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

NCT ID: NCT05259423

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-11-10

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.

Conditions

Infant Development; Developmental Delay

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Enriched Education Program

Intervention Type: OTHER

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 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.

Group Type: ACTIVE_COMPARATOR

Typical Education Program

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Enriched Education Program

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Typical Education Program

Intervention Type: OTHER

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.

Interventions

Enriched 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.

Intervention Type: OTHER

Typical Education Program

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Delaware

OTHER

Sponsor Role: lead

Responsible Party

Michele Lobo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele A Lobo, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Delaware

Locations

University of Delaware

Newark, Delaware, United States

Countries

United States

Other Identifiers

1858581-1

Identifier Type: -

Identifier Source: org_study_id