This study will test the hypothesis that in preterm infants a caregiver-implemented early developmental intervention (EDI) using finger puppets to develop joint attention and encourage interactive communication with routine EDI care including Bookworm training compared with routine EDI care including Bookworm training alone will increase the Ages and Stages Questionnaire® score at 12 months corrected age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
188
The intervention group will receive finger-puppets and additional training pertaining to infant parent interaction and developmentally appropriate infant communication training.
Routine EDI care including Bookworm training.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGASQ-3 scores
Ages and Stages Questionnaires 3rd Edition
Time frame: 12 months corrected age
ASQ-3 scores
Ages and Stages Questionnaires 3rd Edition
Time frame: 24 months corrected age
ASQ scores below -2SD
Ages and Stages Questionnaires 3rd Edition
Time frame: 12 months corrected age
ASQ scores below -2SD
Ages and Stages Questionnaires 3rd Edition
Time frame: 24 months corrected age
ASQ scores below -1SD
Ages and Stages Questionnaires 3rd Edition
Time frame: 12 months corrected age
ASQ scores below -1SD
Ages and Stages Questionnaires 3rd Edition
Time frame: 24 months corrected age
ASQ-SE2 scores
Ages and Stages Questionnaires 3rd Edition
Time frame: 12 months corrected age
ASQ-SE2 scores
Ages and Stages Questionnaires 3rd Edition
Time frame: 24 months corrected age
Severe neurodevelopmental impairment
Composite outcome based on BSID scores, GMFCS, Vision, Hearing
Time frame: 24 months corrected age
Moderate or severe neurodevelopmental impairment
Composite outcome based on BSID-IV scores, GMFCS, Vision, Hearing
Time frame: 24 months corrected age
Cognitive Composite Score on BSID-IV
Bayley's Scales of Infant Development IV cognitive composite score
Time frame: 24 months corrected age
Language Composite Score on BSID-IV
Bayley's Scales of Infant Development IV language composite score
Time frame: 24 months corrected age
Motor Composite Score on BSID-IV
Bayley's Scales of Infant Development IV motor composite score
Time frame: 24 months corrected age
Edinburgh Postnatal Depression Scale
Maternal scores on Edinburgh Postnatal Depression Scale
Time frame: 6 months
MCHAT score
Modified Checklist for Autism in Toddlers
Time frame: 24 months corrected age
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