Program to help mothers with PTSD and improve parenting skills
Treating Maternal PTSD to Enhance and Reduce Maltreatment Recidivism: Safe Mothers, Safe Children
NA · New York University · NCT04752618
This study is testing a new program to help mothers with PTSD improve their parenting skills and reduce the risk of harming their children.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | New York University (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04752618 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are mothers with PTSD who have children aged 1-8 years and are receiving family preservation services.
Not a fit: Patients with severe substance use disorders, active psychosis, or those whose children have developmental conditions that impede functioning may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve mental health outcomes for mothers and enhance parenting skills, ultimately reducing child maltreatment.
How similar studies have performed: Other studies have shown promise in using combined therapeutic approaches for treating PTSD and improving parenting skills, suggesting potential success for this intervention.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: PTSD, Depression, Child Maltreatment