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Search / Trial NCT04752618

Safe Mothers, Safe Children Initiative

Launched by NEW YORK UNIVERSITY · Feb 9, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

The Safe Mothers, Safe Children Initiative is a clinical trial designed to help mothers who are dealing with mental health challenges, specifically post-traumatic stress disorder (PTSD) and depression, while also addressing issues of child maltreatment. The study will evaluate the effectiveness of two treatments: Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Interaction Therapy (PCIT), together referred to as P-STAIR. This trial aims to see if these combined approaches can improve the well-being of mothers and their young children, aged 1 to 8 years.

To participate, mothers must currently be receiving preventive services and score 28 or higher on a PTSD assessment. They also need to be the legal guardian of their child and able to communicate in English or Spanish. However, those with certain severe mental health issues, like suicidal thoughts or substance use disorders, or those who have experienced recent intimate partner violence, are not eligible to join. Participants can expect support and treatment designed to help them improve their mental health and strengthen their relationship with their children. The trial is currently recruiting participants, so interested mothers are encouraged to reach out for more information.

Gender

FEMALE

Eligibility criteria

  • 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

About New York University

New York University (NYU) is a prestigious research institution renowned for its commitment to advancing medical knowledge and improving patient care through innovative clinical trials. With a robust infrastructure and a diverse team of leading experts, NYU conducts cutting-edge research across various therapeutic areas, focusing on translating scientific discoveries into effective treatments. The university fosters collaboration among multidisciplinary teams and engages with a broad patient population, ensuring that its trials adhere to the highest ethical standards and regulatory requirements. NYU's dedication to excellence in research and education positions it as a key contributor to the advancement of healthcare and clinical practice.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Michael A Lindsey

Principal Investigator

New York University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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