The Effects on Children and Parents of Educating Parents About Ways to Play With Babies
1 other identifier
interventional
49
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2022
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
First Submitted
Initial submission to the registry
February 3, 2022
CompletedFirst Posted
Study publicly available on registry
February 28, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2023
CompletedMay 16, 2024
May 1, 2024
1.1 years
February 3, 2022
May 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Change in Infant Motor Development
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
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
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.
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
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.
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
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.
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
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).
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
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).
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
Usability and Feasibility of the Intervention
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.
1-month from start of study
Secondary Outcomes (9)
Change in Daily Positioning
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
Change in Infant Object Exploration
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 Language Development
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 Beliefs about Development
Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
Change in Parental Knowledge about Development
Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
- +4 more secondary outcomes
Other Outcomes (1)
Affordances in the Home Environment Impact Child Developmental Outcomes and Parental Characteristics
Baseline (start of study)
Study Arms (4)
Typical Development, Enriched Education Program
EXPERIMENTALParents 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.
Typical Development, Typical Education Program
ACTIVE COMPARATORParents 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.
Developmental Delay, Enriched Education Program
EXPERIMENTALParents 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.
Developmental Delay, Typical Education Program
ACTIVE COMPARATORParents 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Delaware
Newark, Delaware, 19713, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michele A Lobo, PT, PhD
University of Delaware
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants will not be aware of their group assignment as all families will receive education about nine play activities. Sealed envelopes created prior to enrollment will conceal assignments (i.e., appropriate educational materials) and the next envelope for the correct block \[Block 1: typical development (TD), low SES; Block 2: TD, mid-high SES; Block 3 developmental delay (DD), low SES; Block 4: DD, mid-high SES\] will be handed to families by the blind assessor at in-person visits or emailed to virtual participants by a team member not engaged in the blind assessments.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 3, 2022
First Posted
February 28, 2022
Study Start
April 1, 2022
Primary Completion
May 1, 2023
Study Completion
November 10, 2023
Last Updated
May 16, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
A data sharing agreement is in place for the University of Delaware and the University of Chicago to share deidentified SPEAK-R and demographic data including: parent participant's age in years, highest level of school completed/highest degree obtained, race, and ethnicity age in years and highest level of school completed/highest degree obtained for other adult(s) living in the household, infant participant's race, ethnicity, and sex, and approximate total annual household income before taxes which the University of Chicago will use towards establishing the reliability of the SPEAK-R and publishing research articles.