Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05768815
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2023-02-23
Brief Title:
Optimizing Mental Health for Infants Exposed to Early Adversity A Comparison of Breaking the Cycle and Maxxine Wright
Sponsor:
University of Ottawa
Organization:
University of Ottawa
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childrens 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
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 childrens 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None