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

NCT05768815 | Recruiting

• 1 other identifier: H-02-23-8940
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Breaking the Cycle Intervention group

EXPERIMENTAL

Behavioral: Breaking the Cycle Program

Maxxine Wright Intervention group

ACTIVE COMPARATOR

Behavioral: Maxxine Wright Program

Interventions

Breaking the Cycle Program BEHAVIORAL

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.

Breaking the Cycle Intervention group

Maxxine Wright Program BEHAVIORAL

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).

Maxxine Wright Intervention group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• receiving services at either BTC or MW
• having a child under the age of 6 years
• being able to answer a questionnaire in English

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (2)

Maxxine Wright Community Health Centre

Surrey, British Columbia, V3V 1H9, Canada

RECRUITING

Mothercraft, Breaking the Cycle

Toronto, Ontario, M5A 1L3, Canada

RECRUITING

Related Publications (1)

• Racine N, Barriault S, Motz M, Leslie M, Poole N, Premji S, Andrews NCZ, Penaloza D, Pepler D. A comparative effectiveness study of the breaking the cycle and Maxxine Wright intervention programs for substance-involved mothers and their children: study protocol. BMC Psychol. 2024 Jan 5;12(1):16. doi: 10.1186/s40359-023-01484-w.

  PMID: 38183089 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Nicole Racine, PhD, C.Psych

CONTACT

403-992-7869; nracine2@uottawa.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 14, 2023
• Study Start: September 28, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 23, 2024

Record last verified: 2024-03

Locations

CA (2)