Recruiting

Abecedarian Approach

Sponsor:

University of Wisconsin, Madison

Code:

NCT06643598

Conditions

Hypoxic Ischaemic Encephalopathy (HIE)

Premature Birth

Cerebral Palsy

Neurological Disorder

Eligibility Criteria

Sex: All

Age: 0 - 5

Healthy Volunteers: Not accepted

Interventions

Abecedarian Approach

Study Details

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

Study ID

NCT06643598

Start date

Jun 3, 2025

Status verified date

Mar, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 5

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

225 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Abecedarian Approach

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.

Primary outcome measure

  • Parent Satisfaction Questionnaire [ Time Frame: Assessed at end of treatment (up to 60 months) ]
  • Number of Sessions Attended [ Time Frame: Assessed biweekly from enrollment to end of treatment (up to 260 weeks) ]

Central Contacts and Locations

Central contacts

Melisa Carrasco McCaul, MD, PhD

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

Locations

University of Wisconsin Madison

Recruiting

Madison, Wisconsin, United States, 53715

Contacts

Melisa Carrasco McCaul, MD, PhD

608-577-2415

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-03-27.