CompletedNot Applicable

The Effects on Children and Parents of Educating Parents About Ways to Play With Babies

United States49 participantsStarted 2022-04-01

Plain-language summary

The purpose of this study is to determine whether educating parents about how to play with infants affects infant development or caregiver characteristics. The project will comparatively evaluate the effects of two different play education programs on infants' development and on caregiver characteristics in a sample of infants with typical development and a sample of infants with/at risk for developmental delay.

Who can participate

Age range1 Month – 24 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Able to engage in the data collection activities and be available for either in-person or virtual visits * Parent participating in the study must be at least 18 years of age * Parent must be able to speak and read in English * Parent must be physically capable of performing the play activities with their infant (i.e., able to carry the infant and play on the floor with the infant). * If parents choose to participate virtually, they must report having a device with a camera and microphone for the use of Zoom and access to the internet. * Infants must be between the ages of 1 month and 6 months at enrollment * Infants must not be legally blind * Infants who meet the criteria for the State of Delaware Early Intervention Inclusion Criteria will be included in the at-risk group. These criteria are: 1) established conditions, such as chromosomal disorders, genetic disorders, and neurologic disorders; or 2) developmental delay measured via a standardized developmental assessment (e.g., the DAY-C). Exclusion Criteria: * None beyond inclusion criteria

What they're measuring

Change in Infant Motor Development

Timeframe: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study

Change in Infant Developmental Outcomes

Timeframe: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study

Change in Parental Play Behaviors: Positioning

Timeframe: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study

Change in Parental Play Behaviors: Handling

Timeframe: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study

Change in Parental Play Behaviors: Communication

Timeframe: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study

Change in Parental Play Behaviors: Toys

Timeframe: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study

Trial details

NCT IDNCT05259423

SponsorUniversity of Delaware

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-01

View on ClinicalTrials.gov More Infant Development trials

Plain-language summary

Who can participate

Age range1 Month – 24 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Infant Motor Development

Timeframe: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study

Change in Infant Developmental Outcomes

Timeframe: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study

Change in Parental Play Behaviors: Positioning

Timeframe: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study

Change in Parental Play Behaviors: Handling

Timeframe: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study

Change in Parental Play Behaviors: Communication

Timeframe: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study

Change in Parental Play Behaviors: Toys

Timeframe: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study