RecruitingNot Applicable

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

United States225 participantsStarted 2025-06-03

Plain-language 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.

Who can participate

Age range5 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. IPNH-NDCP patients, including:
✓. Parent or legal guardian will also be enrolled as a participant
✓. Parents must be English-speaking (able to provide consent and complete questionnaires).

Exclusion criteria

✕. 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.
✕. For parents or legal guardians, there are no exclusion criteria.

What they're measuring

Parent Satisfaction Questionnaire

Timeframe: Assessed at end of treatment (up to 60 months)

Number of Sessions Attended

Timeframe: Assessed biweekly from enrollment to end of treatment (up to 260 weeks)

Trial details

NCT IDNCT06643598

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-03

Contact for this trial

Melisa Carrasco McCaul, MD, PhD

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

View on ClinicalTrials.gov More Hypoxic Ischaemic Encephalopathy (HIE) trials