Safe Mothers, Safe Children Initiative

NCT ID: NCT04752618

Last Updated: 2026-02-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2027-04-30

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.

Detailed Description

This study is a two-arm randomized controlled trial (RCT): P-STAIR (23 sessions) vs. supportive counseling (SC) (23 sessions). Eligible cases are randomized to P-STAIR and SC in a 1:1 ratio. Participants will be mothers receiving family preservation services (FPS), with a child in the age range of 1-10 years old, and PTSD (with/without depression). Symptom progress will be measured at pre-treatment, two in-treatment assessments (9 weeks and 16 weeks), post-treatment, and at a 6-month follow-up.

Conditions

PTSD; Depression; Child Maltreatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

P-STAIR

Participants will receive 23 weekly individual treatment sessions. Each session will last one hour. P-STAIR is a combination of STAIR and PCIT. STAIR focuses on reduction of PTSD symptoms through enhancement of emotion regulation skills. PCIT focuses on the reduction of negative parenting skills and the increase of positive parenting skills.

Group Type: EXPERIMENTAL

P-STAIR

Intervention Type: BEHAVIORAL

PCIT+ STAIR

Supportive Counseling

Participants will receive 23 weekly individual treatment sessions. Each session will last one hour. Supportive counseling has been modified to permit non-trauma discussion of parenting problems. Each session is client-directed and clinicians take an unconditionally supportive role.

Group Type: ACTIVE_COMPARATOR

Supportive Counseling

Intervention Type: BEHAVIORAL

Non-trauma focused psychotherapy

Interventions

P-STAIR

PCIT+ STAIR

Intervention Type: BEHAVIORAL

Supportive Counseling

Non-trauma focused psychotherapy

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

New York University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael A Lindsey

Role: PRINCIPAL_INVESTIGATOR

New York University

Locations

McSilver Institute for Poverty Policy and Research

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hanaan Osman

Role: CONTACT

ho2233@nyu.edu

212-998-4296 ext. 84296

Facility Contacts

Michael A Lindsey

Role: primary

ml4361@nyu.edu

212-998-5927

Ammu Kowolik

Role: backup

ammu@nyu.edu

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB-FY2021-5220

Identifier Type: -

Identifier Source: org_study_id