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A Novel Parent Education Program for Early Intervention

Primary Purpose

Preterm Infant, Full-term Infant

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Baby Play Intervention
Milestone Education
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Infant focused on measuring development, infant, preterm, parent education, play, full-term

Eligibility Criteria

1 Month - 1 Year (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Delaware

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Baby Play Parent Education Group

Milestone Education Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Alberta Infant Motor Scale - Change in Total Percentile Score
We will assess infants using the AIMS, a valid and reliable developmental assessment for 0-18-month-olds. It consists of observation of weight bearing, posture, and antigravity movement in supine, prone, sitting, and standing subscales. Infants will receive scores for each subscale (secondary outcomes) that are summer for a total sum score that will be converted to percentile rank (ranging from 0-100). The change in percentile rank from baseline through 1 month will serve as the primary outcome measure for this study to compare the effects of the two interventions with a higher value representing a greater change and the sign representing the direction of change (i.e., positive means developmental performance improved). The AIMS will be used because the PI has shown it to be a sensitive measure of change for FT infants whose parents received handling and positioning education.

Secondary Outcome Measures

Full Information

First Posted
October 8, 2019
Last Updated
September 1, 2023
Sponsor
University of Delaware
Collaborators
Christiana Care Health Services, National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT04266717
Brief Title
A Novel Parent Education Program for Early Intervention
Official Title
A Novel Parent Education Program for Early Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 17, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware
Collaborators
Christiana Care Health Services, National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant, Full-term Infant
Keywords
development, infant, preterm, parent education, play, full-term

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baby Play Parent Education Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Milestone Education Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Baby Play Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Milestone Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Alberta Infant Motor Scale - Change in Total Percentile Score
Description
We will assess infants using the AIMS, a valid and reliable developmental assessment for 0-18-month-olds. It consists of observation of weight bearing, posture, and antigravity movement in supine, prone, sitting, and standing subscales. Infants will receive scores for each subscale (secondary outcomes) that are summer for a total sum score that will be converted to percentile rank (ranging from 0-100). The change in percentile rank from baseline through 1 month will serve as the primary outcome measure for this study to compare the effects of the two interventions with a higher value representing a greater change and the sign representing the direction of change (i.e., positive means developmental performance improved). The AIMS will be used because the PI has shown it to be a sensitive measure of change for FT infants whose parents received handling and positioning education.
Time Frame
at baseline and 1 month later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele A Lobo, PT, PhD
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This small data set will serve as pilot data for future grant applications.

Learn more about this trial

A Novel Parent Education Program for Early Intervention

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