Recruiting

Observational Study

Sponsor:

New York University

Code:

NCT04752618

Conditions

PTSD

Depression

Child Maltreatment

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

P-STAIR

Supportive Counseling

Study Details

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.

Conditions

PTSD

Depression

Child Maltreatment

Study ID

NCT04752618

Start date

May 1, 2021

Status verified date

Nov, 2025

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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If there is a history of IPV/family violence and the relationship is no longer active, the relationship must have ended for at least ninety days with no intention of restarting; If there is a history of IPV/family violence, but the relationship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

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

P-STAIR

PCIT+ STAIR

Supportive Counseling

Non-trauma focused psychotherapy

Primary outcome measure

  • Post-traumatic Stress Diagnostic Scale for the DSM-5 (PDS-5) [ Time Frame: Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion ]
  • Center for Epidemiological Studies-Depression (CES-D) [ Time Frame: Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion ]
  • Dyadic Parent-Child Interaction Coding System-IV (DPICS) [ Time Frame: Change from baseline (pre-treatment) to mid-treatment at session 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion ]
  • New foster care removals [ Time Frame: Every six-months for 10 years ]
  • New child abuse/neglect welfare reports [ Time Frame: Every six-months for 10 years ]
  • Family Preservation Services Usual Care (FPSUC) reports [ Time Frame: Throughout study completion, an average 43 weeks ]

Central Contacts and Locations

Central contacts

Erin A Montion, MA

‪(929) 489-1501‬em5935@nyu.edu

Locations

McSilver Institute for Poverty Policy and Research

Recruiting

New York, New York, United States, 10003

Contacts

Michael A Lindsey

212-998-5927ml4361@nyu.edu

Ammu Kowolik

ammu@nyu.edu

Principal Investigator:

Michael A Lindsey

More Information

Sponsor

New York University

Last update posted

May 7, 2026

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York University on 2026-05-07.