A Phase 2 interventional study of AAC Generative Language Intervention and Standard of Care / Business as Usual in Down Syndrome, Speech and Language Disorder and Speech Disorders in Children, sponsored by University of Central Florida. Completed at 2 sites in United States. Open to participants aged 3 Years to 4 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-08.
Sponsored by University of Central Florida · Phase 2, Interventional, and Treatment
The focus of this investigation is to compare the effectiveness of the AAC Generative Language Intervention approach to an AAC Standard of Care condition on preschool sentence productions. All children will use existing AAC iPad applications.
The central hypothesis is that preschoolers receiving AAC Generative Language Intervention will create longer, more grammatically complete sentences compared with the Standard of Care condition. Specific Aim 1 compares these interventions for preschoolers with severe speech impairments and typical receptive language, and Specific Aim 2 does the same for children with Down syndrome. Specific Aim 3 tests for possible moderation of the intervention effect by age, dynamic assessment scores, sentence type, receptive language abilities, prior AAC use, sex, mental age, and disability. Aims 1 and 2 will be accomplished using randomized controlled trials.
438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.
This study's enrollment of 70 is above the median of 37 across 286 interventional studies indexed under Down Syndrome.
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Exclusion Criteria:
AAC Generative Language Intervention
Behavioral: AAC Generative Language Intervention · Behavioral: Standard of Care / Business as Usual
Standard of Care / Business as Usual
Behavioral: Standard of Care / Business as Usual
Parent/Caregiver AAC App Operational Training + Direct AAC Input-Output Language Intervention
Parent/Caregiver AAC App Operational Training
Aided AAC Utterance Length
Aided AAC sentence length measured in morphemes
Time frame: 6 Months
Plan to share: No
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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