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

Substance Use Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05768815
• Other study ID #: H-02-23-8940
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2023
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: University of Ottawa
• Contact: Nicole Racine, PhD, C.Psych
• Phone: 403-992-7869
• Email: nracine2[@]uottawa.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Mother-Child Relations
• Substance Use
• Substance-Related Disorders

Intervention

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.
• 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).

Locations

Country	Name	City	State
Canada	Maxxine Wright Community Health Centre	Surrey	British Columbia
Canada	Mothercraft, Breaking the Cycle	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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 ?ve domains for children 1 to 66 months: communication, gross motor, ?ne motor, problem-solving, and personal-social skills.	Change from pre-intervention to 12 months after engagement and 24 months after engagement
Secondary	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
Secondary	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
Secondary	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, Dif?cult 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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