Early Literacy Program for Preterm Infants

(BUILD Trial)

Overseen By Colm Travers

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Major malformation, Known syndrome, others

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

Compensation: Varies

Number of Visits: 3

Duration: 24 months

188 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Coach-led caregiver-implemented early literacy and developmental programming for preterm infants?

Research shows that early literacy and language programs for parents of preterm infants, such as those in the NICU, can improve language development and parent-infant interactions. These programs help parents feel more confident in engaging with their infants, which can lead to better language and cognitive outcomes for the children. ^{1 2 3 4 5}

Is the Early Literacy Program for Preterm Infants safe for humans?

Preliminary evidence suggests that shared reading interventions in the NICU are safe and well accepted by parents, with potential positive effects on preterm infants' physiological parameters and cognitive development. ^{1 2 3 4 6}

How is the Coach-led caregiver-implemented early literacy and developmental programming treatment different from other treatments for preterm infants?

This treatment is unique because it involves caregivers actively participating in early literacy and developmental activities with guidance from a coach, focusing on enhancing the language environment and reducing parental stress, which is not typically emphasized in standard medical treatments for preterm infants. ^{1 2 3 6 7}

What is the purpose of this trial?

The purpose of this study is to see if an early literacy and developmental program in addition to shared reading can increase developmental test scores at 24 months of age. All caregivers of infants in this study will receive shared reading training. Half of the caregivers will be trained in an additional coach-led caregiver-implemented early literacy and numeracy program. Information related to infant development will be collected from parent surveys, medical records, and questionnaires and assessments.

Research Team

Colm P Travers, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for caregivers of preterm infants and neonates. It aims to include those who are willing to participate in early literacy and developmental programs, with the goal of improving their child's development by age 24 months.

Inclusion Criteria

Inborn at UAB

Delivered at more than 35 weeks' gestation

I am expected to go home after my first hospital stay.

Exclusion Criteria

Presence of a known syndrome

Enrolled in a competing study

My family primarily speaks a language other than English or Spanish.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Caregivers receive shared reading training, with half receiving additional coach-led early literacy and developmental program

24 months

Regular well-child visits

Follow-up

Participants are monitored for developmental progress and literacy scores

36 months

ASQ-3 assessments at 12, 24, and 36 months; literacy assessments at 3, 4, and 5 years

Long-term follow-up

Assessment of kindergarten readiness and literacy scores at 60 months

60 months

Treatment Details

Interventions

• Coach-led caregiver-implemented early literacy and developmental programming

Trial Overview The study tests if adding a coach-led caregiver-implemented program to shared reading training can boost developmental scores at two years old. Caregivers will either receive just reading training or both reading and the additional program.

Participant Groups

Group I: Reach Out and Read plus intervention Experimental Treatment 2 Interventions

Reach Out and Read Training in addition to coach-led caregiver-implemented early literacy and developmental program

Group II: Reach out and Read only Active Control 1 Intervention

Reach Out and Read at well child visits

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

A study involving 284 very preterm infants assessed the effectiveness of a home-based developmental education intervention, but by age 5, there were no significant differences in cognitive, behavioral, or motor outcomes among the intervention groups compared to standard care.

Despite some initial advantages observed at 2 years, the benefits of early intervention did not persist by age 5, raising questions about the long-term efficacy of such programs for improving outcomes in very preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised trial of parental support for families with very preterm children: outcome at 5 years. Johnson, S., Ring, W., Anderson, P., et al.[2019]

A randomized controlled trial involving 95 preterm infants showed that a parent-driven language intervention in the neonatal intensive care unit significantly increased adult word counts and improved language scores at 2 years of age.

The intervention led to an 80% reduction in the odds of having a low language composite score and a 90% reduction in the odds of low receptive language scores, indicating its effectiveness in enhancing language development for preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a Neonatal Intensive Care Unit Language Intervention for Parents of Preterm Infants and 2-Year Language Outcomes. McGowan, EC., Caskey, M., Tucker, R., et al.[2023]

Shared book-reading interventions in neonatal intensive care units (NICUs) are feasible and well-accepted, providing support for parents and potentially improving language development in preterm infants.

Preliminary evidence suggests that these interventions may lead to better cognitive outcomes, as one study indicated a lower decline in language development for preterm infants who participated in shared reading compared to a historical control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A narrative review of the effect of parent-child shared reading in preterm infants. Boissel, L., Guilé, JM., Viaux-Savelon, S., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Randomised trial of parental support for families with very preterm children: outcome at 5 years. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a Neonatal Intensive Care Unit Language Intervention for Parents of Preterm Infants and 2-Year Language Outcomes. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of an Early Language and Literacy Program for Parents of Infants in the NICU. [2020]

4. Norway pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of maternal infant-directed reading among hospitalised preterm infants. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Parent picture-book reading to infants in the neonatal intensive care unit as an intervention supporting parent-infant interaction and later book reading. [2015]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A narrative review of the effect of parent-child shared reading in preterm infants. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Parental interventions and the development of the preterm infant. [2019]