Clinical Trial

A Type I Hybrid Effectiveness-Implementation Trial of MIO

Recruiting
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Summary
Mothers with substance use disorders face unprecedented stress in their roles as parents working to care for their children while maintaining healthy recovery. Mothering from the Inside Out (MIO) is the first attachment-based parenting intervention designed specifically for mothers in recovery from substance use disorders that has been shown to have benefit for both mother and child in multiple randomized controlled trials. This project will: (a) test the effectiveness of MIO among women in outpatient treatment under 'real-world' conditions, (b) evaluate implementation in different settings, and (c) assess key implementation factors to support optimal uptake and treatment in future dissemination studies; closing an important science-to-service gap for an underserved population in an effort to support maternal and child health simultaneously.
Protocol Amendment History 1 change
notable Primary completion pushed: 2029-01-31 -> 2029-03-30 2026-07-09
Trial Details
NCT Number NCT07168642
Lead Sponsor Baystate Medical Center
Collaborators: Behavioral Health Network, Spectrum Health Systems
Conditions Substance Use Disorder
Enrollment 200 participants
Start Date 2025-12-23
Primary Completion 2029-03-30 (estimated)
Study Completion 2029-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-08