Optimizing Mental Health for Infants Exposed to Early Adversity: A Comparison of Breaking the Cycle and Maxxine Wright
- Conditions
- Substance UseMother-Child Relations
- Interventions
- Behavioral: Breaking the Cycle ProgramBehavioral: Maxxine Wright Program
- Registration Number
- NCT05768815
- Lead Sponsor
- University of Ottawa
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 100
- receiving services at either BTC or MW
- having a child under the age of 6 years
- being able to answer a questionnaire in English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Breaking the Cycle Intervention group Breaking the Cycle Program - Maxxine Wright Intervention group Maxxine Wright Program -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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.
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.
Maternal anxiety will be measured using the Generalized Anxiety Disorder Scale (GAD-7) Change from pre-intervention to 12 months after engagement and 24 months after engagement The GAD-7 consists of 7 items.
Maternal depression will be measured using the Patient Health Questionnaire-9 (PHQ-9) Change from pre-intervention to 12 months after engagement and 24 months after engagement The PHQ-9 consists of 9 items.
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 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.
Trial Locations
- Locations (2)
Maxxine Wright Community Health Centre
🇨🇦Surrey, British Columbia, Canada
Mothercraft, Breaking the Cycle
🇨🇦Toronto, Ontario, Canada