Healing Tiny Minds: Rural Recovery Through Virtual and Lived Experience Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 5
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Term-born children diagnosed during the neonatal period with hypoxic-ischemic encephalopathy, or
premature children (born at less than 28 weeks gestational age).
Parent or legal guardian will also be enrolled as a participant
Parents must be English-speaking (able to provide consent and complete questionnaires).
Disqualifiers
Not suitable for study participation due to other reasons at the discretion of the investigator.
Infants with chromosomal abnormalities, genetic syndromes (for example, such as Down Syndrome or Trisomy18) and major congenital malformations will be excluded.
Infants with vision impairment will also be excluded from the study, as our study procedures do require intact vision to be able to complete.
For parents or legal guardians, there are no exclusion criteria.
Trial design
Design model
Single group
Treatments tested in this trial
Abecedarian Approach
BehavioralThe 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.
Treatment groups
225 Participants
are divided into 3 treatment groupsGroup A: Standard of Care ProvidedNo intervention 0 interventions
Group B: Virtual Abecedarian Approach InterventionExperimental treatment 1 intervention
Group C: Feasibility GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Parent 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)2
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)Secondary outcomes
1
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 points2
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 points3
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.
Time frame
Data collected at baseline, 24, 36, 48 and 60 month time points4
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 pointsSponsors and contacts
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Source ClinicalTrials.gov