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

University of Ottawa

Status: Enrolling

Conditions: Substance Use; Mother-Child Relations

Treatments: Behavioral: Breaking the Cycle Program; Behavioral: Maxxine Wright Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05768815

H-02-23-8940

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Breaking the Cycle Intervention group

Experimental group

Treatment:

Behavioral: Breaking the Cycle Program

Maxxine Wright Intervention group

Active Comparator group

Treatment:

Behavioral: Maxxine Wright Program