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New therapy aims to keep families together amid substance use struggles

NCT ID NCT04294134

Disease control Sponsor: Children's Hospital of Philadelphia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a therapy program called MIO-CPP for mothers recovering from substance use disorders and their young children (up to age 5). The program combines individual therapy for mothers and joint mother-child sessions to strengthen their bond and improve child well-being. Researchers will enroll 320 mother-child dyads from residential treatment centers in Pennsylvania and track outcomes like parenting stress, child behavior, and child welfare involvement over 9 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MIO-CPP therapy (Mothering from the Inside Out and Child-Parent Psychotherapy) plus Certified Recovery Specialists
What this could lead to
If successful, this could provide an effective therapy model to help mothers in recovery build stronger bonds with their children and reduce the risk of child welfare involvement.
What could go wrong
This is a small, early-stage study with no control group, so results may not be generalizable. The therapy is intensive and may not work for all families.

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

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

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2020

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Women actively receiving treatment for Substance Use Disorder at one of three participating residential substance use disorder clinics in Philadelphia and Bucks Counties (Libertae Inc.; Gaudenzia's Hutchinson House; Gaudenzia Winner Program). 2. Must be at least six months pregnant or must have a child 5 years old or younger. 3. Must have access to child - children must either reside with mother, or, if the child is in foster/kinship care, the goal must be reunification. Exclusion Criteria: 1. Duration of affiliation with treatment center: Women will not be referred for enrollment before they have been affiliated with the treatment facility for at least 14 days and will not be referred if they are less than 45 days from discharge. These limitations will ensure that women are not referred to our study too quickly as they are adjusting to residential treatment, but will also ensure that we do not enroll women too soon before they are discharged from residential treatment. 2. Non-English Speaking The study will not enroll mothers who would be unable to receive the intervention services in English without the assistance of an interpreter. Due to the duration of the study intervention as well as the frequency of visits between the Child-Parent Specialist and the client, it would not be feasible to ensure that an interpreter would also be available for all visits.

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Conditions

The condition(s) this trial relates to.

substance-related disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parent child abuse Parent-child relations Substance use disorders

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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

  • Roberts Center for Pediatric Research

    Philadelphia, Pennsylvania, 19146, United States

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