Status:
RECRUITING
Safe Mothers, Safe Children Initiative
Lead Sponsor:
New York University
Conditions:
PTSD
Depression
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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-ST...
Detailed 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. Participa...
Eligibility Criteria
Inclusion
- Receiving preventive services
- Meeting a severity score of 28 or higher OR probable DSM-5 diagnostic criteria for PTSD (PDS-5)
- Having 1-10-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
- 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- If there is a history of IPV/family violence and the relationship is no longer active, the relationship must have ended for at least ninety days with no intention of restarting; If there is a history of IPV/family violence, but the relationship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
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04752618
Start Date
May 1 2021
End Date
April 30 2027
Last Update
November 21 2025
Active Locations (1)
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1
McSilver Institute for Poverty Policy and Research
New York, New York, United States, 10003