What this study is
The goal of this study is to assess Parenting STAIR Modular (PSTAIR-M), a promising and innovative intervention for military-connected mothers (MCM) who have experienced trauma and their young children (ages 2-10). PSTAIR-M aims to help mothers manage the strong feelings that sometimes happen after experiencing something scary or stressful, as well as to better connect with their children and manage their behavior effectively.
The main questions the study aims to answer are: from pre-treatment to post-treatment 1) Does PSTAIR-M reduce maternal PTSD and/or depression symptoms?, and 2) Does PSTAIR-M improve parental functioning?
Participants will: 1) attend 12-16 weekly, 1-hour online treatment sessions with their assigned clinicians, 2) complete three 1-hour online assessments administered by research staff, 3) engage with their child in three 15-30-minute online, observed play sessions, 4) have assessments and observed play sessions audio and video recorded.
Participants may also be invited to participate in an optional, 30-minute online one-on-one qualitative interview, which would be audio and video recorded and would cover participants' experiences with the intervention, the clinic sites, and their providers.
What's being tested
- Parenting-STAIR Modular (PSTAIR-M)
Intervention · BEHAVIORAL
12-16 PSTAIR-M treatment sessions (approximately 12-16 weeks).
Study details
- Sponsor
- New York University
- Conditions
- PTSD · Depression · Parent-Child Relations
- Enrolling
- 120 people
- Starts
- 2025-07-21
- Est. completion
- 2027-09-30
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Military-connected mother, defined as a mother who is either a female service member or veteran or female spouse of a service member or veteran;
- Has a child aged 2-10;
- Legal guardian of index child with legal and physical custody;
- Lifetime trauma exposure (Life Events Checklist (LEC-5); Adverse Childhood Experiences Questionnaire (ACE-Q));
- Screen positive for PTSD (defined as a PCL-5 score ≥32 or meeting ≥3 out of 4 DSM-5 symptom criteria [B, C, D, E] on the PCL-5), and/or depression (PHQ-9 score ≥8), and/or low parenting self-efficacy (PSOC score <59);
- Able to speak and understand English or Spanish;
- Eligible to receive services at a Steven A. Cohen Military Family Clinic at Endeavors.
You can't join if
- High risk for suicide (Ask Suicide-Screening Questions (ASQ));
- Current psychotic symptoms (DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure Domain VII);
- Disability affecting communication, such as deafness;
- Index child with severe developmental disability;
- Severe substance or alcohol use (The Alcohol, Smoking and Substance Involvement Screening Test - Lite (ASSIST-Lite); Cannabis Use Disorder Identification Test-Short Form (CUDIT-SF));
- Currently receiving another trauma-focused individual mental health treatment.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openContact for every open site
- Gina Angelotti, MPH · Contact915-213-6653ga2208@nyu.edu
- Kathrine Sullivan, PhD, MSW · Contact915-213-6653ks5313@nyu.edu
Steven A. Cohen Military Family Clinic at Endeavors, El Paso
El Paso, Texas, United States
RecruitingSteven A. Cohen Military Family Clinic at Endeavors, Killeen
Killeen, Texas, United States
RecruitingSteven A. Cohen Military Family Clinic at Endeavors, San Antonio
San Antonio, Texas, United States
Recruiting
Study team
Sponsor
New York University
Study ID 23-1393
Principal investigator
Kathrine S Sullivan, PhD
New York University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.