Virtual intervention for at-risk children with neurological issues
Healing Tiny Minds: Rural Recovery Through Virtual and Lived Experience Care
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 225 (estimated) |
| Ages | N/A to 5 Years |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT06643598 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with chromosomal abnormalities, genetic syndromes, major congenital malformations, or vision impairments may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Madison, Wisconsin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.