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Safe Mothers, Safe Children Initiative

Safe Mothers, Safe Children Initiative

Recruiting
18 years and older
Female
Phase N/A

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Overview

The purpose of this study is to assess the efficacy of the combined interventions, Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Interaction Therapy (PCIT) or P-STAIR, for treating maternal PTSD and reducing maltreatment recidivism.

Description

This study is a two-arm randomized controlled trial (RCT): P-STAIR (23 sessions) vs. supportive counseling (SC) (23 sessions). Eligible cases are randomized to P-STAIR and SC in a 1:1 ratio. Participants will be mothers receiving family preservation services (FPS), with a child in the age range of 1-8 years old, and PTSD (with/without depression). Symptom progress will be measured at pre-treatment, two in-treatment assessments (9 weeks and 16 weeks), post-treatment, and at a 6-month follow-up.

Eligibility

Inclusion Criteria:

  • Receiving preventive services
  • Meeting a severity score of 28 or higher OR probable DSM-5 diagnostic criteria for PTSD (PDS-5)
  • Having 1-8-year-old child
  • Being the legal guardian for the child with physical and legal custody
  • Being able to read, write, and speak English or Spanish

Exclusion Criteria:

  • Having suicidal ideation present in the past month prior to pre-assessment or reports of a suicide attempt in the past year (SCID-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)
  • Having current or active symptoms of psychosis in the past month
  • Having a disability affecting communication, such as deafness
  • Having an index child with a developmental condition that impedes cognitive and/or physical functioning, e.g. autism
  • Having an index child with current symptoms or diagnosis of psychosis as defined by the DSM-5 in the past 3 months
  • Experiencing current or history of intimate partner violence (IPV) or family violence:
        If there is a history of IPV/family violence and the relationship is no longer active, the
        relationship must have ended for at least ninety days with no intention of restarting; If
        there is a history of IPV/family violence, but the relationship is ongoing, there must not
        have been an IPV/family violence event for at least one year

Study details
    PTSD
    Depression
    Child Maltreatment

NCT04752618

New York University

26 June 2024

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