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A Type I Hybrid Effectiveness-Implementation Trial of "Mothering from the Inside Out" (MIO)

Award Number: R01DA058125
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2024
PERIOD OF PERFORMANCE END DATE: 07/31/2029

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A Type I Hybrid Effectiveness-Implementation Trial of "Mothering from the Inside Out" (MIO) - Project Summary/Abstract Mothers with substance use disorders (SUDs) face unique challenges with respect to the intersection of parenting and recovery. For this reason, they rarely benefit from evidence-based parenting interventions that have been brought to scale with the general public or child behavioral problems in mind. A different approach is needed. Mothering from the Inside Out (MIO) is the first attachment-based parenting intervention for mothers with SUDs that targets parental reflective functioning (RF). Parental RF is the capacity to (a) identify and regulate emotions that are activated during stressful parenting situations and (b) accurately recognize and understand young children’s need for stability, security, and sensitivity in the mother-child relationship. MIO has been shown to have bigenerational benefit by improving parental RF, maternal caregiving, and children’s attachment security while also reducing maternal psychiatric distress and relapse to substance use when delivered by researchers in randomized clinical trials with mothers enrolled in outpatient substance use treatment. However, in the third community-based efficacy trial when delivered by SUD treatment counselors, MIO was not associated with the same magnitude of improvement in RF or caregiving behaviors, raising important questions about the science-to-service gap. There remains a critical need to understand the implementation factors that may be related to enhanced treatment outcomes for MIO when delivered under ‘real-world’ conditions. Therefore, we propose to test MIO’s effectiveness when delivered in four substance use treatment programs where responsibility for MIO training and delivery will be assumed by community-based treatment providers. We also propose to conduct an implementation evaluation to examine key implementation constructs when integrated in four outpatient SUD treatment clinics. In this Type I hybrid effectiveness- implementation study, we will (a) conduct a randomized effectiveness trial where 200 mothers will be randomized to receive MIO plus standard outpatient SUD services versus standard outpatient SUD services alone; (b) replicate testing of the MIO mechanism of change with a larger cohort of counselors and clients; and (c) assess the impact of key implementation constructs on real-world delivery of MIO. Data collected in the effectiveness trial and the implementation evaluation will allow us to test causal effects and mechanisms of change within MIO under natural conditions while also gaining greater understanding of the implementation process to guide future large-scale implementation and dissemination projects. MIO has demonstrated the potential to interrupt a pernicious cycle involving the disruption of early attachment relationships that represents risk for the health of both mother and child. This Type I hybrid effectiveness-implementation study will accelerate our progress in bringing MIO to scale while ensuring continued methodological rigor aimed at optimizing treatment outcomes under real-world conditions.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $764,376 )
2025	2025	BAYSTATE MEDICAL CENTER, INC.	759 CHESTNUT STREET	SPRINGFIELD	MA	01199	HAMPDEN	USA	Drug Use and Addiction Research Programs	001	2	8/14/2025	NON-COMPETING CONTINUATION	$717,691
2025	2024	BAYSTATE MEDICAL CENTER, INC.	759 CHESTNUT STREET	SPRINGFIELD	MA	01199	HAMPDEN	USA	Drug Use and Addiction Research Programs	000	1	11/25/2024	NEW	$46,685
														Subtotal = $764,376

Issue Date FY: 2024 ( Subtotal = $708,891 )
2024	2024	BAYSTATE MEDICAL CENTER, INC.	759 CHESTNUT STREET	SPRINGFIELD	MA	01199	HAMPDEN	USA	Drug Use and Addiction Research Programs	000	1	9/17/2024	NEW	$708,891
														Subtotal = $708,891

Grand Total All Awards = $1,473,267

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A Type I Hybrid Effectiveness-Implementation Trial of "Mothering from the Inside Out" (MIO)

Award Number: R01DA058125

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/30/2024

PERIOD OF PERFORMANCE END DATE: 07/31/2029

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