Virtual A2 Study for At Risk Children

University of Wisconsin (UW)

Status: Enrolling

Conditions: Neurological Disorder; Cerebral Palsy; Hypoxic Ischaemic Encephalopathy (HIE); Premature Birth

Treatments: Behavioral: Abecedarian Approach

Study type: Interventional

Funder types: Other

Identifiers

NCT06643598

A535100 (Other Identifier)

Protocol Version 6/26/2025 (Other Identifier)

2024-1658

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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100 participants in 3 patient groups

Standard of Care Provided

No Intervention group

Description:

In the No Intervention condition, at-risk children will receive the current standard of care, and no intervention.

Virtual Abecedarian Approach Intervention

Experimental group

Description:

In the Virtual Abecedarian Approach Intervention, children will partake in the Abecedarian Approach Intervention through a virtual format.

Treatment:

Behavioral: Abecedarian Approach

Feasibility Group

Experimental group

Description:

Participants will be in fewer sessions in order to assess whether the intervention is accepted by the parents.

Treatment:

Behavioral: Abecedarian Approach