Clinical trial NCT05259423: The Effects on Children and Parents of Educating Parents About Ways to Play With Babies
Official title: The Effects on Children and Parents of Educating Parents About Ways to Play With Babies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Developmental Delay
Keywords: Education
Parents
Infant
Motor Activity
Cognition
Infant development
language development
Infant health
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 49
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to receive the Enriched Education Program (EEP) or the Typical Education Program (TEP).
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: Usability and Feasibility of the Intervention
timeFrame: 1-month from start of study
Secondary outcomes:
measure: Change in Daily Positioning
timeFrame: 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
measure: Change in Infant Object Exploration
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
measure: Change in Language 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
measure: Change in Parental Beliefs about Development
timeFrame: Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
measure: Change in Parental Knowledge about Development
timeFrame: Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
measure: Change in Parent Beliefs and Knowledge about Play
timeFrame: Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
measure: Change in Parenting Confidence
timeFrame: Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
measure: Change in Parental Practices regarding Motor Development
timeFrame: Baseline (start of study), 3-months from start of study, 6-months from start of study
measure: Change in the Time of Achieving Developmental Milestones
timeFrame: 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)
Other outcomes:
measure: Affordances in the Home Environment Impact Child Developmental Outcomes and Parental Characteristics
timeFrame: Baseline (start of study)
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Michele A Lobo, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: