Status:
RECRUITING
A Type I Hybrid Effectiveness-Implementation Trial of MIO
Lead Sponsor:
Baystate Medical Center
Collaborating Sponsors:
Behavioral Health Network
Spectrum Health Systems
Conditions:
Substance Use Disorder
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 t...
Detailed Description
Pregnancy and parenting can be life-changing motivators for women with substance use disorders (SUDs) to seek treatment. However, the rate of relapse and overdose for women with SUDs increases sharply...
Eligibility Criteria
Inclusion
- Client Subjects
- Identifies as a woman
- English-speaking
- Age 18 years or older
- Enrolled in outpatient substance use treatment for a substance use disorder (by DSMV criteria) at one of the four target clinics operated by participating agencies
- Caring for at least one child between 0 and 60 months of age (either as guardian or working towards reunification with regular contact)
Exclusion
- Have severe mental health problems (e.g., actively suicidal, homicidal, psychosis)
- Severely cognitively impaired
- Have psychiatric or substance-related symptoms requiring inpatient hospitalization or ambulatory detoxification
- Unable to speak English
- Have a potential target child who has a severe medical condition that limits their ability to interact with their mother (such as paralysis or severe weakness)
- Children Subjects
- Inclusion Criteria:
- Age 5 years or younger
- Are in their biological mother's custody OR are in custody of family with the goal of reunification with their biological mother and have permission from the child's legal guardian to participate in this study
Key Trial Info
Start Date :
December 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07168642
Start Date
December 18 2025
End Date
July 31 2029
Last Update
January 7 2026
Active Locations (1)
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1
Baystate Medical Center
Springfield, Massachusetts, United States, 01199