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

New York University (NYU)

Status: Begins enrollment this month

Conditions: PTSD; Parent-Child Relations; Depression

Treatments: Behavioral: Parenting-STAIR Modular (PSTAIR-M); Behavioral: Treatment as Usual (TAU)

Study type: Interventional

Funder types: Other

Identifiers

NCT06262178

23-1393

Details and patient eligibility

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). 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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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))

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Parenting STAIR Modular (PSTAIR-M)

Experimental group

Description:

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.

Treatment:

Behavioral: Parenting-STAIR Modular (PSTAIR-M)

Treatment as Usual (TAU)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Treatment as Usual (TAU)