurrence.See study design
What are the potential side effects?
While not explicitly stated here, interventions like P-STAIR may lead to emotional discomfort due to discussing traumatic experiences during therapy sessions. There might also be temporary increases in distress as new coping strategies are learned.
SMSC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can read, write, and speak in English or Spanish.
Select...
I have been diagnosed with PTSD, with or without depression.
SMSC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ follow-up after treatment completion (six-months after end of treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow-up after treatment completion (six-months after end of treatment)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Center for Epidemiological Studies-Depression (CES-D)
Dyadic Parent-Child Interaction Coding System-IV (DPICS)
Family Preservation Services Usual Care (FPSUC) reports
+3 moreSecondary outcome measures
Adult Adolescent Parenting Inventory-2.1 (AAPI-2.1)
Children's Behavior Questionnaire - Very Short Form (CBQ-VSF)
Post-Traumatic Stress Disorder
+7 moreSMSC Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: P-STAIRExperimental Treatment1 Intervention
Participants will receive 23 weekly individual treatment sessions. Each session will last one hour. P-STAIR is a combination of STAIR and PCIT. STAIR focuses on reduction of PTSD symptoms through enhancement of emotion regulation skills. PCIT focuses on the reduction of negative parenting skills and the increase of positive parenting skills.
Group II: Supportive CounselingActive Control1 Intervention
Participants will receive 23 weekly individual treatment sessions. Each session will last one hour. Supportive counseling has been modified to permit non-trauma discussion of parenting problems. Each session is client-directed and clinicians take an unconditionally supportive role.
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Who is running the clinical trial?
New York UniversityLead Sponsor
226 Previous Clinical Trials
313,957 Total Patients Enrolled
Michael A LindseyPrincipal InvestigatorNew York University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a child between 1 and 8 years old.Your child has been diagnosed with or has shown symptoms of psychosis in the past three months.I am currently receiving preventive health services.I have a disability that affects my ability to communicate.I can read, write, and speak in English or Spanish.I have been diagnosed with or shown symptoms of psychosis in the last year.You have had thoughts about hurting yourself or have attempted suicide within the past year.You have a child with a developmental condition that affects their thinking or physical abilities, like autism.I have been diagnosed with PTSD, with or without depression.I have a history of intimate or family violence but have been safe for the required time.You have a high score on a test that measures the severity of your symptoms, or you meet the diagnostic criteria for post-traumatic stress disorder (PTSD) according to the latest guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: P-STAIR
- Group 2: Supportive Counseling
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial accepting participants who are of legal age?
"The eligibility criteria of this research requires that patients are within the 18 to 64 year age range."
Answered by AI
Is there availability for participants in this experiment?
"Confirmed. The information available on clinicaltrials.gov indicates that recruitment for this medical trial is presently ongoing, which was initially published on May 1st 2021 and has been modified most recently on July 15th 2022. A total of 220 individuals are being sought out from one location."
Answered by AI
What is the goal of this research initiative?
"The primary goal of this trial, measured over a period from pre-treatment to mid-treatment at session 16 and upon completion of treatment (on average 43 weeks) through six months post-treatment is the reduction of new child abuse/neglect welfare reports. As secondary outcomes, Strengths and Difficulties Questionnaire (SDQ), Post-traumatic Stress Diagnostic Scale for the DSM-5 (PDS–5) and Eyberg Child Behavior Inventory (ECBI) will be utilized during the course of intervention in order to assess changes in behavior between parent–child dyadic play observations as well as frequency and severity level of"
Answered by AI
Who is eligible to participate in this medical research experiment?
"This trial is currently accepting participants who have been diagnosed with depression and are within the 18-64 age range. The full roster features 220 members in total."
Answered by AI
What is the cap on patient participation in this research endeavor?
"Affirmative. Information on clinicaltrials.gov verifies that this medical trial, which was first posted on May 1st 2021, is actively seeking participants. Approximately 220 individuals need to be recruited from a single site."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
Maryland
New York
How old are they?
18 - 65
What site did they apply to?
McSilver Institute for Poverty Policy and Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
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