Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID07168642

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

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

200

Participants Needed

1

Research Sites

25 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 recovering from substance use disorders face unique challenges balancing parenting with maintaining their own recovery. This research evaluates the Mothering from the Inside Out (MIO) intervention, an attachment-based parenting program designed specifically to support mothers in recovery. The study aims to test MIO's effectiveness in outpatient treatment settings, examine how well it can be implemented in different clinics, and identify factors that help with wider adoption. This addresses a critical gap in care for mothers with substance use disorders and their children. Participants will be randomly assigned in a 2:1 ratio to receive either MIO combined with usual treatment or usual treatment alone. MIO is an individual psychotherapy that helps mothers better understand their own and their children's feelings and behaviors through a supportive, reflective approach. The study will involve 200 mothers caring for children aged 0 to 5 years, recruited from four community clinics. The intervention period spans 21 weeks, followed by assessments at 13 weeks, post-treatment at 21 weeks, and follow-up at 33 weeks. Throughout the study, mothers will complete various assessments including measures of parental reflective functioning, parenting stress, quality of mother-child interactions, substance use, and mental health symptoms like anxiety and depression. Implementation factors such as treatment fidelity and feasibility will also be evaluated. Data collection includes baseline, during treatment, post-treatment, and follow-up visits, ensuring comprehensive monitoring of both clinical outcomes and how well the intervention is delivered. The total study period extends to 33 weeks per participant with ongoing evaluation of organizational and counselor-related factors.

CONDITIONS

Brief 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
  • Speaks English
  • Age 18 years or older
  • Enrolled in outpatient substance use disorder treatment at one of the four target clinics
  • Caring for at least one child aged 0 to 60 months as guardian or working towards reunification
  • Child is 5 years or younger and in custody of biological mother or family with permission for study participation
  • Addiction counselors aged 21 or older employed at participating agencies with required qualifications and commitments
  • Agency staff employed for at least 3 months and willing to participate in study activities
Not Eligible

You will not qualify if you...

  • Severe mental health problems such as active suicidal thoughts, homicidal behavior, or psychosis
  • Severe cognitive impairment
  • Psychiatric or substance-related symptoms requiring inpatient hospitalization or detoxification
  • Unable to speak English
  • Target child has severe medical conditions limiting interaction with mother
  • Child welfare custody without goal of reunification with biological mother
  • No exclusion criteria for counselors or agency staff

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 21 weeks

Participants receive Mothering from the Inside Out (MIO) psychotherapy alongside their standard substance use disorder treatment, focusing on enhancing parental reflective functioning and parenting skills.

Weekly visits for up to 21 weeks

Follow-up

Duration - 12 weeks

Participants are monitored to assess sustained improvements in parenting, substance use, and mental health after treatment ends.

1 visit (in-person) at week 33

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

B

Briana L Jurkowski, BS

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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Published Research Related To This Trial

Mothering from the Inside Out: Addressing the Intersection of Addiction, Adversity, and Attachment with Evidence-Based Parenting Intervention.

Amanda F Lowell, Elizabeth Peacock-Chambers, Amanda Zayde...

https://pubmed.ncbi.nlm.nih.gov/34306964