A Novel Parent Education Program for Early Intervention

NCT04266717 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-09-21

Study results available
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Summary

One in ten infants born in the USA is born preterm before 37 weeks of gestation and 50% of those will have motor and cognitive delays requiring intervention at school age. Because existing assessments do not reliably identify motor and cognitive delays early in development, many infants born preterm do not receive early intervention until they are older and their delays are more pronounced. This project aims to address the need for an effective, affordable, novel early intervention model for the first months of life for preterm infants.

Conditions

  • Preterm Infant
  • Full-term Infant

Interventions

BEHAVIORAL

Baby Play Intervention

Baby Play Intervention involves teaching parents targeted ways they can handle, position, and play with young infants that aim to provide infants enhanced early opportunities to learn to control their bodies and interact with objects. These abilities are associated with future motor, cognitive, and language outcomes. Parents will be asked to perform the intervention activities 20 minutes daily and to log their activity performance weekly.

BEHAVIORAL

Milestone Education

Parents in the Milestone Education Intervention group will receive information regarding milestones expected based on infants' CA. This information is based on forms from the Centers for Disease Control and Prevention (CDC) and The American Academy of Pediatrics (AAP). This will help parents understand the milestones typically observed at the their child's CA and reflects the education parents receive from healthcare providers. Parents will be asked to provide their infants opportunities to perform these milestone behaviors 20 minutes daily and to log their activity performance weekly.

Sponsors & Collaborators

  • Christiana Care Health Services

    collaborator OTHER
  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH
  • University of Delaware

    lead OTHER

Principal Investigators

  • Michele A Lobo, PT, PhD · University of Delaware

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
1 Year
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-17
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04266717 on ClinicalTrials.gov