Virtual intervention for at-risk children with neurological issues
Official title: Healing Tiny Minds: Rural Recovery Through Virtual and Lived Experience Care
Run by University of Wisconsin, Madison · NCT06643598 · Data updated 2026-11-12
This study is testing if a virtual program can help young children with neurological issues, like those born prematurely, just as well as in-person help does.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 5 Years |
| Sex | All |
| Enrollment | 225 (estimated) |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Status | Recruiting |
| Started | June 3, 2025 |
| Main results expected | March 2030 |
| Study ends | March 2030 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT06643598 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include children aged 0-5 with a diagnosis of HIE or those born prematurely at less than 28 weeks gestational age.
✕Probably not a fit
Patients with chromosomal abnormalities, genetic syndromes, major congenital malformations, or vision impairments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This behavioral-interventional study aims to evaluate the effectiveness of the Abecedarian Approach delivered virtually to children aged 0-5 who have a history of Hypoxic Ischaemic Encephalopathy (HIE) or premature birth. The study seeks to determine if virtual implementation can achieve similar outcomes as in-person interventions. Parents or legal guardians will also participate, providing consent and completing questionnaires to assess the intervention's impact.
Why it matters
Potential benefit: If successful, this approach could provide accessible early intervention for at-risk children, potentially improving their developmental outcomes.
How similar studies have gone: While the virtual implementation of the Abecedarian Approach is a novel approach, similar interventions have shown promise in improving developmental outcomes in at-risk populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
University of Wisconsin Madison
Madison, Wisconsin, United States Recruiting
Study contacts
- Principal investigator: Melisa Carrasco McCaul, MD, PhD — University of Wisconsin, Madison
- Study coordinator: Melisa Carrasco McCaul, MD, PhD
- Email: carrascomccaul@neurology.wisc.edu
- Phone: 608-577-2415
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.