Mothering from the Inside Out (MIO) for mothers in recovery from substance use
Official title: A Type I Hybrid Effectiveness-Implementation Trial of Mothering From the Inside Out (MIO)
Run by Baystate Medical Center · NCT07168642 · Data updated 2026-11-12
This will test whether the Mothering from the Inside Out (MIO) parenting program helps mothers in outpatient treatment for substance use disorder improve parenting and support recovery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Baystate Medical Center Academic / other |
| Locations | 1 site (Springfield, Massachusetts) |
| Status | Recruiting |
| Started | December 23, 2025 |
| Main results expected | March 30, 2029 |
| Study ends | July 31, 2029 |
| Registry record updated | July 8, 2026 |
| Trial ID | NCT07168642 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are English-speaking women aged 18 or older who are enrolled in outpatient treatment for a substance use disorder and who are caring for or working toward reunification with at least one child aged 0–60 months.
✕Probably not a fit
Patients with severe active mental illness, severe cognitive impairment, those requiring inpatient detoxification or hospitalization, non-English speakers, or mothers whose target child has a medical condition that prevents interaction are unlikely to be eligible or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Mothering from the Inside Out (MIO) is an attachment-focused, individual parenting program that targets parental reflective functioning among mothers with substance use disorders. This Type I hybrid effectiveness–implementation trial will test MIO as an adjunct to outpatient substance use treatment under real-world conditions across four participating clinics. The trial measures clinical outcomes—such as parenting capacities, maternal substance use, and parent–child interaction—alongside implementation outcomes and barriers to uptake. Results will inform how MIO can be delivered in routine community treatment settings and what supports are needed for wider dissemination.
Why it matters
Potential benefit: If successful, MIO could improve mothers' parenting skills, reduce substance use relapse, and support better developmental outcomes for young children.
How similar studies have gone: Previous randomized trials delivered by expert clinicians showed that MIO improved parenting capacities and reduced substance use compared with parental education, although those trials were conducted in tightly controlled research settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Client Subjects Inclusion Criteria: * 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 Criteria: * 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 Exclusion Criteria: •In child welfare custody and goal is not reunification with biological mother Counselor Subjects Inclusion Criteria: * Age 21 years or older * Employed as an addiction counselor at one of the participating agencies in one of the target clinics * Have a bachelor's degree or higher in psychology, social work, counseling, or a related field * Have secure administrative approval for a 1-hour per biweekly commitment to supervision and 2-3 hours weekly for MIO delivery * Do not intend to give notice and are not scheduled for medical or family leave during the study period * Willing to have counseling and supervision sessions recorded * Receive a mean score greater than 4 on the Clinical Reflective Functioning Scale * Are deemed capable to manage the responsibilities of being a counselor in a randomized trial (deliver MIO promptly to participants, compliant with study procedures and assessments, willing to receive supervision) by their supervisors Exclusion Criteria: •None Agency Staff Subjects Inclusion Criteria: * Employment at a participating agency for at least 3 months * Willingness to complete questionnaires and participate in a confidential interview or focus group * Fluency in English Exclusion Criteria: •None
Where it's running
-
Baystate Medical Center
Springfield, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Elizabeth Peacock-Chambers, MD, MSc
- Email: elizabeth.peacock-chambers@baystatehealth.org
- Phone: 413-794-8301
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.