Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07168642

A Type I Hybrid Effectiveness-Implementation Trial of MIO

Sponsor: Baystate Medical Center

View on ClinicalTrials.gov

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.

Official title: A Type I Hybrid Effectiveness-Implementation Trial of Mothering From the Inside Out (MIO)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-12-18

Completion Date

2029-07-31

Last Updated

2026-01-07

Healthy Volunteers

Conditions

Substance Use Disorder

Interventions

BEHAVIORAL

Mothering from the Inside Out

Mothering from the Inside Out (MIO) is an evidence-based individual psychotherapy designed to help caregivers in recovery build stronger relationships with their children. In MIO, caregivers are helped to build their ability to reflect on their own mental states and how they arose. Often, we find that the thoughts and feelings that drive caregiving behavior are actually triggered by early experiences of being cared for. MIO thus aims to provide a safe, therapeutic space where caregivers' internal experiences are taken seriously and clinicians are genuinely interested, curious, and collaborative. MIO also involves helping caregivers to reflect on the possible mental states underlying their children's behavior. We find that by providing some information about child development through an attachment lens, this can help parents see through their children's eyes and feel less stressed.

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

Locations (1)

Baystate Medical Center

Springfield, Massachusetts, United States