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?

This trial aims to determine if the Abecedarian Approach, a method for supporting early childhood development, is as effective online as in person. The trial includes children aged 0-5 who were either born prematurely (before 28 weeks) or had hypoxic-ischemic encephalopathy, a type of newborn brain injury. Participants will receive standard care, join virtual sessions, or be part of a group with fewer sessions to assess parental usefulness. Families where parents or guardians speak English and can complete surveys are well-suited for this study. As an unphased trial, this study allows families to contribute to innovative research that could enhance support for early childhood development.

Will I have to stop taking my current medications?

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

What prior data suggests that the Abecedarian Approach is safe for children with a history of HIE and/or premature birth?

Past studies have shown the Abecedarian Approach to be safe and well-tolerated. This method, which focuses on early education, has been used in settings like group child care and home visits without any known serious side effects. It has been researched for many years, emphasizing positive interactions between adults and children for developmental benefits.

For the online version of the Abecedarian Approach and the feasibility group, no specific data on negative effects have been reported. The method's long history in various settings suggests it is generally safe. Both groups in this trial are testing a version of the Abecedarian Approach, so safety is expected to align with past versions. Overall, participants in these programs have not typically experienced harmful effects, indicating they are well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Abecedarian Approach for premature birth because it introduces a new way of supporting early childhood development through a virtual format. Unlike traditional care options that focus on medical interventions and therapies, this approach emphasizes cognitive and social stimulation, which can be conveniently delivered online. The virtual aspect of the Abecedarian Approach makes it accessible to families regardless of their location, potentially offering a more inclusive and flexible option for parents. Additionally, the feasibility group aims to understand how well parents accept this intervention, which could lead to more tailored and effective support for at-risk children.

What evidence suggests that the Abecedarian Approach might be an effective treatment for premature birth?

Research has shown that the Abecedarian Approach positively affects children, especially those born early or with low birth weight. Studies have found that this educational method can improve IQ scores and mental development, with benefits lasting into young adulthood. Children who began the Abecedarian program early had higher IQ scores than those who did not participate. The approach also improves overall life outcomes, such as health and job opportunities, as the children grow up. In this trial, some participants will receive the Virtual Abecedarian Approach Intervention, which aims to bring these benefits directly into homes. ^{6 7 8 9 10}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3989926/

Adult Outcomes as a Function of an Early Childhood ... The Abecedarian Project was a prospective randomized trial designed to learn the extent to which intensive early childhood education could ...

2. cehd.uchicago.edu cehd.uchicago.edu/?page_id=517

Cost/Benefit Analysis Project Rich data on the individuals are collected through age 35. We calculate the effect of Abecedarian/CARE on life-cycle outcomes including health, employment, ...

3. evidencebasedprograms.org evidencebasedprograms.org/document/abecedarian-project-evidence-summary/

Evidence Summary for the Abecedarian Project Were 1.8 years older when their first child was born (an average of 21.8 years of age for the. Abecedarian group vs. 20.0 years of age for the control group).

4. abc.fpg.unc.edu abc.fpg.unc.edu/follow-up-studies/

Follow-Up Studies - The Carolina Abecedarian Project Through age 15, I.Q. scores for the children who received the birth-to-age-5 Abecedarian intervention were higher than those of the randomly assigned control ...

5. nieer.org nieer.org/sites/default/files/2023-07/BenefitCostAbecedarian.pdf

Comparative benefit–cost analysis of the Abecedarian ... We present a benefit–cost analysis of a preschool program that provided intensive education during full-day child care. Data were obtained from a randomized ...

6. withpower.com withpower.com/trial/phase-nervous-system-diseases-2025-426a3?condition=cerebral+palsy&overallStatus=Recruiting&hasNoPlacebo=false

Abecedarian Approach for Premature Birth This N/A medical study run by University of Wisconsin, Madison is evaluating whether Abecedarian Approach will have tolerable side effects & efficacy for ...

7. journals.openedition.org journals.openedition.org/factsreports/877

Feasibility of Implementing an Early Intervention Program ... An early intervention program (EIP) could improve neuro-developmental outcomes in survivors of birth asphyxia, but its feasibility in low-income countries has ...

8. cdacouncil.org cdacouncil.org/en/newsletter/dr-joseph-sparling-looks-back-on-a-life-devoted-to-enriching-early-care-and-education/

Dr. Joseph Sparling Looks Back on a Life Devoted to ... In the Abecedarian Project, the researchers recruited 111 young babies from impoverished moms, many of them single parents with a history of ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8297297/

Mental Health and Social Development Effects of the ... The Abecedarian Approach is distinctive in its design and research and in its persistent and pervasive focus on adult-child interaction. It is ...

10. researchgate.net researchgate.net/publication/334948201_The_Abecedarian_Approach_in_a_Low-Resource_Urban_Neighborhood_in_Canada_An_Impact_Evaluation_in_a_Child_Care_Setting

(PDF) The Abecedarian Approach in a Low-Resource ... This evaluation explores the impact of the Abecedarian Approach for early education on the language development of First Nations and non-First ...