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

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT06643598
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - 5 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 3, 2025
Status verified
Mar 2026
Primary completion
Mar 31, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
225 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.
  • Experimental: Feasibility Group
    Participants will be in fewer sessions in order to assess whether the intervention is accepted by the parents.

Primary Outcome Measure

Parent Satisfaction Questionnaire [ Time Frame: Assessed at end of treatment (up to 60 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin MadisonMadisonWisconsin53715
Melisa Carrasco McCaul, MD, PhD
608-577-2415

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By research site
University of Wisconsin Madison· Madison, WI

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