Clinical trial Recruiting at 2 sites Interventional Women only

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.

More Substance Use trials

Quick facts

Study typeInterventional
SexWomen only
Enrollment100 (estimated)
SponsorUniversity of Ottawa
Academic / other
Locations2 sites (Surrey, British Columbia and 1 other locations)
StatusRecruiting
StartedSeptember 28, 2023
Main results expectedSeptember 2026
Study endsDecember 2026
Registry record updatedMay 23, 2024
Trial IDNCT05768815 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.