Mother-Child RelationsNCT05768815
Optimizing Mental Health for Infants Exposed to Early Adversity: A Comparison of Breaking the Cycle and Maxxine Wright
A study testing Breaking the Cycle Program and Maxxine Wright Program in people with Mother-Child Relations and Substance Use, run by University of Ottawa at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Mother-Child Relations, Substance Use
- What is being tested?
- Breaking the Cycle Program and Maxxine Wright Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- 28 Sep 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- receiving services at either BTC or MW
- having a child under the age of 6 years
- being able to answer a questionnaire in English
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Maxxine Wright Community Health Centre
Surrey, British Columbia, V3V 1H9
Denise Penaloza, denise.penaloza@fraserhealth.ca
- Recruiting
Mothercraft, Breaking the Cycle
Toronto, Ontario, M5A 1L3
Mary Motz, 416-364-7373, mary.motz@mothercraft.org
About this study
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
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?
Read more
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
- Being tested
- Breaking the Cycle Program, Maxxine Wright Program
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breaking the Cycle ProgramBehavioural
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 ProgramBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Breaking the Cycle Intervention group | Experimental | Not described Receives: Behavioral: Breaking the Cycle Program |
| Maxxine Wright Intervention group | Active comparator | Not described Receives: Behavioral: Maxxine Wright Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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).
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
The AAPI-2 is composed of 40 items and will be used to assess parenting attitudes related to expectations, empathy, and discipline.
Measured: 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
The Being a Parent Scale consists of 16 items.
Measured: 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)
The HOME is a 45-item questionnaire designed to measure the quality and quantity of stimulation available to young children.
Measured: 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)
The CES-D consists of 20 items.
Measured: 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)
The BAI consists of 21 items.
Measured: 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)
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.
Measured: Change from pre-intervention to 12 months after engagement and 24 months after engagement
Maternal anxiety will be measured using the Generalized Anxiety Disorder Scale (GAD-7)
The GAD-7 consists of 7 items.
Measured: Change from pre-intervention to 12 months after engagement and 24 months after engagement
Maternal depression will be measured using the Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 consists of 9 items.
Measured: Change from pre-intervention to 12 months after engagement and 24 months after engagement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start28 Sep 2023
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mother-Child RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768815
- Sponsor's protocol ID
- H-02-23-8940
- Status last verified
- Mar 2024
- First submitted
- 23 Feb 2023
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38183089
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05768815
- Acronym / sponsor ID
- H-02-23-8940
- Conditions
- Mother-Child Relations, Substance Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breaking the Cycle Intervention group | Experimental | Behavioral: Breaking the Cycle Program |
| Maxxine Wright Intervention group | Active comparator | Behavioral: Maxxine Wright Program |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- receiving services at either BTC or MW
- having a child under the age of 6 years
- being able to answer a questionnaire in English
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breaking the Cycle ProgramBTC 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. | Behavioural | Breaking the Cycle Intervention group |
| Maxxine Wright ProgramFounded 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). | Behavioural | Maxxine Wright Intervention group |
Primary outcome
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.
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.
11 secondary outcomes
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
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
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
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
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
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
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
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
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
Maternal anxiety will be measured using the Generalized Anxiety Disorder Scale (GAD-7)
Time frame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
Maternal depression will be measured using the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Derived from this study: PubMed 38183089Racine 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breaking the Cycle Program and Maxxine Wright Program in people with Mother-Child Relations and Substance Use, run by University of Ottawa at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Racine, PhD, C.Psych (403-992-7869, nracine2@uottawa.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05768815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.