A Novel Parent Education Program for Early Intervention
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 17, 2018
CompletedFirst Submitted
Initial submission to the registry
October 8, 2019
CompletedFirst Posted
Study publicly available on registry
February 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedResults Posted
Study results publicly available
October 31, 2022
CompletedSeptember 21, 2023
September 1, 2023
2.5 years
October 8, 2019
July 28, 2022
September 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
at baseline and 1 month later
Study Arms (2)
Baby Play Parent Education Group
EXPERIMENTALBaby 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.
Milestone Education Group
ACTIVE COMPARATORParents 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Genetic diagnosis
- Progressive diagnosis such as spinal muscular atrophy
- Medical or movement restrictions that would interfere with participation in the study activities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Delawarelead
- Christiana Care Health Servicescollaborator
- National Institute of General Medical Sciences (NIGMS)collaborator
Study Sites (1)
University of Delaware
Newark, Delaware, 19713, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michele A. Lobo
- Organization
- University of Delaware
Study Officials
- PRINCIPAL INVESTIGATOR
Michele A Lobo, PT, PhD
University of Delaware
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 8, 2019
First Posted
February 12, 2020
Study Start
January 17, 2018
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
September 21, 2023
Results First Posted
October 31, 2022
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share
This small data set will serve as pilot data for future grant applications.