New therapy aims to help mothers in recovery connect with their kids
NCT ID NCT07168642
First seen Jun 24, 2026 · Last updated Jul 09, 2026 · Updated 3 times
Summary
This study tests a therapy called Mothering from the Inside Out (MIO) for mothers recovering from substance use disorders. The goal is to help them build stronger relationships with their young children and reduce parenting stress. Researchers will enroll 200 mothers from outpatient treatment programs and measure changes in parenting skills and mother-child interactions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mothering from the Inside Out (MIO) psychotherapy
- What this could lead to
- If it works, this could provide a proven therapy to help mothers in recovery improve their relationships with their children and reduce parenting stress.
- What could go wrong
- This is a mid-stage trial testing real-world effectiveness, so results may vary across settings. The therapy requires commitment and may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Client Subjects Inclusion Criteria: * 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) Exclusion Criteria: * 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 Inclusion Criteria: * 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 Exclusion Criteria: •In child welfare custody and goal is not reunification with biological mother Counselor Subjects Inclusion Criteria: * 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 Exclusion Criteria: •None Agency Staff Subjects Inclusion Criteria: * 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 Criteria: •None
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baystate Medical Center
RECRUITINGSpringfield, Massachusetts, 01199, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a trip to the pediatrician help teens beat opioid addiction?
- Can a unified therapy tame both addiction and emotional disorders?