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

NCT06643598 | Recruiting

• 3 other identifiers: 2024-1658Protocol Version 3/11/2026A535100
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoxic Ischaemic Encephalopathy (HIE); Premature Birth; Cerebral Palsy; Neurological Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Bayley Assessment

  Data collected at 12, 24, 36, 48, and 60 month time points

• Behavior Reporting Inventory of Executive Function - Preschool Version (BRIEF-P)

  Data collected at the 24, 36, 48, and 60 month time points

• Pediatric Quality of Life Inventory (PedsQL)

  Data collected at baseline, 24, 36, 48 and 60 month time points

• Early Executive Functions Questionnaire (EEFQ)

  Data collected at baseline, 12, and 24 month time points

• NIH Baby/Infant and NIH Pediatric Toolbox

  Data collected at 12, 24, 36, 48, and 60-month time points

Study Arms (3)

Standard of Care Provided

NO INTERVENTION

In the No Intervention condition, at-risk children will receive the current standard of care, and no intervention.

Virtual Abecedarian Approach Intervention

EXPERIMENTAL

In the Virtual Abecedarian Approach Intervention, children will partake in the Abecedarian Approach Intervention through a virtual format.

Behavioral: Abecedarian Approach

Feasibility Group

EXPERIMENTAL

Participants will be in fewer sessions in order to assess whether the intervention is accepted by the parents.

Behavioral: Abecedarian Approach

Interventions

Abecedarian Approach BEHAVIORAL

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.

Feasibility Group; Virtual Abecedarian Approach Intervention

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).
• Parent or legal guardian will also be enrolled as a participant
• Parents must be English-speaking (able to provide consent and complete questionnaires).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Madison

Madison, Wisconsin, 53715, United States

RECRUITING

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Premature Birth; Cerebral Palsy; Nervous System Diseases

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Damage, Chronic

Study Officials

• Melisa Carrasco McCaul, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melisa Carrasco McCaul, MD, PhD

CONTACT

608-577-2415; carrascomccaul@neurology.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 16, 2024
• Study Start: June 3, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)