Program to help mothers with PTSD and improve parenting skills

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a combined intervention approach using Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Interaction Therapy (PCIT) to treat maternal PTSD and reduce child maltreatment. It is a two-arm randomized controlled trial where participants are assigned to either the P-STAIR program or supportive counseling. Mothers participating in the study will undergo assessments at various stages, including pre-treatment, during treatment, and at a 6-month follow-up to measure symptom progress. The target population includes mothers with children aged 1-8 years who are receiving family preservation services.

Why it matters

Who can join: the full rules

Inclusion Criteria (mothers):

* Receiving preventive services at the time of the consent session to participate in the study
* 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 Criteria (mothers):

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If there is a history of IPV/family violence and the relationship is no longer active, the relationship must have ended for at least ninety days with no intention of restarting; If there is a history of IPV/family violence, but the relationship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

Inclusion criteria (clinicians):

\- Must be a currently or formerly hired Study Clinician or Clinical Director with Safe Mothers, Safe Children.

Exclusion criteria (clinicians):

\- There are no exclusion criteria for this population. Participants in this population will cease completion of therapist-copy measures upon the conclusion of their role with Safe Mothers, Safe Children, or upon withdrawal from participation in these measures.

Where it's running

• McSilver Institute for Poverty Policy and Research
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Michael A Lindsey — New York University
• Study coordinator: Erin A Montion, MA
• Email: em5935@nyu.edu
• Phone: ‪(929) 489-1501‬

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.