- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05259423
The Effects on Children and Parents of Educating Parents About Ways to Play With Babies
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delaware
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Newark, Delaware, United States, 19713
- University of Delaware
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Typical Development, Enriched Education Program
Parents of infants with typical development (i.e, not meeting the eligibility criteria for early intervention services in the state of Delaware) will receive enriched play activity education based on key ingredients evidenced to advance infant development.
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Enriched play activity education including 9 different activities each with 3 levels depending on the infant's current head and trunk control.
Parents will be instructed to complete 3 activities each day for at least 5 minutes each for a total of 15 minutes per day.
|
Active Comparator: Typical Development, Typical Education Program
Parents of infants with typical development (i.e, not meeting the eligibility criteria for early intervention services in the state of Delaware) will receive typical play education based on usual education found in commonly used websites, apps, and books.
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Typical play activity education including 9 activities commonly described by popular parenting websites, mobile applications, and books.
Parents will be instructed to complete 3 activities each day for at least 5 minutes each for a total of 15 minutes per day.
|
Experimental: Developmental Delay, Enriched Education Program
Parents of infants with/at risk for developmental delay (i.e, meeting the eligibility criteria for early intervention services in the state of Delaware) will receive enriched play activity education based on key ingredients evidenced to advance infant development.
|
Enriched play activity education including 9 different activities each with 3 levels depending on the infant's current head and trunk control.
Parents will be instructed to complete 3 activities each day for at least 5 minutes each for a total of 15 minutes per day.
|
Active Comparator: Developmental Delay, Typical Education Program
Parents of infants with/at risk for developmental delay (i.e, meeting the eligibility criteria for early intervention services in the state of Delaware) will receive typical play education based on usual education found in commonly used websites, apps, and books.
|
Typical play activity education including 9 activities commonly described by popular parenting websites, mobile applications, and books.
Parents will be instructed to complete 3 activities each day for at least 5 minutes each for a total of 15 minutes per day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Infant Motor Development
Time Frame: 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
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Assessed with the Alberta Infant Motor Scale, an observational measure of motor performance in prone, supine, sitting, and standing positions through a total score and sub-scale scores.
Total Score: Minimum: 0; Maximum: 60; Higher score indicating more advanced motor development
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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
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Change in Infant Developmental Outcomes
Time Frame: 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
|
Assessed with the Developmental Assessment of Young Children- 2nd Edition, an assessment of motor, cognitive, and language development through subdomain and standard scores, as well as a general developmental index (normative cumulative score).
Standard scores range from <70 to >130 with higher scores indicating more advanced development.
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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
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Change in Parental Play Behaviors: Positioning
Time Frame: 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
|
A Naturalistic Play Assessment during which we can observe parents' typical daily interaction with infants (i.e., parents are asked to go about their typical activities as if the experimenter were not there) through behavioral coding play sessions lasting 10-20 minutes.
We will video code information related to Positioning: Number of Bouts and percent time in prone, reclined, supine, side-lying, seated, standing, and held.
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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
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Change in Parental Play Behaviors: Handling
Time Frame: 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
|
A Naturalistic Play Assessment during which we can observe parents' typical daily interaction with infants (i.e., parents are asked to go about their typical activities as if the experimenter were not there) through behavioral coding play sessions lasting 10-20 minutes.
We will video code information related to Handling: Number of bouts and percent time with support by a container or parent at the head, upper trunk, lower trunk in prone, reclined, supine, side-lying, seated, standing, held positions.
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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
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Change in Parental Play Behaviors: Communication
Time Frame: 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
|
A Naturalistic Play Assessment during which we can observe parents' typical daily interaction with infants (i.e., parents are asked to go about their typical activities as if the experimenter were not there) through behavioral coding play sessions lasting 10-20 minutes.
We will video code information related to communication: Communication: Number of words (total and number unique), babbling, style (fluctuation in pitch, responsiveness/turn-taking, gestures while communicating, labeling objects).
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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
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Change in Parental Play Behaviors: Toys
Time Frame: 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
|
A Naturalistic Play Assessment during which we can observe parents' typical daily interaction with infants (i.e., parents are asked to go about their typical activities as if the experimenter were not there) through behavioral coding play sessions lasting 10-20 minutes.
We will video code information related to toys: Frequency of toy use, number of unique toys, location of toys (Number of bouts and percent time in reach; Number of bouts and Percent time within-grasp).
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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
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Usability and Feasibility of the Intervention
Time Frame: 1-month from start of study
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The usability and feasibility of both interventions (Enriched Education and Typical Education) will be assessed using a Perception Questionnaire with 7-point Likert Scales (1= Completely Disagree; 7 = Completely Agree) including the meaningfulness and ease of use of the activities.
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1-month from start of study
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Daily Positioning
Time Frame: 2 days surrounding each of the 5 visits: 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
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A position tracking garment, the get-around-garment will be worn during awake times for 2 days to determine the time spent in supine, prone, and upright positions.
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2 days surrounding each of the 5 visits: 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
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Change in Infant Object Exploration
Time Frame: 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
|
Assessed with the Object Exploration Assessment, which measures visual-manual interactions when infants are provided with specific objects (7) with varying properties for 30 seconds each to determine exploration time, bouts of exploration, individual behaviors (i.e., mouthing, looking, touching body, bilateral holding) and multimodal behaviors (i.e., looking while acting).
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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
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Change in Language Development
Time Frame: 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
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The Preschool Language Scales-5th Edition will be given to assess language development including preverbal, interaction-based language skills in the domains of auditory comprehension, and expressive communication standard scores as well as a total language score.
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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
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Change in Parental Beliefs about Development
Time Frame: Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
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Parental beliefs will be measured with the Parental Beliefs on Motor Development scaled score and the Parental Knowledge and Beliefs Questionnaire which was developed to measure parent knowledge and beliefs about motor, cognitive and language development using 7-point Likert Scales.
Items related to each developmental domain (motor, cognitive, language) will be summed to get a domain score in addition to a total score (sum).
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Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
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Change in Parental Knowledge about Development
Time Frame: Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
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Parental knowledge about language and cognitive development will be measured with the Survey of Parent/Provider Expectations and Knowledge and parent knowledge about motor development will be assessed with the Parental Knowledge and Beliefs Questionnaire using 7-point Likert Scales.Items related to each developmental domain (motor, cognitive, language) will be summed to get a domain score in addition to a total score (sum).
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Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
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Change in Parent Beliefs and Knowledge about Play
Time Frame: Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
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The Parent Play Questionnaire will survey parents' beliefs and knowledge about play with infants.
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Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
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Change in Parenting Confidence
Time Frame: Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
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The Karitane Parenting Confidence Scale will assess parents' confidence in their parenting abilities.
Higher scores indicate greater parenting confidence.
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Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
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Change in Parental Practices regarding Motor Development
Time Frame: Baseline (start of study), 3-months from start of study, 6-months from start of study
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The Motor Habits Questionnaire will be used to measure parents' practices regarding motor development.
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Baseline (start of study), 3-months from start of study, 6-months from start of study
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Change in the Time of Achieving Developmental Milestones
Time Frame: Reported at Baseline (start of study) and reported at 1 month- intervals through the onset of independent walking (Typically 12 -15 months) or when the child reaches 24 months of age (whichever occurs first)
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The Parental Milestone Report will be used to track the timing of the development of key developmental milestones through the onset of independent walking.
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Reported at Baseline (start of study) and reported at 1 month- intervals through the onset of independent walking (Typically 12 -15 months) or when the child reaches 24 months of age (whichever occurs first)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Affordances in the Home Environment Impact Child Developmental Outcomes and Parental Characteristics
Time Frame: Baseline (start of study)
|
The Affordances in the Home Environment for Motor Development-Infant Scale will be used to survey the toys, space, and surfaces available in the home environment.
Potential relationships between affordances in the home environment and child developmental outcomes and parental characteristics will be explored.
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Baseline (start of study)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michele A Lobo, PT, PhD, University of Delaware
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Other Study ID Numbers
- 1858581-1
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
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