Recruiting

MIO

Sponsor:

Baystate Medical Center

Code:

NCT07168642

Conditions

Substance Use Disorder

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mothering from the Inside Out

Study Details

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.

Conditions

Substance Use Disorder

Study ID

NCT07168642

Start date

Dec 23, 2025

Status verified date

Jul, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Mar 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

Mothering from the Inside Out (MIO) + treatment as usual (TAU)

no intervention: Control

Treatment as usual (TAU)

Interventions

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.

Primary outcome measure

  • Parental Reflective Functioning [ Time Frame: Baseline, post treatment (week 21) ]
  • Parental Reflective Functioning [ Time Frame: Baseline, post treatment (week 21) ]
  • Parenting Stress [ Time Frame: Baseline, during treatment (week 13), post treatment (week 21), follow-up (week 33) ]

Central Contacts and Locations

Central contacts

Elizabeth Peacock-Chambers, MD, MSc

413-794-8301elizabeth.peacock-chambers@baystatehealth.org

Briana L Jurkowski, BS

413-794-8833briana.jurkowski@baystatehealth.org

Locations

Baystate Medical Center

Recruiting

Springfield, Massachusetts, United States, 01199

Contacts

Elizabeth Peacock-Chambers, MD, MS

413-794-8301elizabeth.peacock-chambers@baystatehealth.org

Briana L Jurkowski, BS

413-794-8833briana.jurkowski@baystatehealth.org

Principal Investigator:

Elizabeth Peacock-Chambers, MD, MS

More Information

Sponsor

Baystate Medical Center

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • substance use disorder
  • parenting
  • parenting intervention
  • Mothering from the Inside Out
  • MIO
  • SUD treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baystate Medical Center on 2026-07-08.