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

Infant Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05259423
• Other study ID #: 1858581-1
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: November 10, 2023

Study information

• Verified date: May 2024
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 10, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Developmental Delay
• Infant Development

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline (start of study)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	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
Secondary	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).	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
Secondary	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.	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
Secondary	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).	Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
Secondary	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).	Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
Secondary	Change in Parent Beliefs and Knowledge about Play	The Parent Play Questionnaire will survey parents' beliefs and knowledge about play with infants.	Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
Secondary	Change in Parenting Confidence	The Karitane Parenting Confidence Scale will assess parents' confidence in their parenting abilities. Higher scores indicate greater parenting confidence.	Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
Secondary	Change in Parental Practices regarding Motor Development	The Motor Habits Questionnaire will be used to measure parents' practices regarding motor development.	Baseline (start of study), 3-months from start of study, 6-months from start of study
Secondary	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.	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)