Comparing two programs to improve mental health in infants of substance-involved mothers
Official title: Optimizing Mental Health for Infants Exposed to Early Adversity: A Comparative Effectiveness Trial of the Breaking the Cycle and Maxxine Wright Intervention Programs
Run by University of Ottawa · NCT05768815 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | University of Ottawa Academic / other |
| Locations | 2 sites (Surrey, British Columbia and 1 other locations) |
| Status | Recruiting |
| Started | September 28, 2023 |
| Main results expected | September 2026 |
| Study ends | December 2026 |
| Registry record updated | May 23, 2024 |
| Trial ID | NCT05768815 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown success in similar interventions aimed at improving maternal and child health outcomes, suggesting that this approach may be promising.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
iPAWS: Helping teens manage pain and risky behaviors after wisdom tooth removal
This program tests a short online intervention to help teens and their parents handle post-surgical pain and reduce risky behaviors after wisdom tooth extraction.
-
Returning to the Land intervention for families in a tribal community
This program tests a biodiverse outdoor intervention with a tribal community to help reduce caregiver substance use and support emotional/behavioral development in children ages 1–5, by engaging families where teens 14–19 participate.
-
Connecting incarcerated adults with virtual peer recovery coaches to support addiction care
This trial tests whether a virtual peer recovery coach program helps people in jail link to and stick with addiction treatment compared to standard care.
-
Mindfulness training to reduce childbirth fear and strengthen bonding and breastfeeding in pregnant teens
This program will try mindfulness-based stress reduction (MBSR) with pregnant teens and their partners to see if it lowers fear of childbirth, improves parent–infant bonding, and increases breastfeeding success.
-
Screening and brief counseling for substance use in adult survivors of childhood cancer
This study tests whether a short, evidence-based substance-use screening plus a brief counseling session can be added into routine survivorship care for adult survivors of childhood cancer at St. Jude.
-
Host-led harm reduction for men who have sex with men who engage in chemsex in Bangkok
This project will try a host-led harm reduction approach to reduce substance-related, sexual, mental health, and legal harms among men who have sex with men who engage in chemsex in Bangkok.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.