A Type I Hybrid Effectiveness-Implementation Trial of MIO

NCT07168642 | Recruiting DMC

• 1 other identifier: BH-25-127
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Parental Reflective Functioning

  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.

  Baseline, post treatment (week 21)

• Parental Reflective Functioning

  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.

  Baseline, post treatment (week 21)

• Parenting Stress

  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.

  Baseline, during treatment (week 13), post treatment (week 21), follow-up (week 33)

Secondary Outcomes (9)

• Quality of mother-child interaction

  Baseline, follow-up (week 33)

• Substance Use

  Baseline, monthly during weeks 1-21, post treatment (week 21)

• Substance Use

  Baseline, during treatment (week 13), post treatment (week 21), follow-up (week 33)

• Anxiety

  Baseline, during treatment (week 13), post treatment (week 21)

• Depression

  Baseline, during treatment (week 13), post treatment (week 21)

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Mothering from the Inside Out

Control

NO INTERVENTION

Treatment as usual (TAU)

Interventions

Mothering from the Inside Out BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Parents that identify as mothers
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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
• In child welfare custody and goal is not reunification with biological mother
• Counselor Subjects
• 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

Sponsors & Collaborators

• Baystate Medical Center: lead
• Behavioral Health Network: collaborator
• Spectrum Health Systems: collaborator

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

RECRUITING

Related Publications (1)

• Lowell AF, Peacock-Chambers E, Zayde A, DeCoste CL, McMahon TJ, Suchman NE. Mothering from the Inside Out: Addressing the Intersection of Addiction, Adversity, and Attachment with Evidence-Based Parenting Intervention. Curr Addict Rep. 2021;8(4):605-615. doi: 10.1007/s40429-021-00389-1. Epub 2021 Jul 15.

  PMID: 34306964 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Elizabeth Peacock-Chambers, MD, MSc

CONTACT

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

Briana L Jurkowski, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics, Division Chief of Health and Behavior

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: September 11, 2025
• Study Start: December 18, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)