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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)
Must not have
Having a disability affecting communication, such as deafness
Having current symptoms or diagnosis of psychosis as defined by the DSM-5 in the past year (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

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can read, write, and speak in English or Spanish.
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I have been diagnosed with PTSD, with or without depression.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a disability that affects my ability to communicate.
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I have been diagnosed with or shown symptoms of psychosis in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow-up after treatment completion (six-months after end of treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and follow-up after treatment completion (six-months after end of treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Center for Epidemiological Studies-Depression (CES-D)
Dyadic Parent-Child Interaction Coding System-IV (DPICS)
Family Preservation Services Usual Care (FPSUC) reports
+3 more
Secondary study objectives
Adult Adolescent Parenting Inventory-2.1 (AAPI-2.1)
Difficulties in Emotion Regulation Scale (DERS)
Strengths and Difficulties Questionnaire (SDQ)
+3 more

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.

Find a Location

Who is running the clinical trial?

New York UniversityLead Sponsor
234 Previous Clinical Trials
313,735 Total Patients Enrolled
Michael A LindseyPrincipal InvestigatorNew York University

Media Library

P-STAIR (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04752618 — N/A
Post-Traumatic Stress Disorder Research Study Groups: P-STAIR, Supportive Counseling
Post-Traumatic Stress Disorder Clinical Trial 2023: P-STAIR Highlights & Side Effects. Trial Name: NCT04752618 — N/A
P-STAIR (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04752618 — N/A
~37 spots leftby Sep 2025
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