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Study identifier: NCT05768815 Synced from ClinicalTrials.gov · July 29, 2026
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Optimizing Mental Health for Infants Exposed to Early Adversity: A Comparison of Breaking the Cycle and Maxxine Wright

Condition: Mother-Child Relations · Substance Use  ·  Sponsor: University of Ottawa

PhaseNA
Planned participants100
Who can joinFemale, N/A to no upper limit
Healthy volunteersNo

About this study

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…

This description comes directly from the study's public registry record.

Talk to the study team

Nicole Racine, PhD, C.Psych  ·  403-992-7869  ·  nracine2@uottawa.ca

Always discuss trial participation with your own doctor first.

Locations (2)

Maxxine Wright Community Health CentreSurrey, British Columbia, CanadaRecruiting
Mothercraft, Breaking the CycleToronto, Ontario, CanadaRecruiting

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Source record: clinicaltrials.gov/study/NCT05768815