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

Sponsor

University of Ottawa (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05768815

Collaborator

(none)

100

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mother-Child Relations Substance Use	Behavioral: Breaking the Cycle Program Behavioral: Maxxine Wright Program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2026

Anticipated Study Completion Date :

Aug 1, 2026

Arms and Interventions

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 (MW) 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).

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 (MW) 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).

Outcome Measures

Primary Outcome Measures

Children's socio-emotional functioning will be measured using the Ages and Stages Questionnaire-Social Emotional (ASQ-SE-2) [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.
Children's developmental functioning will be measured using the Ages and Stages Questionnaire-Third Edition (ASQ-3) [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.

Secondary Outcome Measures

Children's exposure to risk and protective factors will be measured using a cumulative risk measure (Bondi et al., 2020) [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).
Sensitivity of maternal behaviour will be measured using the Maternal Behavior Q-Sort (MBQS) Brief Version [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.
Maternal stress will be measured using the Parenting Stress Index Short Form (PSI-4-SF) [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.
Parenting attitudes will be measured using the Adult-Adolescent Parenting Inventory Version 2.0 (AAPI-2) [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.
Self-efficacy and satisfaction as a parent will be measured using the Being a Parent Scale [Change from pre-intervention to 12 months after engagement and 24 months after engagement]
The Being a Parent Scale consists of 16 items.
Quality and quantity of stimulation available to the child will be measured using the Home Observation for Measurement of the Environment Inventory (HOME) [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.
Maternal depression will be measured using the Center for Epidemiological Studies Depression Scale (CES-D) [Change from pre-intervention to 12 months after engagement and 24 months after engagement]
The CES-D consists of 20 items.
Maternal anxiety will be measured using the Beck Anxiety Inventory (BAI) [Change from pre-intervention to 12 months after engagement and 24 months after engagement]
The BAI consists of 21 items.
Maternal adverse childhood experiences (ACEs) will be measured using a Maternal ACEs Measure (Felitti et al., 1998; Dube et al., 2003) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maxxine Wright Community Health Centre	Surrey	British Columbia	Canada	V3V 1H9
2	Mothercraft, Breaking the Cycle	Toronto	Ontario	Canada	M5A 1L3

Sponsors and Collaborators

University of Ottawa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Ottawa

ClinicalTrials.gov Identifier:

NCT05768815

Other Study ID Numbers:

H-02-23-8940

First Posted:

Mar 14, 2023

Last Update Posted:

Mar 14, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Substance-Related Disorders

Study Results

No Results Posted as of Mar 14, 2023