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Mothering from the Inside Out (MIO) for Substance Use Disorder

This study is testing a therapy called Mothering from the Inside Out (MIO) for mothers recovering from substance use disorder. MIO is a type of individual counseling designed to help you build stronger relationships with your children by understanding your own thoughts and feelings better. Researchers want to see how well MIO works in real-world outpatient treatment settings and how easy it is to put into practice. They will measure how well mothers can reflect on their own and their child's mental states, and also look at parenting stress. This study is for women aged 18 or older who are fluent in English, are in outpatient substance use treatment, and are caring for a child between 0 and 60 months old. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 200 women. It is a Type I Hybrid Effectiveness-Implementation trial, meaning it tests both how well the intervention works and how well it can be put into practice.
What's involved
You would participate in the Mothering from the Inside Out (MIO) therapy. Your parental reflective functioning would be measured at the start and after 21 weeks, and parenting stress would be measured at the start, at 13 weeks, and at 21 weeks.
Compensation
Not stated in the trial record.
Follow-up
Parenting stress will be measured again at a follow-up appointment 33 weeks after the start of the study.

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NCT07168642

A Type I Hybrid Effectiveness-Implementation Trial of MIO

Recruiting
NAAges 18+InterventionalTreatment
Baystate Medical Center
~200 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:Mothering from the Inside Out

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Parental Reflective Functioning
Measured over Baseline, post treatment (week 21)
+2 more outcomes measured

Conditions

Substance Use Disorder

Explore related trials

Substance use disorder

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Elizabeth Peacock-Chambers, MD, MSc
[email protected]
413-794-8301
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)
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
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
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

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)

What this trial measures

  • Parental Reflective FunctioningBaseline, post treatment (week 21)

    The Parent Development Interview (PDI) is a semi-structured clinical interview with 19 questions intended to examine parents' representations of their children, themselves as parents, and their relationships with their children. The PDI is coded using an 11-point reflective functioning rating scale (-1 to 9) where higher score indicates higher reflective capacity.

  • Parental Reflective FunctioningBaseline, post treatment (week 21)

    The Parental Reflective Functioning Questionnaire (PRFQ) is an 18-item questionnaire assessing caregiver's capacity to reflect upon his/her own internal mental experiences as well as those of the child. Uses a 7-point Likert scale with 1 being "Completely disagree," 4 being "Neutral," and 7 being "Completely agree." Items 11 and 18 are reverse coded. Minimum score is 18, max is 126. High scores on this scale indicate serious distortions in parental reflective functioning.

  • Parenting StressBaseline, during treatment (week 13), post treatment (week 21), follow-up (week 33)

    The Parenting Stress Index-Short Form (PSI-SF) is a 36-item questionnaire used to assess parenting stress on a 5-point Likert scale. It's a briefer version of the full Parenting Stress Index, designed to be more efficient for clinical and research settings. The PSI-SF measures three key areas: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child, which together contribute to an overall measure of parenting stress, minimum score 36 and maximum 180. Scores at or above the 85th percentile on the Total Stress scale are considered to be borderline clinically significant.