Comparing two programs to improve mental health in infants of substance-involved mothers
Optimizing Mental Health for Infants Exposed to Early Adversity: A Comparative Effectiveness Trial of the Breaking the Cycle and Maxxine Wright Intervention Programs
NA · University of Ottawa · NCT05768815
This study is testing which of two programs better helps mothers with substance use issues and their infants improve their mental health and relationships over two years.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | Female |
| Sponsor | University of Ottawa (other) |
| Locations | 2 sites (Surrey, British Columbia and 1 other locations) |
| Trial ID | NCT05768815 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two programs, Breaking the Cycle (BTC) and Maxxine Wright (MW), in supporting substance-involved mothers and their children. The BTC program includes an infant mental health component, while the MW program focuses primarily on the mothers. The study will assess outcomes such as infant mental health, maternal stress, and the quality of mother-child relationships over a two-year period. By comparing these two approaches, the trial seeks to identify which program better supports both maternal and child well-being.
Who should consider this trial
Good fit: Ideal candidates for this study are substance-involved mothers with children under the age of 6 who are receiving services at either the BTC or MW programs.
Not a fit: Patients who do not have children under the age of 6 or are not involved in substance use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mental health outcomes for infants and better parenting practices among mothers with substance use issues.
How similar studies have performed: Other studies have shown success in similar interventions aimed at improving maternal and child health outcomes, suggesting that this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion 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: \-
Where this trial is running
Surrey, British Columbia and 1 other locations
- Maxxine Wright Community Health Centre — Surrey, British Columbia, Canada (RECRUITING)
- Mothercraft, Breaking the Cycle — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: Nicole Racine, PhD, C.Psych
- Email: nracine2@uottawa.ca
- Phone: 403-992-7869
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mother-Child Relations, Substance Use