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

Not Applicable

Not yet recruiting

• Conditions: Parent-Child Relations; PTSD; Depression
• Interventions: Behavioral: Parenting-STAIR; Behavioral: Treatment as Usual

• Registration Number: NCT06262178
• Lead Sponsor: New York University

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 1-1.5-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 and treatment sessions audio and video recorded.

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 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.

Study Timeline

• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-02-08
• Study First Posted: 2024-02-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-30
• Study Start: 2025-06
• Primary Completion: 2026-05
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 120

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 by scores ≥ 32 on the PCL-5 and/or depression scores ≥ 10 on the PHQ-9;
6. Able to speak and understand English or Spanish

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))

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parenting-STAIR	Parenting-STAIR	PSTAIR is a 23 session 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. We propose to shorten PSTAIR into a 10-15 session modular intervention and individualize treatment using an adaptive decision rule and shared decision making (SDM).
Treatment As Usual	Treatment as Usual	Participants in the comparison condition will be assigned to treatment as usual. All participating clinics offer Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT), both trauma-focused EBTs. Though some differences have been noted, evidence suggests outcomes for PE and CPT are broadly equivalent. Participants in the comparison condition will receive PE or CPT, as determined by Cohen Veterans Network (CVN) clinics' standard treatment assignment procedures, and will participate in assessments on the same schedule as the treatment condition.

Primary Outcome Measures

Name	Time	Method
Post-traumatic stress disorder (PTSD) Checklist 5	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)	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)	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.

Secondary Outcome Measures

Name	Time	Method
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).	DERS, which measures emotion regulation, will be evaluated as a potential mediator. DERS is a 36-item self-report measure with adequate reliability and construct and predictive validity. Participants indicate how true or untrue various statements about emotions are for them (e.g., "I have no idea how I am feeling"; "I know exactly how I am feeling") on a 5-point Likert scale (1=almost never; 2=sometimes; 3=about half the time; 4=most of the time; 5=almost always). Summed responses yield a continuous score ranging from 36 to 180; higher scores indicate greater emotion regulation difficulty.
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).	Brief Cope, which measures coping, will be evaluated as a potential mediator. Brief Cope is a 28-item self-report measure with adequate reliability and convergent and discriminant validity. Participants indicate how much or how often they have used various coping strategies (e.g., "I used alcohol or other drugs to make myself feel better"; "I took action to try to make the situation better") on a 4-point Likert scale (0=I didn't do this at all; 1=I did this a little bit; 2=I did this a medium amount; 3=I did this a lot). Summed responses within each of 14 subscales (e.g., substance use; active coping) yields a continuous score ranging from 0 to 6; higher scores indicate greater use of a particular coping strategy.
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).	Parent interaction will be videotaped and coded by independent assessors. 10% of recordings will also be coded at UC Davis Parent-Child Interaction Therapy (PCIT) Training Center by expert coders unaware of treatment condition. Positive scores include the number of observed praises, reflections, and behavioral descriptions used during the play session, and negative scores include the number of observed questions, commands, and negative talk. DPICS is administered for 15-minutes in total with three 5-minute sessions focusing on child-directed play (CDI), parent-directed play (PDI), and clean-up.
Treatment Acceptability and Expectations (TAE)	The TAE will be administered following the first treatment session and during the post-treatment assessment (approximately 17 weeks after baseline).	TAE is a 5-item measure developed by study co-investigator Dr. Marylene Cloitre, will be used to assess acceptability and feasibility of the intervention. Participants are asked to appraise the intervention (e.g., "How logical does this type of treatment seem to you?"; "How successful do you think this treatment will be in reducing your trauma symptoms?") on an 8-point Likert scale (0=not at all; 2=very little; 4=somewhat; 6=moderate; 8=extremely). Summed responses yield a continuous score ranging from 0 to 40; higher scores indicate greater acceptability.
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).	The SDQ will be used to assess child behaviors. The SDQ is a 25-item parent-report measure with good reliability, cross-informant correlation, and retest stability. Participant mothers indicate how true or untrue various statements about child behavior are relative to their participating child (e.g., "Shares readily with other children, for example toys, treats, pencils", "Often fights with other children or bullies them") on a 3-point Likert scale (0=not true; 1=somewhat true; 2=certainly true). Summed responses yield a continuous score ranging from 0 to 40; higher scores indicate greater behavioral difficulty.
Military Stress of Life Survey	Military Stress of Life Survey will be administered at two assessment timepoints: pre-treatment (baseline) and post-treatment (approximately 17 weeks after baseline).	The Military Stress of Life Survey, a 14-item self-report measure adapted from the Department of Defense (DoD) Navy and Marine Stress of Life Survey, has been adapted for this study to assess lifetime and recent burden of military-related stressors. Participants indicate (0=no; 1=yes) whether they and their families have ever experienced various stressful situations associated with military life (e.g., "A combat-related injury"; "Difficulty balancing the demands of family life and military duties"), and if so, whether the experience occurred within the last 12 months. For every "yes" response, participants rate how stressful the particular experience was on a 4-point Likert scale (0=not stressful at all; 1=slightly stressful; 2=moderately stressful; 3=very stressful). Summed responses yield a continuous score ranging from 0 to 42; higher scores indicate a greater burden of military-related stressors.