Clinical trial NCT05768815: 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
Overall status: RECRUITING
Phase: NA
Conditions: Mother-Child Relations
Substance Use
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

-

Primary outcomes:
measure: Children's socio-emotional functioning will be measured using the Ages and Stages Questionnaire-Social Emotional (ASQ-SE-2)
timeFrame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
measure: Children's developmental functioning will be measured using the Ages and Stages Questionnaire-Third Edition (ASQ-3)
timeFrame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
Secondary outcomes:
measure: Children's exposure to risk and protective factors will be measured using a cumulative risk measure (Bondi et al., 2020)
timeFrame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
measure: Sensitivity of maternal behaviour will be measured using the Maternal Behavior Q-Sort (MBQS) Brief Version
timeFrame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
measure: Maternal stress will be measured using the Parenting Stress Index Short Form (PSI-4-SF)
timeFrame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
measure: Parenting attitudes will be measured using the Adult-Adolescent Parenting Inventory Version 2.0 (AAPI-2)
timeFrame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
measure: Self-efficacy and satisfaction as a parent will be measured using the Being a Parent Scale
timeFrame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
measure: Quality and quantity of stimulation available to the child will be measured using the Home Observation for Measurement of the Environment Inventory (HOME)
timeFrame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
measure: Maternal depression will be measured using the Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
measure: Maternal anxiety will be measured using the Beck Anxiety Inventory (BAI)
timeFrame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
measure: Maternal adverse childhood experiences (ACEs) will be measured using a Maternal ACEs Measure (Felitti et al., 1998; Dube et al., 2003)
timeFrame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
measure: Maternal anxiety will be measured using the Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
measure: Maternal depression will be measured using the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change from pre-intervention to 12 months after engagement and 24 months after engagement
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Maxxine Wright Community Health Centre
state: British Columbia
city: Toronto
country: Canada
facility: Mothercraft, Breaking the Cycle
state: Ontario
Study officials:
References: