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Babble boot camp: could early talk therapy stop speech delays in rare disease?

NCT ID NCT03838016

Prevention Sponsor: Arizona State University Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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)
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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
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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This status has not been confirmed recently, so it may be out of date.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 babies with classic galactosemia, a rare condition that often causes speech and language problems. The program started when babies were 2 to 24 months old and involved weekly online coaching for parents from a speech therapist. The goal was to see if starting therapy before problems appear could prevent or reduce speech delays, compared to waiting until later.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

285 people

The number who actually took part.

Started

May 2019

Finished

Aug 2025

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

2 to 54 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: * Newborn diagnosis of classic galactosemia * Any ethnic or racial background * Primary language in the home is English * Any geographic region in the US and other countries because the intervention is done online * Computer and internet access (we can help if a family wants to participate but doesn't have this access) * At least one parent must have at least an 8th grade education to be able to fill out the questionnaires Exclusion Criteria: * Other forms of galactosemia outside of classic galactosemia * Medical, sensory, or psychiatric condition that could introduce confounding, e.g., Trisomy 21 or deafness

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Conditions

The condition(s) this trial relates to.

classic galactosemia galactosemia language disorder specific language impairment prevention target speech-sound disorder prevention target

As listed by the trial registrant

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

Classic galactosemia Language disorders in children Speech disorders in children

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.