- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05768815
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
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
-
-
British Columbia
-
Surrey, British Columbia, Canada, V3V 1H9
- Not yet 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:
- Margaret Leslie
- Phone Number: 3204 416-364-7373
- Email: margaret.leslie@mothercraft.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Breaking the Cycle Intervention group
|
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
|
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)
Time Frame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
|
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)
Time Frame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
|
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)
Time Frame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
|
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
Time Frame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
|
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)
Time Frame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
|
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)
Time Frame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
|
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
Time Frame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
|
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)
Time Frame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
|
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)
Time Frame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
|
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)
Time Frame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
|
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)
Time Frame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-02-23-8940
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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