Recruiting

PSTAIR-M

Sponsor:

New York University

Code:

NCT06262178

Conditions

PTSD

Depression

Parent-Child Relations

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Parenting-STAIR Modular (PSTAIR-M)

Treatment as Usual (TAU)

Study Details

Brief summary:

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: 1) Does PSTAIR-M reduce maternal PTSD and/or depression symptoms?, and 2) Does PSTAIR-M improve parental functioning?

Researchers will compare PSTAIR-M to treatment as usual (TAU) - other EBTs offered at participating study sites - to determine if PSTAIR-M is more effective in improving mental health and parenting.

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.

Conditions

PTSD

Depression

Parent-Child Relations

Study ID

NCT06262178

Start date

Jul 21, 2025

Status verified date

Oct, 2025

Completion date

Sep 30, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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;
2. Has a child aged 2-10;
3. Legal guardian of index child with legal and physical custody;
4. Lifetime trauma exposure (Life Events Checklist (LEC-5); Adverse Childhood Experiences Questionnaire (ACE-Q));
5. 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);
6. Able to speak and understand English or Spanish;
7. Eligible to receive services at a Steven A. Cohen Military Family Clinic at Endeavors.

Exclusion Criteria:

1. High risk for suicide (Ask Suicide-Screening Questions (ASQ));
2. Current psychotic symptoms (DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure Domain VII);
3. Disability affecting communication, such as deafness;
4. Index child with severe developmental disability;
5. 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));
6. Currently receiving another trauma-focused individual mental health treatment.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Parenting STAIR Modular (PSTAIR-M)

PSTAIR-M is a culturally adapted, 12-16-session modular intervention which combines elements of two existing EBTs: Skills Training in Affective and Interpersonal Regulation (STAIR), targeting maternal trauma and emotion dysregulation, and dyadic Parent-Child Care (PC-CARE), targeting parenting.

active comparator: Treatment as Usual (TAU)

Treatment as usual (TAU) is defined as an established EBT that is already being delivered at the study sites on an ongoing basis. Possible EBTs include prolonged exposure, cognitive processing therapy, cognitive behavioral therapy, and emotion-focused therapy. Clinicians treating participants randomly assigned to TAU will determine the most appropriate course of treatment based on established clinic protocols for treatment assignment.

Interventions

Parenting-STAIR Modular (PSTAIR-M)

12-16 PSTAIR-M treatment sessions (approximately 12-16 weeks).

Treatment as Usual (TAU)

Weekly treatment sessions of an established EBT. The total number of sessions/weeks will be determined by the EBT and clinic protocols.

Primary outcome measure

  • Post-traumatic stress disorder (PTSD) Checklist 5 [ Time Frame: PCL-5 will be administered at three assessment timepoints: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 weeks after baseline). ]
  • Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: PHQ-9 will be administered at three assessment timepoints: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 weeks after baseline). ]
  • Parenting Sense of Competence Scale (PSOC) [ Time Frame: PSOC will be administered at three assessment timepoints: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 weeks after baseline). ]

Central Contacts and Locations

Central contacts

Kathrine S Sullivan, PhD

3235526056ks5313@nyu.edu

Gina M Angelotti, MPH

6462671807ga2208@nyu.edu

Locations

Steven A. Cohen Military Family Clinic at Endeavors, El Paso

Recruiting

El Paso, Texas, United States, 79936

Contacts

Gina Angelotti, MPH

915-213-6653ga2208@nyu.edu

Kathrine Sullivan, PhD, MSW

915-213-6653ks5313@nyu.edu

Steven A. Cohen Military Family Clinic at Endeavors, Killeen

Recruiting

Killeen, Texas, United States, 76549

Contacts

Gina Angelotti, MPH

915-213-6653ga2208@nyu.edu

Kathrine Sullivan, PhD, MSW

915-213-6653ks5313@nyu.edu

Steven A. Cohen Military Family Clinic at Endeavors, San Antonio

Recruiting

San Antonio, Texas, United States, 78249

Contacts

Gina Angelotti, MPH

915-213-6653ga2208@nyu.edu

Kathrine Sullivan, PhD, MSW

915-213-6653ks5313@nyu.edu

More Information

Sponsor

New York University

Last update posted

Aug 7, 2026

Last verified

Oct, 2025

Keywords

  • PTSD
  • Depression
  • STAIR
  • PC-CARE
  • Parenting
  • Parent-Child Relations
  • Military Family

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by New York University on 2026-08-07.