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

Recruiting now · Not applicable

Conditions studied: Mother-Child Relations, Substance Use

In brief

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.

Key facts

Study ID
NCT05768815
Run by
University of Ottawa
People needed
100
Starts
2023-09-28
Expected to finish
2026-12-01
Last updated by the study team
2024-05-23

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Where it is running

Full record on ClinicalTrials.gov

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