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Safe Mothers, Safe Children Initiative

Treating Maternal PTSD to Enhance and Reduce Maltreatment Recidivism: Safe Mothers, Safe Children

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests P-STAIR, which combines training in managing feelings and relationships with parent-child therapy. It aims to treat mothers’ PTSD (stress after trauma) and reduce repeated child abuse or neglect. It is for mothers with PTSD and a child ages 1–10, and certain study clinicians.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Mothers: Getting preventive services when agreeing to join the study.
  • Mothers: Have a PTSD test score of 28 or higher, or likely PTSD based on the study’s test.
  • Mothers: Have a child ages 1–10.
  • Mothers: Be the child’s legal guardian with both physical and legal custody.
  • Mothers: Can read, write, and speak English or Spanish.
  • Clinicians: Currently or formerly employed as a Study Clinician or Clinical Director with Safe Mothers, Safe Children.

Who can't join

  • Mothers: Thoughts of suicide in the month before the first assessment, or a suicide attempt in the past year.
  • Mothers: Severe drug or alcohol use disorder, with 6 or more symptoms, unless they have gone at least 3 months without symptoms other than cravings.
  • Mothers: Symptoms of psychosis, such as losing touch with reality, in the past month.
  • Mothers: A disability that affects communication, such as deafness.
  • Mothers: The child taking part has a developmental condition, such as autism, that limits thinking or physical abilities.
  • Mothers: The child taking part has had symptoms or a diagnosis of psychosis in the past 3 months.
  • Mothers: Current or past partner or family violence. If the relationship ended, it must have ended at least 90 days ago with no plan to restart. If it is ongoing, there must have been no violence for at least 1 year.
  • Clinicians: No exclusion rules. They stop completing therapist forms when their role ends or they choose to stop taking part in these forms.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

NY