Recruiting

Breaking the Cycle & Maxxine Wright

Sponsor:

University of Ottawa

Code:

NCT05768815

Conditions

Mother-Child Relations

Substance Use

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Breaking the Cycle Program

Maxxine Wright Program

Study Details

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.

Conditions

Mother-Child Relations

Substance Use

Study ID

NCT05768815

Start date

Sep 28, 2023

Status verified date

Mar, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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:

-

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Breaking the Cycle Intervention group

active comparator: Maxxine Wright Intervention group

Interventions

Breaking the Cycle Program

BTC is a prevention and early intervention program in Toronto, Canada, serving substance-using pregnant and/or parenting women with children under six years of age. Established by the Canadian Mothercraft Society in 1995, BTC is funded by the Community Action Program for Children and the Canadian Prenatal Nutrition Program through the Public Health Agency of Canada. BTC provides three program components that act synergistically: a) individualized services for mothers, b) individualized services for children, and c) relational interventions that enhance the mother-child relationship and promote infant mental health. Coordinated supports are offered through formal partnerships across service sectors. In 2004, BTC was recognized by the United Nations as an exemplary program serving pregnant and parenting women with substance use problems, and their young children.

Maxxine Wright Program

Founded in 2005 and located in Surrey, British Columbia, the Maxxine Wright Community Health Centre (MWCHC) supports women who are pregnant and/or have young children and are impacted by substance use and/or violence. Women do not need to have children in their care to receive services. The program is funded and operated by the Fraser Health Authority, with additional in-kind support from the BC Ministry for Children and Family Development and the BC Ministry of Social Development and Poverty Reduction. MW addresses maternal substance use and exposure to violence through women-centered, trauma-informed, culturally grounded, and interdisciplinary approaches. Primary services offered include addiction counselling, primary health care, and group therapy to address interpersonal violence. Within MW, child-focused services are limited to primary health (e.g., well baby checks, childcare).

Primary outcome measure

  • Children's socio-emotional functioning will be measured using the Ages and Stages Questionnaire-Social Emotional (ASQ-SE-2) [ Time Frame: Change from pre-intervention to 12 months after engagement and 24 months after engagement ]
  • Children's developmental functioning will be measured using the Ages and Stages Questionnaire-Third Edition (ASQ-3) [ Time Frame: Change from pre-intervention to 12 months after engagement and 24 months after engagement ]

Central Contacts and Locations

Central contacts

Nicole Racine, PhD, C.Psych

403-992-7869nracine2@uottawa.ca

Locations

Maxxine Wright Community Health Centre

Recruiting

Surrey, British Columbia, Canada, V3V 1H9

Contacts

Mothercraft, Breaking the Cycle

Recruiting

Toronto, Ontario, Canada, M5A 1L3

Contacts

More Information

Sponsor

University of Ottawa

Last update posted

May 23, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Ottawa on 2024-05-23.