NCT05768815 Optimizing Mental Health for Infants Exposed to Early Adversity: A Comparison of Breaking the Cycle and Maxxine Wright
| NCT ID | NCT05768815 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Ottawa |
| Condition | Mother-Child Relations |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-09-28 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-09-28 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * receiving services at either BTC or MW * having a child under the age of 6 years * being able to answer a questionnaire in English Exclusion Criteria: \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05768815 clinical trial?
This trial is open to female participants only, studying Mother-Child Relations. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05768815 currently recruiting?
Yes, NCT05768815 is actively recruiting participants. Contact the research team at nracine2@uottawa.ca for enrollment information.
Where is the NCT05768815 trial being conducted?
This trial is being conducted at Surrey, Canada, Toronto, Canada.
Who is sponsoring the NCT05768815 clinical trial?
NCT05768815 is sponsored by University of Ottawa. The trial plans to enroll 100 participants.