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New Parent-Led therapy helps infants with down syndrome babble and talk sooner

NCT ID NCT06450509

Symptom relief Sponsor: Arizona State 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a program called Babble Boot Camp for infants with Down syndrome, who often start talking late. 60 babies under 12 months old took part. Parents were trained by a speech therapist via video calls to do simple activities at home to boost their child's speech and language skills. The goal was to see if starting this help early, before delays set in, could improve babbling and first words.

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

60 people

The number who actually took part.

Started

Feb 2024

Finished

Mar 2026

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

0 to 12 months

Sex

Anyone

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: * Full trisomy 21 * English is the main language spoken in the home Exclusion Criteria: * Partial or mosaic trisomy 21 * Any additional condition that could confound the findings * Awaiting heart surgery * Born prematurely before 34 weeks gestation

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Conditions

The condition(s) this trial relates to.

Down syndrome

As listed by the trial registrant

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

Down syndrome

Contacts and locations

Locations

  • Arizona State University

    Tempe, Arizona, 85287, United States

More trials for these conditions

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