Supporting Infant Development Through Tummy Time, Positioning, and Limiting Baby Gear
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-4
SponsorUniversity of Tennessee
About this trial
The goal of this clinical trial is to examine the impact of an educational intervention on infant motor skill development. The main question it aims to answer is: Question 1) Does exposure to an educational intervention on infant development positively impact infant motor skill development? Researchers will compare the intervention group to the treatment as usual group see if there are differences in infant motor skill development.
The purpose of the proposed study is to determine if tummy time, play positions, screen time, and use of baby gear impacts early motor skill development in children. This is a Pilot study. A Pilot study is a small study that is carried out to collect information that will help in the planning of a larger study with the same topic.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Parent of the infant speaks and reads English
Individual is the parent or legal guardian of the infant.
Infant is 1 month of age or younger
Infant was carried to at least 37-weeks' gestation
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Parent Informational Session
BehavioralParents will receive a brochure on the importance of tummy time and limiting baby gear and watch a video on the importance of tummy time and limiting baby gear and receive support for implementing tummy time if requested.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Usual Care Group Receiving an Informational Tummy Time BrochureNo intervention 0 interventions
Group B: Parent Informational SessionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in motor scale score on the Bailey Scales of Infant & Toddler Development
Scores range from 40 to 160, with higher scores indicating more advanced development
Time frame
6 months to 48 months of ageSecondary outcomes
1
Change in fine motor scale score on the Ages & Stages Questionnaire-3
Scores range from 0 to 60 with higher scores indicating more advanced motor development
Time frame
6 months to 48 months of ageSponsors and contacts
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Source ClinicalTrials.gov