MedDataX Logo

Parenting STAIR: Adapting a Trauma-Focused Parenting Intervention for Military-Connected Mothers and Their Children

NCT ID: NCT06262178

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-21

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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, and 4) have assessments audio and video recorded.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The present study is a two-arm randomized controlled trial (RCT) conducted in a community mental health setting comparing Parenting STAIR Modular (PSTAIR-M), and treatment as usual (TAU). This study will enroll N=120 military-connected mothers (MCM) and one index child (aged 2-10) at three Cohen Veterans Network (CVN) clinics (Family Endeavors Clinics in El Paso, Killeen, and San Antonio, TX). Participants will be trauma-exposed MCM who screen positive for PSTD and/or depression and/or demonstrate low parenting self-efficacy, and one identified child (ages 2-10). MCM will be randomly assigned to either PSTAIR-M (N=80 mothers; 80 children) or treatment-as-usual (TAU; N=40 mothers; 40 children). PSTAIR-M and TAU will be delivered virtually by CVN clinicians.

Parenting STAIR (PSTAIR) combines two existing evidence-based treatments (EBT), Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Care (PC-CARE). PSTAIR-M involves a compact version of PSTAIR in Module 1 and tailored options for Module 2, focusing on skills development (Module 2a), narrative exposure (Module 2b), or parental functioning (Module 2c), implemented based on response to Module 1.

Assessments will occur at three timepoints: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 weeks after baseline). Assessments will include self-report instruments and dyadic parenting observations.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

PTSD Depression Parent-Child Relations

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parenting STAIR Modular (PSTAIR-M) is a 12 to 16-week intervention depending on the Modules selected for each individual participant. All participants receiving PSTAIR-M will receive Module 1. Module 1 is 11 sessions long and consists of five sessions focused on emotional regulation skill development, three focused on narrative exposure, and three involving dyadic parent coaching. Following Module 1, participants will complete the mid-treatment assessment; scores on this assessment will inform a shared decision-making session in which participants and clinicians will determine whether clients can proceed directly to a final termination session or if clients will continue on to Module 2. In Module 2, clients will receive three more sessions focused on skill development (2a), narrative exposure (2b), or parenting (2c).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Assessors will be blind to treatment arm. Coders blind to treatment arm will also code 10% of dyadic parenting sessions.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Parenting-STAIR Modular (PSTAIR-M)

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Parenting-STAIR Modular (PSTAIR-M)

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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)).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cohen Veterans Network

UNKNOWN

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role collaborator

New York University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kathrine S Sullivan, PhD

Role: PRINCIPAL_INVESTIGATOR

New York University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

El Paso, Texas, United States

Site Status RECRUITING

Steven A. Cohen Military Family Clinic at Endeavors, Killeen

Killeen, Texas, United States

Site Status RECRUITING

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

San Antonio, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kathrine S Sullivan, PhD

Role: CONTACT

Phone: 3235526056

Email: [email protected]

Gina M Angelotti, MPH

Role: CONTACT

Phone: 6462671807

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gina Angelotti, MPH

Role: primary

Kathrine Sullivan, PhD, MSW

Role: backup

Gina Angelotti, MPH

Role: primary

Kathrine Sullivan, PhD, MSW

Role: backup

Gina Angelotti, MPH

Role: primary

Kathrine Sullivan, PhD, MSW

Role: backup

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

23-1393

Identifier Type: -

Identifier Source: org_study_id