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

Primary Purpose

Mother-Child Relations, Substance Use

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Breaking the Cycle Program
Maxxine Wright Program
Sponsored by
University of Ottawa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mother-Child Relations

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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: -

Sites / Locations

  • Maxxine Wright Community Health Centre
  • Mothercraft, Breaking the Cycle

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Breaking the Cycle Intervention group

Maxxine Wright Intervention group

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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.
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.
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.
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.
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.
Maternal depression will be measured using the Center for Epidemiological Studies Depression Scale (CES-D)
The CES-D consists of 20 items.
Maternal anxiety will be measured using the Beck Anxiety Inventory (BAI)
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)
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.

Full Information

First Posted
February 23, 2023
Last Updated
July 7, 2023
Sponsor
University of Ottawa
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1. Study Identification

Unique Protocol Identification Number
NCT05768815
Brief Title
Optimizing Mental Health for Infants Exposed to Early Adversity: A Comparison of Breaking the Cycle and Maxxine Wright
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ottawa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mother-Child Relations, Substance Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breaking the Cycle Intervention group
Arm Type
Experimental
Arm Title
Maxxine Wright Intervention group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Breaking the Cycle Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Maxxine Wright Program
Intervention Description
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).
Primary Outcome Measure Information:
Title
Children's socio-emotional functioning will be measured using the Ages and Stages Questionnaire-Social Emotional (ASQ-SE-2)
Description
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.
Time Frame
Change from pre-intervention to 12 months after engagement and 24 months after engagement
Title
Children's developmental functioning will be measured using the Ages and Stages Questionnaire-Third Edition (ASQ-3)
Description
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.
Time Frame
Change from pre-intervention to 12 months after engagement and 24 months after engagement
Secondary Outcome Measure Information:
Title
Children's exposure to risk and protective factors will be measured using a cumulative risk measure (Bondi et al., 2020)
Description
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).
Time Frame
Change from pre-intervention to 12 months after engagement and 24 months after engagement
Title
Sensitivity of maternal behaviour will be measured using the Maternal Behavior Q-Sort (MBQS) Brief Version
Description
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.
Time Frame
Change from pre-intervention to 12 months after engagement and 24 months after engagement
Title
Maternal stress will be measured using the Parenting Stress Index Short Form (PSI-4-SF)
Description
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.
Time Frame
Change from pre-intervention to 12 months after engagement and 24 months after engagement
Title
Parenting attitudes will be measured using the Adult-Adolescent Parenting Inventory Version 2.0 (AAPI-2)
Description
The AAPI-2 is composed of 40 items and will be used to assess parenting attitudes related to expectations, empathy, and discipline.
Time Frame
Change from pre-intervention to 12 months after engagement and 24 months after engagement
Title
Self-efficacy and satisfaction as a parent will be measured using the Being a Parent Scale
Description
The Being a Parent Scale consists of 16 items.
Time Frame
Change from pre-intervention to 12 months after engagement and 24 months after engagement
Title
Quality and quantity of stimulation available to the child will be measured using the Home Observation for Measurement of the Environment Inventory (HOME)
Description
The HOME is a 45-item questionnaire designed to measure the quality and quantity of stimulation available to young children.
Time Frame
Change from pre-intervention to 12 months after engagement and 24 months after engagement
Title
Maternal depression will be measured using the Center for Epidemiological Studies Depression Scale (CES-D)
Description
The CES-D consists of 20 items.
Time Frame
Change from pre-intervention to 12 months after engagement and 24 months after engagement
Title
Maternal anxiety will be measured using the Beck Anxiety Inventory (BAI)
Description
The BAI consists of 21 items.
Time Frame
Change from pre-intervention to 12 months after engagement and 24 months after engagement
Title
Maternal adverse childhood experiences (ACEs) will be measured using a Maternal ACEs Measure (Felitti et al., 1998; Dube et al., 2003)
Description
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.
Time Frame
Change from pre-intervention to 12 months after engagement and 24 months after engagement

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Racine, PhD, C.Psych
Phone
403-992-7869
Email
nracine2@uottawa.ca
Facility Information:
Facility Name
Maxxine Wright Community Health Centre
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1H9
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Penaloza
Email
denise.penaloza@fraserhealth.ca
Facility Name
Mothercraft, Breaking the Cycle
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5A 1L3
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Leslie
Phone
416-364-7373
Ext
3204
Email
margaret.leslie@mothercraft.org

12. IPD Sharing Statement

Learn more about this trial

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

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