NCT07168642 A Type I Hybrid Effectiveness-Implementation Trial of MIO
| NCT ID | NCT07168642 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baystate Medical Center |
| Condition | Substance Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-12-23 |
| Primary Completion | 2029-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-12-23 with a primary completion date of 2029-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07168642 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Substance Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07168642 currently recruiting?
Yes, NCT07168642 is actively recruiting participants. Contact the research team at elizabeth.peacock-chambers@baystatehealth.org for enrollment information.
Where is the NCT07168642 trial being conducted?
This trial is being conducted at Springfield, United States.
Who is sponsoring the NCT07168642 clinical trial?
NCT07168642 is sponsored by Baystate Medical Center. The trial plans to enroll 200 participants.