Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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 five sessions focused on emotional regulation skill development, three 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).
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
Assessors will be blind to treatment arm. Coders blind to treatment arm will also code 10% of dyadic parenting sessions.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Parenting STAIR Modular (PSTAIR-M)
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)
    12-16 PSTAIR-M treatment sessions (approximately 12-16 weeks).
Active Comparator
Treatment as Usual (TAU)
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)
    Weekly treatment sessions of an established EBT. The total number of sessions/weeks will be determined by the EBT and clinic protocols.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
New York University

Study Contact

Kathrine S Sullivan, PhD
3235526056
ks5313@nyu.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.