Abecedarian Approach for Premature Birth

Overseen By Melisa Carrasco McCaul, MD, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Chromosomal abnormalities, Genetic syndromes, Vision impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 260 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Who Is on the Research Team?

Melisa Carrasco McCaul, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for children aged 0-5 who were either diagnosed with hypoxic-ischemic encephalopathy at birth or born prematurely (before 28 weeks). Their parents, who must speak English to give consent and fill out forms, will also take part in the study.

Inclusion Criteria

My parent or guardian is also participating in the trial with me.

My child was either born full-term with brain damage from lack of oxygen or was born prematurely before 28 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Children participate in the Virtual Abecedarian Approach Intervention through a virtual format

260 weeks

Biweekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Abecedarian Approach

Trial Overview The study tests if the Abecedarian Approach, an educational intervention for young children with certain neurological conditions, has similar benefits when done virtually as it does in person.

How Is the Trial Designed?

Group I: Virtual Abecedarian Approach Intervention Experimental Treatment 1 Intervention

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

Group II: Feasibility Group Experimental Treatment 1 Intervention

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

Group III: Standard of Care Provided Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+