Safe Mothers, Safe Children Initiative

Part of paid clinical trials in New York, New York.

Sponsor
New York University
Study ID
NCT04752618
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • P-STAIR — BEHAVIORAL
    PCIT+ STAIR
  • Supportive Counseling — BEHAVIORAL
    Non-trauma focused psychotherapy

Study Details

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.

Key Dates

Start date
May 1, 2021
Status verified
Nov 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
McSilver Institute for Poverty Policy and ResearchNew YorkNew York10003
Michael A Lindsey
[email protected]
212-998-5927
Ammu Kowolik
[email protected]
Michael A Lindsey (PRINCIPAL_INVESTIGATOR)
Kathrine Sullivan (SUB_INVESTIGATOR)

Find similar trials in New York, NY

By condition
DepressionPTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
McSilver Institute for Poverty Policy and Research· New York, NY

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