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Safe Mothers, Safe Children Initiative

Study acronym: SMSC
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 64 words
    • Study description expanded, about 66 words
    v22
  2. Eligibility criteria expanded, about 12 words
    • Secondary endpoints: 8 to 9
    v21
  3. Primary and study completion dates: Sep 30, 2025 to Apr 30, 2027
    • Eligibility criteria revised
    • Study description revised
    v20
  4. Re-verified, no change to tracked fieldsv19
  5. Secondary endpoints: 14 to 8v18
Show 16 earlier versionsHide 16 earlier versions
  1. Enrollment target: 220 to 160v17
  2. Re-verified, no change to tracked fieldsv16
  3. Eligibility criteria expanded, about 19 wordsv15
  4. Secondary endpoints: details revised at 1 of 14 entriesv14
  5. Eligibility criteria shortened, about 9 wordsv13
  6. Re-verified, no change to tracked fieldsv12
  7. Primary endpoints revised (6)
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints revised (14)
    v11
  8. Re-verified, no change to tracked fieldsv10
  9. Start date: May 26, 2021 to May 1, 2021v9
  10. Eligibility criteria expanded, about 1 wordv8
  11. Primary completion date: Jun 30, 2025 to Sep 30, 2025
    • Study completion date: Apr 30, 2026 to Sep 30, 2025
    v7
  12. Eligibility criteria expanded, about 4 wordsv6
  13. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 1, 2021 to May 26, 2021
    • Site details revised
    v5
  14. Start date: Apr 1, 2021 to Jun 1, 2021
    • Primary completion date: May 31, 2025 to Jun 30, 2025
    • Study completion date: Mar 31, 2026 to Apr 30, 2026
    v4
  15. Secondary endpoints: details revised at 1 of 14 entries
    • Eligibility criteria expanded, about 4 words
    v3
  16. Primary endpoints revised (6)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
New York University
52 trials monitored
See 2 trials at risk
Depression
3,055 trials monitored
See 173 trials at risk
PTSD
889 trials monitored
See 54 trials at risk
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.
Trial Details
NCT Number NCT04752618
Lead Sponsor New York University
Conditions
(from sponsor)		 PTSD, Depression, Child Maltreatment
Related terms Depression, Stress Disorders, Post-Traumatic
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov