Actively Recruiting
Healing Tiny Minds: Rural Recovery Through Virtual and Lived Experience Care
Led by University of Wisconsin, Madison · Updated on 2026-03-27
225
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether the Abecedarian Approach, an early childhood education program, produces similar effects when delivered virtually compared to in-person settings for children aged 0 to 5 years who have a history of Hypoxic Ischaemic Encephalopathy (HIE) or were born prematurely. This behavioral study aims to learn if the virtual format is accepted by parents and can support cognitive development in at-risk children. Children enrolled in the study will be randomly assigned to one of three groups: a standard care group receiving no intervention, a group receiving the Abecedarian Approach virtually, or a feasibility group with fewer sessions to assess parental acceptance. The intervention focuses on behavioral education delivered through virtual sessions. The study will continue for up to 60 months. Participants and their parents will be involved in attending sessions over the study period, with assessments including parent satisfaction questionnaires and tracking of session attendance. Child development will be monitored using a variety of tools such as the Bayley Assessment, Behavior Reporting Inventory of Executive Function - Preschool Version, Pediatric Quality of Life Inventory, Early Executive Functions Questionnaire, NIH Baby/Infant and Pediatric Toolbox, and Infant Attention Task. Data will be collected at multiple time points up to 60 months to evaluate outcomes.
CONDITIONS
Brief Title
Healing Tiny Minds: Rural Recovery Through Virtual and Lived Experience Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child is a term-born infant diagnosed during the neonatal period with hypoxic-ischemic encephalopathy, or born prematurely before 28 weeks gestational age
- Parent or legal guardian is also enrolled as a participant
- Parents must be English-speaking and able to provide consent and complete questionnaires
You will not qualify if you...
- Not suitable for study participation for reasons decided by the investigator
- Infants with chromosomal abnormalities, genetic syndromes (such as Down Syndrome or Trisomy 18), or major congenital malformations
- Infants with vision impairment
- No exclusion criteria for parents or legal guardians
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Duration - Up to 60 months
Participants take part in the Virtual Abecedarian Approach, an early childhood behavioral education program delivered virtually to support learning and cognitive development.
Biweekly virtual sessions throughout treatment
Duration - Up to 60 months
Participants complete periodic assessments to monitor development and quality of life after treatment.
Assessments at baseline, 12, 24, 36, 48, and 60 months
Trial Site Locations
Total: 1 location
1
University of Wisconsin Madison
Madison, Wisconsin, United States, 53715
Actively Recruiting
Research Team
M
Melisa Carrasco McCaul, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here