An interventional study of Enriched Education Program and Typical Education Program in Infant Development and Developmental Delay, sponsored by University of Delaware. Completed at 1 site in United States. Open to participants aged 1 Month to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by University of Delaware · Not applicable, Interventional, and Treatment
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.
Parents are the primary source of interaction for their infants; they determine their infants' daily experiences and provide opportunities for growth and learning that have cascading, longitudinal effects. Early experiences may be even more important for infants who are at risk of developmental delays. In the United States, one out of every six children ages 3-17 will be diagnosed with one or multiple developmental disabilities, and the prevalence is growing. While some children with developmental disabilities or delays benefit from early intervention (EI) services in this critical period, enrollment rates for eligible children are disturbingly low, with only 5-10% of children with delays receiving EI services at 24 months of age. For these children who do not receive EI services during this critical window for neuroplasticity and learning, parents are the primary persons tasked with independently creating opportunities for their infants' developmental growth. The purpose of this study is to improve our understanding of early parent education and to determine whether or how parent education changes child outcomes (i.e., developmental scores) and parental characteristics (i.e., physical and social setting, customs, parent psychology). The investigators will conduct a pilot randomized controlled trial with a parallel design enrolling parents and infants ages 1-6 months with typical development or with/at risk of developmental delays. The investigators will use blocked randomization to control for socioeconomic status, as this is a known factor that can impact infant development, to assign parent-infant dyads to receive either the Enriched Education Program (EEP) or the Typical Education Program (TEP). Parents will receive written, illustrated instructions describing nine play activities; they will be asked to perform three activities each day (5 minutes each, 15 minutes total per day), logging their activity for 4 weeks. EEP activities were designed to implement EI and developmental science principles, while TEP activities represent common activities described on parenting websites, books, and mobile applications. Participants will be evaluated longitudinally across five visits using a variety of measures of child development and parental characteristics: at pre-intervention (baseline), post-intervention (1 month), and at follow-up visits (1-, 2-, and 5-month follow-up). In addition, infants' motor milestone development will be tracked through the onset of walking. The effect of the interventions on child developmental outcomes and parental characteristics will be evaluated for infants with typical development and infants at risk/with developmental delays. Usability of the educational programs will also be evaluated. The results of this study may help inform future parent education interventions.
University of Delaware is the lead sponsor of 125 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
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.
Other: 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 typical play education based on usual education found in commonly used websites, apps, and books.
Other: 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 enriched play activity education based on key ingredients evidenced to advance infant development.
Other: 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 typical play education based on usual education found in commonly used websites, apps, and books.
Other: Typical Education Program
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.
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
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
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.
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
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.
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
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.
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
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).
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
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).
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
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.
Time frame: 1-month from start of study
Change in Daily Positioning
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.
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
Change in Infant Object Exploration
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).
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
Change in Language Development
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.
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
Change in Parental Beliefs about Development
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).
Time frame: 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
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).
Time frame: Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
Change in Parent Beliefs and Knowledge about Play
The Parent Play Questionnaire will survey parents' beliefs and knowledge about play with infants.
Time frame: Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
Change in Parenting Confidence
The Karitane Parenting Confidence Scale will assess parents' confidence in their parenting abilities. Higher scores indicate greater 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
Change in Parental Practices regarding Motor Development
The Motor Habits Questionnaire will be used to measure parents' practices regarding motor development.
Time frame: Baseline (start of study), 3-months from start of study, 6-months from start of study
Change in the Time of Achieving Developmental Milestones
The Parental Milestone Report will be used to track the timing of the development of key developmental milestones through the onset of independent walking.
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)
Affordances in the Home Environment Impact Child Developmental Outcomes and Parental Characteristics
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.
Time frame: Baseline (start of study)
Plan to share: Yes — 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.
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