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Recruiting NCT06262178

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

No phase Interventional PTSD Depression Parent-Child Relations

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Parenting-STAIR Modular (PSTAIR-M), Treatment as Usual (TAU).
Who it may be relevant to
Registry conditions: PTSD, Depression, Parent-Child Relations. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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=60 mothers; 60 children) or treatment-as-usual (TAU; N=60 mothers; 60 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.

Interventions

  • Behavioral Parenting-STAIR Modular (PSTAIR-M)
    12-16 PSTAIR-M treatment sessions (approximately 12-16 weeks).
  • 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.

Primary outcome measures

  • 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).]
Secondary outcome measures (6)
  • Difficulties in Emotion Regulation Scale (DERS) [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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).]
  • Military Stress of Life Survey [Time frame: Military Stress of Life Survey will be administered at two assessment timepoints: pre-treatment (baseline) and post-treatment (approximately 17 weeks after baseline).]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Steven A. Cohen Military Family Clinic at Endeavors, El Paso — El Paso
  • Steven A. Cohen Military Family Clinic at Endeavors, Killeen — Killeen
  • Steven A. Cohen Military Family Clinic at Endeavors, San Antonio — San Antonio

Publications

  • 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

Identifiers

NCT: NCT06262178 · 23-1393

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗