NCT06262178 · New York University
Parenting STAIR: Adapting a Trauma-Focused Parenting Intervention for Military-Connected Mothers and Their Children
What this study is about
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).
View original scientific description
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.
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).
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.
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).
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.
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).
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)).
Where
- El Paso, Texas
- Killeen, Texas
- San Antonio, Texas
Collaborators
Cohen Veterans Network, University of California, Davis
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations