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New program aims to prevent depression in parents of down syndrome babies

NCT ID NCT07469176

Knowledge-focused Sponsor: Northwestern University 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 This study
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 16, 2026 · Updated 4 times

Summary

This study is testing a program called Mothers and Babies for Down Syndrome (MBDS) to help prevent depression in new and expectant parents of infants with Down syndrome. About 72 parents will take part in a small pilot study to see if the program helps with feelings of grief and improves social support. The goal is to prepare for a larger study that could help many 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 72 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age 18 years or older * Expecting or parenting an infant with Down Syndrome (20 months gestation - 4 months old) * Speaks and Reads English * Has access to internet and videoconferencing Exclusion Criteria: -active suicidal ideation (indicated on the screener) Withdrawal criteria: * Active suicide ideation indicated on any of the following: endorsement of BDI-II item 9, PHQ-9 item 9; PGS-Diagnosis item 3 Subscale II; statements to research staff); or * BDI-II total score ranging from 20 - 63 indicating the participant endorses moderate to severe depressive symptoms and has a higher need for mental health services.

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder Down syndrome perinatal asphyxia prevention target

As listed by the trial registrant

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

Depression

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Northwestern University

    Chicago, Illinois, 60302, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.