| NCT ID | NCT04752618 |
| Status | Recruiting |
| Phase | — |
| Sponsor | New York University |
| Condition | PTSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2021-05-01 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2021-05-01 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-STAIR, for treating maternal PTSD and reducing maltreatment recidivism.
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partner violence (IPV) or family violence: If there is a history of IPV/family violence and the relationship is no longer active, the relationship must have ended for at least ninety days with no intention of restarting; If there is a history of IPV/family violence, but the relationship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.
Contact & Investigator
Michael A Lindsey
PRINCIPAL INVESTIGATOR
New York University
Frequently Asked Questions
Who can join the NCT04752618 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PTSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04752618 currently recruiting?
Yes, NCT04752618 is actively recruiting participants. Contact the research team at em5935@nyu.edu for enrollment information.
Where is the NCT04752618 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT04752618 clinical trial?
NCT04752618 is sponsored by New York University. The principal investigator is Michael A Lindsey at New York University. The trial plans to enroll 160 participants.
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