Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07168642

A Type I Hybrid Effectiveness-Implementation Trial of MIO

Led by Baystate Medical Center · Updated on 2026-01-07

200

Participants Needed

1

Research Sites

188 weeks

Total Duration

On this page

Sponsors

B

Baystate Medical Center

Lead Sponsor

B

Behavioral Health Network

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

A Type I Hybrid Effectiveness-Implementation Trial of MIO

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Identifies as a woman
  • English-speaking
  • Age 18 years or older
  • Enrolled in outpatient substance use treatment for a substance use disorder at one of the four target clinics
  • Caring for at least one child between 0 and 60 months of age (guardian or working towards reunification with regular contact)
  • Child is 5 years old or younger and in biological mother's custody or with family aiming for reunification with permission from legal guardian
  • Employed as an addiction counselor at a participating agency if counselor subject
  • Have a bachelor's degree or higher in psychology, social work, counseling, or related field if counselor subject
  • Secure approval for supervision and MIO delivery time commitments if counselor subject
  • Willing to have counseling and supervision sessions recorded if counselor subject
  • Receive mean score greater than 4 on Clinical Reflective Functioning Scale if counselor subject
  • Capable of managing counselor responsibilities as deemed by supervisors
  • Employment at participating agency for at least 3 months if agency staff subject
  • Willingness to complete questionnaires and participate in interviews or focus groups if agency staff subject
  • Fluency in English if agency staff subject
Not Eligible

You will not qualify if you...

  • Severe mental health problems (e.g., actively suicidal, homicidal, psychosis)
  • Severe cognitive impairment
  • Psychiatric or substance-related symptoms requiring inpatient hospitalization or ambulatory detoxification
  • Unable to speak English
  • Child with severe medical condition limiting interaction with mother (e.g., paralysis, severe weakness)
  • Child welfare custody with no goal of reunification with biological mother

AI-Screening

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Trial Site Locations

Total: 1 location

1

Baystate Medical Center

Springfield, Massachusetts, United States, 01199

Actively Recruiting

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Research Team

E

Elizabeth Peacock-Chambers, MD, MSc

CONTACT

B

Briana L Jurkowski, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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