Healing Tiny Minds: Rural Recovery Through Virtual and Lived Experience Care

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 Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Premature Birth; Neurological Disorder; Hypoxic Ischaemic Encephalopathy (HIE)
• Intervention / Treatment: Behavioral: Abecedarian Approach

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melisa Carrasco McCaul, MD, PhD; Phone Number: 608-577-2415; Email: carrascomccaul@neurology.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Recruiting
      • University of Wisconsin Madison
      • Contact: Melisa Carrasco McCaul, MD, PhD; Phone Number: 608-577-2415

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. IPNH-NDCP patients, including:

   • Term-born children diagnosed during the neonatal period with hypoxic-ischemic encephalopathy, or
   • premature children (born at less than 28 weeks gestational age).
2. Parent or legal guardian will also be enrolled as a participant
3. Parents must be English-speaking (able to provide consent and complete questionnaires).

Exclusion Criteria:

1. Not suitable for study participation due to other reasons at the discretion of the investigator.
2. Infants with chromosomal abnormalities, genetic syndromes (for example, such as Down Syndrome or Trisomy18) and major congenital malformations will be excluded.
3. Infants with vision impairment will also be excluded from the study, as our study procedures do require intact vision to be able to complete.
4. For parents or legal guardians, there are no exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care Provided; In the No Intervention condition, at-risk children will receive the current standard of care, and no intervention.
Experimental: Virtual Abecedarian Approach Intervention; In the Virtual Abecedarian Approach Intervention, children will partake in the Abecedarian Approach Intervention through a virtual format.	Behavioral: Abecedarian Approach; 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.
Experimental: Feasibility Group; Participants will be in fewer sessions in order to assess whether the intervention is accepted by the parents.	Behavioral: Abecedarian Approach; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	Assessed biweekly from enrollment to end of treatment (up to 260 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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).	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.	baseline and 12 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Melisa Carrasco McCaul, MD, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Brain Ischemia; Signs and Symptoms, Respiratory; Brain Damage, Chronic; Hypoxia, Brain; Hypoxia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Premature Birth; Cerebral Palsy; Nervous System Diseases; Hypoxia-Ischemia, Brain
• Other Study ID Numbers: 2024-1658; A535100 (Other Identifier: UW Madison); Protocol Version 3/11/2026 (Other Identifier: UW Madison)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No