The goal of this behavioral-interventional study is to learn if the Abecedarian Approach implemented virtually for children ages 0-5 with a history of Hypoxic Ischaemic Encephalopathy (HIE) and/or premature birth produces the same effects as when administered at in-person facilities.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
225
The Abecedarian Approach is an early childhood behavioral education program that aims to improve the learning and cognitive development of children in high-risk or at-risk communities. This study will test the efficacy of implementing this approach in a virtual format.
University of Wisconsin Madison
Madison, Wisconsin, United States
RECRUITINGParent Satisfaction Questionnaire
Questionnaire measuring parent satisfaction with the intervention and effects given at the end of the virtual program. Responses as measured by answering either strongly agree, agree, disagree or strongly disagree. Responses will be measured at the end of the intervention at 60 months and reported as participant counts.
Time frame: Assessed at end of treatment (up to 60 months)
Number of Sessions Attended
We will be taking attendance of sessions to measure parent compliance with the virtual program. Attendance will be taken for each live session (every other week) for the entire period of enrollment (260 weeks).
Time frame: Assessed biweekly from enrollment to end of treatment (up to 260 weeks)
Bayley Assessment
The Bayley is a cognitive and motor assessment conducted by an interventionalist to assess a child's development in these domains. The highest possible score on a subtest or subdomain is 19, and the lowest score is 1. Scores from 8-12 are considered average.
Time frame: Data collected at 12, 24, 36, 48, and 60 month time points
Behavior Reporting Inventory of Executive Function - Preschool Version (BRIEF-P)
Behavior is reported in the BRIEF-P. Behaviors reported by parents can be used to predict later executive function exhibited by children. List of statements provided about child's behavior, parent will answer whether this is never a problem (N), sometimes a problem (S), and often a problem (O). Responses reported as participant counts, answering N more often is considered a better score.
Time frame: Data collected at the 24, 36, 48, and 60 month time points
Pediatric Quality of Life Inventory (PedsQL)
The PedsQL is an inventory of statements scored by reverse-scoring responses to a 5-point Likert scale and then transforming them to a 0-100 scale. A higher score indicates a better quality of life.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Data collected at baseline, 24, 36, 48 and 60 month time points
Early Executive Functions Questionnaire (EEFQ)
A questionnaire is given to parents that assesses what executive functions children are exhibiting. More functions exhibited means further along in executive function development. EEFQ consists of 31 tasks parent is scoring child on, there are 7 options they can choose from regarding how that child performs the task, and in turn are scored 1-7 on the task. Tasks listed as designed to measure cognitive executive function, which should be increasing with age, higher scores are indicative of higher cognitive executive function.
Time frame: Data collected at baseline, 12, and 24 month time points
NIH Baby/Infant and NIH Pediatric Toolbox
A set of tests designed by the NIH administered electronically to children to assess attention, executive function, learning, memory, language, and numeracy/math. A higher early childhood composite score indicates better performance and more of the concept being measured. Early childhood composite score - 100 is the standard, ranges from 70 (extremely low functioning) -130 (extremely high functioning).
Time frame: Data collected at 12, 24, 36, 48, and 60-month time points
Infant Attention Task (IAT) measured in seconds
A behavioral measure used with infants to assess attentional control and processing. Infants are presented with visual puppet stimuli four distinct "looks", and researchers record looking time, shifts in attention, or habituation patterns. More sustained attention in the early looks followed by habituation to the stimuli in the later looks often indicates better early attentional capacity. Total accumulated looking time to a stimulus in visual preference-type tasks commonly ranges from roughly 15-30+ seconds per trial, depending on the infant's age and the stimulus.
Time frame: baseline and 12 months