Safe Mothers, Safe Children Initiative

NCT04752618 | Recruiting DMC

• 1 other identifier: IRB-FY2021-5220
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Post-traumatic Stress Diagnostic Scale for the DSM-5 (PDS-5)

  Post-traumatic Stress Diagnostic Scale for the DSM-5 (PDS-5) is a 24-item self-report measure of PTSD symptoms over the last month. Items are rated on a 5-point scale of frequency and severity ranging from 0 ("not at all") to 4 ("6 or more times a week/severe"). Higher scores indicate more severe PTSD symptoms. PDS-5 will be used to monitor change in PTSD symptoms over treatment implementation. PDS-5 is also used during the baseline to evaluate for inclusion/exclusion criteria.

  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)

  Center for Epidemiological Studies-Depression (CES-D) is a 20-item self-report measure of symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Items are rated on a 3-point scale ranging from 0 ("rarely or none of the time") to 3 ("most or almost all of the time"). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. CES-D will be used to assess change in depression symptoms over treatment implementation.

  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)

  Dyadic Parent-Child Interaction Coding System-IV (DPICS) examines the quality of parent-child social interaction in three 5-minute situations: child-directed play, parent-directed play, and clean-up. Positive skills include praise, reflect, and describe, and negative skills include questions, commands, and criticisms. Observations are coded by trained DPICS scorers to produce total scores. DPICS scores allow us to track the changes in positive and negative parenting scores over treatment implementation.

  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

  Data is collected through the New York State Child Welfare Registry (NYSCWR) semi-annually on the number of out-of-home placements for 10 years for completers and non-completers who have consented into the study. Number of new foster care removals are located by unique NYSCWR identifiers collected at time of consent. Out-of-home placement data, in addition to new substantiated welfare reports, will be used to assess recidivism.

  Every six-months for 10 years

• New child abuse/neglect welfare reports

  Data is collected through the New York State Child Welfare Registry (NYSCWR) semi-annually on the number of substantiated abuse/neglect reports for 10 years for completers and non-completers who have consented into the study. Number of new substantiated reports are located by unique NYSCWR identifiers collected at time of consent. New substantiated welfare reports, as well as out-of-home placement data, will be used to assess recidivism.

  Every six-months for 10 years

• Family Preservation Services Usual Care (FPSUC) reports

  Family Preservation Services Usual Care (FPSUC) is extracted from electronic records that agencies use to document services. FPSUC details the number of services accessed in preventative agencies for clients. Data will be used to statistically control for FPSUC.

  Throughout study completion, an average 43 weeks

Secondary Outcomes (9)

• Structured Clinical Interview for DSM-5 (SCID-5)

  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

• Difficulties in Emotion Regulation Scale (DERS)

  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

• Adult Adolescent Parenting Inventory-2.1 (AAPI-2.1)

  Change from baseline (pre-treatment) to end of treatment (average 43 weeks) to six-month follow-up

• Treatment Services Review (TSR)

  Baseline (pre-treatment)

• Treatment Services Review (TSR)

  End of treatment (an average 43 weeks)

Study Arms (2)

P-STAIR

EXPERIMENTAL

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.

Behavioral: P-STAIR

Supportive Counseling

ACTIVE COMPARATOR

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.

Behavioral: Supportive Counseling

Interventions

Supportive Counseling BEHAVIORAL

Non-trauma focused psychotherapy

Supportive Counseling

P-STAIR BEHAVIORAL

PCIT+ STAIR

P-STAIR

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: To receive the study intervention, participants must be mothers. Child gender is a control variable. Participants in the clinician group may identify with any gender in order to participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• \- Must be a currently or formerly hired Study Clinician or Clinical Director with Safe Mothers, Safe Children.

Sponsors & Collaborators

• New York University: lead

Study Sites (1)

McSilver Institute for Poverty Policy and Research

New York, New York, 10003, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Michael A Lindsey

  New York University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin A Montion, MA

CONTACT

‪(929) 489-1501‬; em5935@nyu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors and preventive case planners are blind to treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: P-STAIR vs Supportive Counseling

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 12, 2021
• Study Start: May 1, 2021
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 7, 2026

Record last verified: 2025-11

Locations

US (1)