Safe Mothers, Safe Children Initiative

Last updated: November 22, 2024
Sponsor: New York University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Post-traumatic Stress Disorders

Treatment

P-STAIR

Supportive Counseling

Clinical Study ID

NCT04752618
IRB-FY2021-5220
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Receiving preventive services

  • Meeting a severity score of 28 or higher OR probable DSM-5 diagnostic criteria forPTSD (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

Exclusion Criteria:

  • Having suicidal ideation present in the past month prior to pre-assessment orreports of a suicide attempt in the past year (SCID-5)

  • Meeting a diagnosis of severe substance or alcohol use disorder (≥ 6 symptoms onSCID) AND not in early remission (≥3 months without meeting any substance or alcoholuse 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/orphysical functioning, e.g. autism

  • Having an index child with current symptoms or diagnosis of psychosis as defined bythe DSM-5 in the past 3 months

  • Experiencing current or history of intimate partner violence (IPV) or familyviolence:

If there is a history of IPV/family violence and the relationship is no longer active, the relationship must have ended for at least ninety days with no intention of restarting; If there is a history of IPV/family violence, but the relationship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 Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: P-STAIR
Phase:
Study Start date:
May 01, 2021
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • McSilver Institute for Poverty Policy and Research

    New York, New York 10003
    United States

    Active - Recruiting

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