Clinical trial NCT04266717: A Novel Parent Education Program for Early Intervention
Official title: A Novel Parent Education Program for Early Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infant
Full-term Infant
Keywords: development
infant
preterm
parent education
play
full-term
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: Christiana Care Health Services
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2020-02-12
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: One in 10 children in the United States is born preterm and at risk for disabilities that can impair movement and cognition. Research suggests that targeted early intervention can effectively improve ability and function for these children. However, two key obstacles limit the provision of early intervention services in the first half-year of life. First, the existing diagnostic tools are limited in their ability to identify motor and cognitive delays at early ages. Second, in the medical model there is a lack of understanding of developmental science and how experiences in the first months of life can impact the development of future abilities. In effect, there has been lack of knowledge regarding who should receive early intervention services and what activities should be the focus of those services in infancy.

This project aims to address these challenges by testing the fidelity and short-term efficacy of a novel intervention providing education for parents of preterm infants. The intervention will educate parents on ways to handle, position, and play with their infants to provide infants safe opportunities to explore new ways of moving and controlling their bodies and interacting with objects. Intervention provision will be documented and outcomes will be compared for 20 infants randomized to receive one of two types of developmental education. Pre- and post-assessments will compare motor control in prone, reaching ability, daily positioning practices, and parent-child interactions with toys to determine if there are differences in the short-term effects of the intervention. Intervention will occur for two months with parents logging activity daily. Measures related to dosage and how parents perform the intervention activities will be gathered to assess fidelity of the intervention.

Aim 1: To measure aspects related to fidelity for families participating in the study.

Aim 2: To determine if there is a difference in developmental outcomes for children who receive the intervention.

Eligibility criteria: Inclusion Criteria:

* Infant meeting the age criteria
* Access to the internet
* Residence within driving distance of the University of Delaware
* Parental ability to read and communicate in English

Exclusion Criteria:

* Genetic diagnosis
* Progressive diagnosis such as spinal muscular atrophy
* Medical or movement restrictions that would interfere with participation in the study activities

Primary outcomes:
measure: Alberta Infant Motor Scale - Change in Total Percentile Score
timeFrame: at baseline and 1 month later
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Michele A Lobo, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: