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

Официальное название

Optimizing Mental Health for Infants Exposed to Early Adversity: A Comparative Effectiveness Trial of the Breaking the Cycle and Maxxine Wright Intervention Programs

Обзор

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.

Вмешательства

• Поведенческое Breaking the Cycle Program
  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
• Поведенческое Maxxine Wright Program
  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 Re

Первичные конечные точки

• Children's socio-emotional functioning will be measured using the Ages and Stages Questionnaire-Social Emotional (ASQ-SE-2) [Срок оценки: 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) [Срок оценки: Change from pre-intervention to 12 months after engagement and 24 months after engagement]

Вторичные конечные точки (11)

• Children's exposure to risk and protective factors will be measured using a cumulative risk measure (Bondi et al., 2020) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Change from pre-intervention to 12 months after engagement and 24 months after engagement]

Критерии участия

Критерии включения

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

Критерии исключения

\-

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 2 центра

• Maxxine Wright Community Health Centre — Surrey
• Mothercraft, Breaking the Cycle — Toronto

Публикации

• 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

Идентификаторы

NCT: NCT05768815 · H-02-23-8940

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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