Optimizing Mental Health for Infants Exposed to Early Adversity: A Comparison of Breaking the Cycle and Maxxine Wright

Optimizing Mental Health for Infants Exposed to Early Adversity: A Comparative Effectiveness Trial of the Breaking the Cycle and Maxxine Wright Intervention Programs

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.

Study Overview

• Status: Recruiting
• Conditions: Substance Use; Mother-Child Relations
• Intervention / Treatment: Behavioral: Breaking the Cycle Program; Behavioral: Maxxine Wright Program

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicole Racine, PhD, C.Psych; Phone Number: 403-992-7869; Email: nracine2@uottawa.ca

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 1H9
      • Recruiting
      • Maxxine Wright Community Health Centre
      • Contact: Denise Penaloza; Email: denise.penaloza@fraserhealth.ca
  • Ontario
    • Toronto, Ontario, Canada, M5A 1L3
      • Recruiting
      • Mothercraft, Breaking the Cycle
      • Contact: Mary Motz; Phone Number: 416-364-7373; Email: mary.motz@mothercraft.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breaking the Cycle Intervention group	Behavioral: 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.
Active Comparator: Maxxine Wright Intervention group	Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's socio-emotional functioning will be measured using the Ages and Stages Questionnaire-Social Emotional (ASQ-SE-2)	The ASQ-SE-2 is a 26-item, parent-completed questionnaire that is highly reliable and focuses solely on social-emotional development in young children aged 1-72 months.	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)	The ASQ-3 consists of a series of parent-completed questionnaires to assess child development across five domains for children 1 to 66 months: communication, gross motor, fine motor, problem-solving, and personal-social skills.	Change from pre-intervention to 12 months after engagement and 24 months after engagement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's exposure to risk and protective factors will be measured using a cumulative risk measure (Bondi et al., 2020)	This cumulative risk measure is designed to identify risk and protective factors for children of substance-involved mothers. It will be used to assess children's exposure to risk (e.g., ACEs, poverty, maternal mental illness) and protective factors (e.g., family social support, childcare, community supports).	Change from pre-intervention to 12 months after engagement and 24 months after engagement
Sensitivity of maternal behaviour will be measured using the Maternal Behavior Q-Sort (MBQS) Brief Version	The MBQS Brief Version is composed of 25 items and will be used by researchers to assess the sensitivity of maternal behaviour from a 10-minute in vivo mother-child interaction.	Change from pre-intervention to 12 months after engagement and 24 months after engagement
Maternal stress will be measured using the Parenting Stress Index Short Form (PSI-4-SF)	The PSI-4-SF consists of 36 items. All domains (Parent Distress, Difficult Child, and Parent-Child Dysfunctional Interaction) and the Total Stress Scale have acceptable reliability and validity.	Change from pre-intervention to 12 months after engagement and 24 months after engagement
Parenting attitudes will be measured using the Adult-Adolescent Parenting Inventory Version 2.0 (AAPI-2)	The AAPI-2 is composed of 40 items and will be used to assess parenting attitudes related to expectations, empathy, and discipline.	Change from pre-intervention to 12 months after engagement and 24 months after engagement
Self-efficacy and satisfaction as a parent will be measured using the Being a Parent Scale	The Being a Parent Scale consists of 16 items.	Change from pre-intervention to 12 months after engagement and 24 months after engagement
Quality and quantity of stimulation available to the child will be measured using the Home Observation for Measurement of the Environment Inventory (HOME)	The HOME is a 45-item questionnaire designed to measure the quality and quantity of stimulation available to young children.	Change from pre-intervention to 12 months after engagement and 24 months after engagement
Maternal depression will be measured using the Center for Epidemiological Studies Depression Scale (CES-D)	The CES-D consists of 20 items.	Change from pre-intervention to 12 months after engagement and 24 months after engagement
Maternal anxiety will be measured using the Beck Anxiety Inventory (BAI)	The BAI consists of 21 items.	Change from pre-intervention to 12 months after engagement and 24 months after engagement
Maternal adverse childhood experiences (ACEs) will be measured using a Maternal ACEs Measure (Felitti et al., 1998; Dube et al., 2003)	This 10-item questionnaire requires mothers to retrospectively report on their ACEs prior to 18 years of age. The questions pertain to abuse, neglect, and household dysfunction.	Change from pre-intervention to 12 months after engagement and 24 months after engagement
Maternal anxiety will be measured using the Generalized Anxiety Disorder Scale (GAD-7)	The GAD-7 consists of 7 items.	Change from pre-intervention to 12 months after engagement and 24 months after engagement
Maternal depression will be measured using the Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 consists of 9 items.	Change from pre-intervention to 12 months after engagement and 24 months after engagement

Collaborators and Investigators

• Sponsor: University of Ottawa

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: H-02-23-8940

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No