Summary

Eligibility
for females ages 18 years and up (full criteria)
Dates
study started
completion around

Description

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).

Details

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.

Keywords

PTSD, Depression, Parent-Child Relations, Parenting-STAIR

Eligibility

You can join if…

Open to females ages 18 years and up

  1. military connected mother, defined as mothers who are either a female service member or veteran or female spouse of a service member or veteran;
  2. with a child aged 2-10 (if more than one child in this age range, the mother will indicate child with most behavioral difficulties);
  3. lifetime trauma exposure;
  4. screen positive for PTSD defined by scores ≥ 32 on PTSD Checklist-5 (PCL-5) with and without depression (scores ≥ 10 on Patient Health Questionnaire-9 (PHQ-9);
  5. able to speak and understand English or Spanish.
  6. being the legal guardian for the child with physical and legal custody

You CAN'T join if...

  1. high risk for suicide, defined by VA as having intent, means, and a plan;
  2. current psychotic symptoms (SCID);
  3. communication disability (e.g., deafness);
  4. child with diagnosed severe developmental disability
  5. Meeting a diagnosis of severe substance or alcohol use disorder (≥ 6 symptoms on SCID) AND not in early remission (≥3 months without meeting any substance or alcohol use disorder criteria (except craving)

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
New York University
ID
NCT06262178
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated