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Clinical Trial Summary

The purpose of this study, which includes a clinical trial, is to adapt and assess the efficacy of Parenting-STAIR (PSTAIR), an intervention which combines existing evidence-based treatments Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Care (PC-Care) to reduce symptoms of Post-traumatic Stress Disorder (PTSD) and improve parenting among military-connected mothers. Participants in the clinical trial will receive PSTAIR or trauma-focused treatment as usual (either prolonged exposure or cognitive processing therapy).


Clinical Trial Description

This study will proceed in three phases. In phase 1, the investigators conduct qualitative interviews and focus groups with key informants including military-connected mothers (MCM) to guide adaptation of PSTAIR in Phase 2. The investigators anticipate the outcome of Phase 2 will be a 10-15 session intervention (PSTAIR-M), involving a compact version of PSTAIR in Module 1 and tailored options for Module 2, focusing on mental health (Module 2a) and parental functioning (Module 2b), implemented based on response to Module 1. Phase 3 is a two-arm randomized controlled trial (RCT): PSTAIR (10-15 sessions) vs. treatment as usual (TAU). Eligible cases are randomized to PSTAIR and TAU in a 1:1 ratio. Participants will be trauma-exposed MCM who screen positive for PSTD with/without comorbid depression and one identified child (ages 2-10). Assessments will occur at 3 timepoints. Pre- and post-treatment will include self-report and clinician-administered instruments and dyadic parenting observations. Midpoint assessment (after session 10 to assess change after PSTAIR Module 1) will include only self-report and dyadic observation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06262178
Study type Interventional
Source New York University
Contact Kathrine S Sullivan, PhD
Phone 3235526056
Email ks5313@nyu.edu
Status Not yet recruiting
Phase N/A
Start date April 2024
Completion date March 2026

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