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NCT06450509 · ClinicalTrials.gov registry record · NA
Proactive Speech and Language Intervention for Infants With Down Syndrome
A NA study of Down Syndrome, sponsored by Arizona State University.
- Active
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06450509: Active NA study of Down Syndrome, sponsored by Arizona State University.
NCT06450509 is a NA study of Down Syndrome that is active but no longer recruiting, run by Arizona State University. The registered enrollment target is 60 participants, below the 2,471-participant average among 54 other Down Syndrome trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06450509, a NA study of Down Syndrome, is active but no longer recruiting, sponsored by Arizona State University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Children with Down syndrome (DS) face life-long struggles with verbal communication. Babble and speech sound development is delayed, and speech can be difficult to understand. Words emerge late, at 21 months on average, compared to 12 months for typical peers, and vocabulary and grammar can remain limited throughout adulthood. Because DS is diagnosed at or even before birth, these difficulties are predictable; yet despite this prognostic knowledge, systematic and sustained proactive interventions have not yet been developed: Most children with DS are not assessed and treated for speech and language delays until age 2 to 4 years. This presents an untapped opportunity space to conduct a clinical trial of a proactive intervention in earliest infancy with the goal of building resilience against the anticipated difficulties. The intervention trialed here is a modified version of Babble Boot Camp (BBC), a proactive speech and language intervention originally developed for young infants with classic galactosemia (CG) (NIH 5R01HD098253). CG is a metabolic disease that, similar to DS, is diagnosed at birth and poses risks for severe speech and language delays. BBC is implemented by a speech-language pathologist who, via telehealth, trains parents to incorporate skill-building activities and routines into their daily lives at home. For the present study, 20 children with DS age birth to 12 months will be recruited and randomized into two treatment arms. One group will receive weekly individualized parent sessions and close monitoring of the child's progress. The second group will receive the same content but at a lower intensity and dosage, via monthly parent group meetings. Both groups will receive their intervention for 10 months. Specific aims are to quantify benefits for babble, speech production, and receptive and expressive language and to investigate associations between conversational dynamics in child-adult interactions and the children's speech and language. Outcome
Primary Outcome
Families will provide a set of three day-long audio recordings. Using the day-long audio recordings, the investigators will obtain adult word counts, child utterance counts, and conversational turn rates.
Conditions Studied
Interventions
- BEHAVIORAL Babble Boot Camp
Study Locations (1)
Arizona
- Arizona State University - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-02-28 |
| Est. Completion | 2026-03-30 |
| Phase | NA |
What the registry record for NCT06450509 still lists
NCT06450509 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 2,471-participant average among 54 other Down Syndrome trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Down Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Babble Boot Camp is the first listed.
NCT06450509 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT06450509 about?
NCT06450509 is a clinical study titled "Proactive Speech and Language Intervention for Infants With Down Syndrome". Children with Down syndrome (DS) face life-long struggles with verbal communication. Babble and speech sound development is delayed, and speech can be difficult to understand. Words emerge late, at 21 months on average, compared to 12 months for typical peers, and vocabulary and grammar can remain l...
What is the current status of trial NCT06450509?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2024-02-28. Estimated completion is 2026-03-30.
What conditions does trial NCT06450509 study?
This clinical trial studies the following conditions: Down Syndrome.
What interventions are being tested in trial NCT06450509?
The interventions under investigation include: Babble Boot Camp (BEHAVIORAL).
Who is sponsoring clinical trial NCT06450509?
This trial is sponsored by Arizona State University, which has 187 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06450509 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06450509's enrollment target sits among peer trials
60 30th of 54 higher than 23 of 54 other Down Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Down Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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