Preventing Speech and Language Disorders in Children With Classic Galactosemia
Classic Galactosemia, Speech Disorders in Children, Language Disorders in Children
About this trial
This is an interventional treatment trial for Classic Galactosemia
Eligibility Criteria
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
Sites / Locations
- Arizona State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
No Intervention
No Intervention
Treatment cohort with classic galactosemia
Treatment cohort with classic galactosemia, delayed start
Older control cohort with classic galactosemia
Typical controls
These children and their parents receive the Babble Boot Camp intervention and also participate in the close monitoring activities (progress reports that the speech-language pathologist generates during the online meeting with the family; monthly daylong audio recording; questionnaires that are sent out every three to six months; formal speech and language testing at ages 2 1/2, 3 1/2, and 4 1/2 years).
The children in the control cohort enter the study when they are younger than 5 months old and participate in the close monitoring until they are 24 months old. They start getting the same treatment type and intensity as the treatment cohort but at a delayed age, when they turn 15 months.
The children in the older control cohort are 6 months to 4 1/2 years old and provide standardized test results in the area of speech and language development at child ages 2 1/2, 3 1/2, and 4 1/2 years. They receive no treatment and no close monitoring. These families provide questionnaire information every three months until child age 24 months.
These children are free of any medical or developmental diagnosis. They enter the study at ages 2 to 5 months and provide close monitoring data until they are 24 months old, then they receive standardized speech and language testing at ages 2 1/2, 3 1/2, and 4 1/2 years, just like the treatment cohort, but the typical controls receive no treatment under this study.