Status:
ACTIVE_NOT_RECRUITING
Preventing Speech and Language Disorders in Children With Classic Galactosemia
Lead Sponsor:
Arizona State University
Collaborating Sponsors:
Washington State University
Conditions:
Classic Galactosemia
Speech Disorders in Children
Eligibility:
All Genders
2-54 years
Phase:
EARLY_PHASE1
Brief Summary
A critical knowledge gap is whether proactive intervention can improve speech and language outcomes in infants at known risk for communication disorders. Speech and language assessments and treatments...
Detailed Description
Speech and language assessments and treatments are usually not initiated until deficits can be diagnosed, which occurs at age 2-3 years at the earliest. Preventive services are not available. Children...
Eligibility Criteria
Inclusion
- 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
- Other forms of galactosemia outside of classic galactosemia
- Medical, sensory, or psychiatric condition that could introduce confounding, e.g., Trisomy 21 or deafness
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2025
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT03838016
Start Date
May 1 2019
End Date
August 31 2025
Last Update
August 28 2025
Active Locations (1)
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1
Arizona State University
Tempe, Arizona, United States, 85287