Mothering from the Inside Out for Substance Use Disorder

Overseen By Briana L Jurkowski, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Baystate Medical Center

Disqualifiers: Severe mental health, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 33

Duration: 21 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help mothers recovering from substance use disorders improve their parenting skills. It will test a program called Mothering from the Inside Out (MIO), which focuses on building strong emotional bonds with children while managing recovery. The trial will compare the effectiveness of MIO combined with regular treatment to regular treatment alone. Mothers currently in outpatient treatment for substance use disorders and caring for young children might be a good fit.

As an unphased trial, this study offers mothers a unique opportunity to enhance parenting skills while supporting their recovery journey.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Mothering from the Inside Out intervention is safe for mothers with substance use disorders?

Research has shown that the Mothering from the Inside Out (MIO) program has been thoroughly studied in mothers dealing with substance use issues. Studies indicate that MIO improves the well-being of both mothers and their children, with no major safety concerns reported. Specifically, mothers in the program experienced less depression and gained a better understanding of their children's mental needs. These positive outcomes suggest that the program is safe and well-tolerated. While the studies emphasize the benefits, no specific reports of negative effects have emerged, supporting the safety of participating in this program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about "Mothering from the Inside Out" (MIO) because it focuses on strengthening the mother-child relationship as a way to address substance use disorder. Unlike standard treatments that often rely on medication or extensive therapy sessions targeting the individual, MIO integrates parenting-focused interventions to help mothers improve their caregiving skills while managing their recovery. This approach is unique because it considers the family dynamic as a critical element in recovery, potentially leading to more sustainable outcomes for both the mother and her child.

What evidence suggests that Mothering from the Inside Out is effective for substance use disorder?

Research has shown that "Mothering from the Inside Out" (MIO), which participants in this trial may receive, helps mothers with substance use issues. Studies found that mothers in MIO experienced less depression and better understood their children's feelings. This program focuses on building strong bonds and is designed for mothers in recovery, benefiting both them and their children. In several trials, community addiction counselors effectively taught MIO, improving parenting skills and aiding recovery. Overall, evidence suggests MIO can positively affect mothers and their children by enhancing mothers' mental health and parenting abilities. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for mothers with substance use disorders who are currently in outpatient treatment. It's designed to help them manage the stress of parenting while maintaining recovery. To participate, they must meet certain criteria that will be specified by the researchers.

Inclusion Criteria

Willing to have counseling and supervision sessions recorded (Counselor Subjects)

English-speaking

I am 18 years old or older.

Exclusion Criteria

Have severe mental health problems (e.g., actively suicidal, homicidal, psychosis)

Have psychiatric or substance-related symptoms requiring inpatient hospitalization or ambulatory detoxification

Unable to speak English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Mothering from the Inside Out (MIO) intervention alongside treatment as usual (TAU)

21 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Follow-up assessments at week 33

What Are the Treatments Tested in This Trial?

Interventions

• Mothering from the Inside Out

Trial Overview The trial is testing 'Mothering from the Inside Out' (MIO), an attachment-based parenting intervention tailored for mothers recovering from drug addiction. The study aims to evaluate its effectiveness in real-world settings and understand how best to implement it.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

Treatment as usual (TAU)

Who Is Running the Clinical Trial?

Baystate Medical Center

Lead Sponsor

Trials

67

Recruited

44,500+

Behavioral Health Network

Collaborator

Spectrum Health Systems

Collaborator

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36862381/

Mothering from the Inside Out: Results of a community-based ... This randomized clinical trial was designed to test the efficacy of MIO when delivered by community-based addiction counselors in Connecticut, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02955199

Stage III Community-based Efficacy Trial for Mothering ... Mothering from the Inside Out (MIO) is a 12 session individual parenting therapy designed for mothers enrolled in treatment for drug and/or alcohol addiction ...

3. motheringfromtheinsideout.org motheringfromtheinsideout.org/published-research

Services 4 — Mothering from the Inside Out Enhancing the effectiveness of residential treatment for substance abusing pregnant and parenting women: Focus on maternal reflective functioning and mother‐ ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/imhj.22043

Mothering from the Inside Out: Results of a community‐ ... Mothers who participated in MIO showed decreased certainty about their child's mental states, and decreased depression; their children ...

5. cebc4cw.org cebc4cw.org/program/mothering-from-the-inside-out/

CEBC » Program › Mothering From The Inside Out Mothering from the Inside Out (MIO) is a brief individual parenting intervention developed as an adjunct to substance use treatment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8280593/

Mothering from the Inside Out - PubMed Central - NIH Evidence from clinical trials suggests that MIO improves outcomes for two generations: both mothers with addictions and their children. Recent ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10050102/

Mothering from the Inside Out: Results of a community- ... Caregiving, psychiatric, and substance use outcomes were assessed repeatedly from baseline through 12-week follow-up. Mothers who participated in MIO showed ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07168642

A Type I Hybrid Effectiveness-Implementation Trial of MIO Mothering from the Inside Out (MIO) is an evidence-based, individual parenting intervention designed as an adjunct to outpatient SUD treatment that targets ...

9. researchgate.net researchgate.net/publication/317085851_Mothering_from_the_Inside_Out

(PDF) Mothering from the Inside Out Mothers with substance use disorders have demonstrated lower levels of sensitivity and responsiveness to their young children's emotional cues.