- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04266717
A Novel Parent Education Program for Early Intervention
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Delaware
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Newark, Delaware, United States, 19713
- University of Delaware
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Baby Play Parent Education Group
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.
|
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.
|
Active Comparator: Milestone Education Group
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alberta Infant Motor Scale - Change in Total Percentile Score
Time Frame: at baseline and 1 month later
|
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.
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at baseline and 1 month later
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michele A Lobo, PT, PhD, University of Delaware
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHYT32228419000
- 2U54GM104941-06 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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