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

NCT06262178 | Recruiting DMC

• 1 other identifier: 23-1393
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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, and 4) have assessments audio and video recorded.

Conditions

PTSD; Depression; Parent-Child Relations

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Post-traumatic stress disorder (PTSD) Checklist 5

  The PCL-5 will be used to assess severity and change in PTSD symptoms. The PCL-5 is a 20-item self-report measure with strong evidence of reliability and convergent validity. Participants indicate the degree to which they have been bothered by problems related to a traumatic experience in the past month (e.g., "repeated, disturbing dreams of the stressful experience"; "feeling very upset when something reminded you of the stressful experience") on a 5-point Likert scale (0=not at all; 1=a little bit; 2=moderately; 3=quite a bit; 4=extremely). Summed responses yield a continuous score ranging from 0 to 80; higher scores indicate greater symptom severity.

  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)

  The PHQ-9 will be used to assess severity and change in depressive symptoms. The PHQ-9 is a 9-item self-report measure with strong evidence of reliability and predictive and convergent validity. Participants indicate how often they have been bothered by particular problems within the past two weeks (e.g., "feeling down, depressed, or hopeless"; "poor appetite or overeating") on a 4-point Likert scale (0=not at all; 1=several days; 2=more than half the days; 3=nearly every day). Summed responses yield a continuous score ranging from 0 to 27; higher scores indicate greater symptom severity.

  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)

  The PSOC will be used to assess parental functioning as reflected by parenting self-efficacy. The PSOC is a 17-item self-report measure with strong evidence of reliability and validity. Participants indicate how much they agree or disagree with statements related to parenting (e.g., "Being a parent is manageable, and any problems are easily solved"; "My mother/father was better prepared than I am to be a good parent") on a 6-point Likert scale (1=strongly disagree; 2=disagree; 3=somewhat disagree; 4=somewhat agree; 5=agree; 6=strongly agree). Summed responses yield a continuous score ranging from 17 to 102; higher scores indicate greater parenting competency.

  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).

Secondary Outcomes (6)

• Difficulties in Emotion Regulation Scale (DERS)

  DERS 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).

• Brief Cope

  Brief Cope 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).

• Dyadic Parent-Child Interaction Coding System-IV (DPICS)

  DPICS-IV observation will occur at three time points: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 weeks after baseline).

• Treatment Acceptability and Expectations (TAE)

  The TAE will be administered at two time points: mid-treatment (after session 11, approximately 11 weeks after baseline) and post-treatment (approximately 17 weeks after baseline).

• Strengths and Difficulties Questionnaire (SDQ)

  SDQ 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).

Study Arms (2)

Parenting STAIR Modular (PSTAIR-M)

EXPERIMENTAL

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.

Behavioral: Parenting-STAIR Modular (PSTAIR-M)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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.

Behavioral: Treatment as Usual (TAU)

Interventions

Parenting-STAIR Modular (PSTAIR-M) BEHAVIORAL

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

Parenting STAIR Modular (PSTAIR-M)

Treatment as Usual (TAU) BEHAVIORAL

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

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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)).

Sponsors & Collaborators

• New York University: lead
• Cohen Veterans Network: collaborator
• University of California, Davis: collaborator

Study Sites (3)

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

El Paso, Texas, 79936, United States

RECRUITING

Steven A. Cohen Military Family Clinic at Endeavors, Killeen

Killeen, Texas, 76549, United States

RECRUITING

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

San Antonio, Texas, 78249, United States

RECRUITING

Related Publications (1)

• Sullivan KS, Angelotti G, Zhang F, Kim S, Wortham W, Lindsey MA, Jaccard J, Cloitre M, Timmer S, Linkh DJ, Lancaster SL. Parenting-STAIR Modular: a randomized controlled trial of a trauma-focused parenting intervention for military-connected mothers and their children. Trials. 2026 Jan 13;27(1):118. doi: 10.1186/s13063-025-09369-6.

  PMID: 41526976 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Kathrine S Sullivan, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathrine S Sullivan, PhD

CONTACT

3235526056; ks5313@nyu.edu

Gina M Angelotti, MPH

CONTACT

6462671807; ga2208@nyu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blind to treatment arm. Coders blind to treatment arm will also code 10% of dyadic parenting sessions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 four sessions focused on emotional regulation skill development, four 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).

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 15, 2024
• Study Start: July 21, 2025
• Primary Completion: May 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 30, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The investigative team will publish final results at study completion. Deidentified data will be available to outside investigators through QDR after publication of final results from the trial.
• Access Criteria: Data will be categorized as special access and, due to the sensitivity of the data, will require depositor approval to access. QDR Terms of Use will describe criteria for accessing data, privacy and confidentiality standards consistent with NIH requirements, and conditions for data use that are specific to the project for which data has been requested. Investigators requesting data are expected to demonstrate procedures to ensure data security and will be prohibited from manipulating data for the purposes of identifying research participants. In shared, de-identified data, participants will be assigned new ID numbers that bear no relationship to the original participant's ID numbers. Shared data will be stripped of all identifiers that could potentially lead to deductive disclosure of the participant's identity. Only data necessary to achieve the aims of the specific projects proposed will be shared.

Locations

US (3)