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Optimizing Mental Health for Infants Exposed to Early Adversity: A Comparison of Breaking the Cycle and Maxxine Wright

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated May 23, 2024 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Secondary endpoints: 9 to 11
    • Site details revised at 2 of 2 sites
    v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2023 to Sep 28, 2023
    • Site details revised at 2 of 2 sites
    v4
  3. Start date: Jul 2023 to Sep 2023
    • Primary completion date: Jul 2026 to Sep 2026
    • Study completion date: Oct 2026 to Dec 2026
    v3
  4. Start date: May 2023 to Jul 2023
    • Primary completion date: May 2026 to Jul 2026
    • Study completion date: Aug 2026 to Oct 2026
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to compare the effectiveness of the Breaking the Cycle (BTC) and Maxxine Wright (MW) programs in substance-involved mothers and their children. One key difference between the two programs is that the BTC program contains an infant mental health component while the MW program primarily focuses on the mothers. The main questions the trial aims to answer are: * Do children at BTC demonstrate enhanced infant mental health compared to children at MW up to 2 years post-intervention? * Do mother-child dyads at BTC experience more decreases in child adverse childhood experiences (ACE), maternal stress, and mental health symptoms and have better home environment scores, parenting attitudes, and mother-child relationship scores compared to mother-child dyads at MW? * Are enhanced infant mental health outcomes associated with children's lower psychosocial risk scores and mothers with lower ACE scores, lower depression and anxiety scores, and lower maternal stress? * Are the associations between treatment dose and infant mental health scores mediated by parenting attitudes and the mother-child relationship? Does child exposure to psychosocial risk moderate the association between treatment dose and child outcomes? * How do the mechanisms of change lead to the effectiveness of BTC? What are the potential lifetime health and non-health outcomes of at-risk children at BTC? What is the long-term social return on investment (SROI) of BTC? Participants will complete several questionnaires at three timepoints while receiving services at either BTC or MW: during the intake phase, 12 months after their engagement in services and 24 months after their engagement in services. Given that the two programs serve a similar demographic of women, researchers will compare the BTC group and the MW group to establish the comparative effectiveness and mechanisms of change of the infant mental health component of BTC.
Trial Details
NCT Number NCT05768815
Lead Sponsor University of Ottawa
Conditions
(from sponsor)		 Mother-Child Relations, Substance Use
Related terms Substance-Related Disorders
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov