Clinical trial NCT04576481: Literacy Promotion Using Automated Hovering
Official title: Literary Promotion Using Automated Hovering to Improve Development in Young Low-Income Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent-Child Relations
Parenting
Literacy
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2020-10-06
Enrollment: 55
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention consists of 3 intervention groups. Participants will be stratified by site and randomized 1:1:1 to receive one of the 3 AH interventions for an 8-week duration.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to incorporate behavioral economics (BE) approaches to determine whether 3 novel interventions of varying intensity improve the frequency of parent-child reading behaviors among low-income families. In the first phase, 10 parents will be recruited to participate in rapid cycle interviews to determine the appropriateness of text messages. In the second phase, 45 participants will be randomized to comparative groups to test the effects of automated hovering and other BE approaches on frequency of parent-child shared reading. Investigators long-term goal is to test the effects of these approaches to promote child language and socio-emotional development.

Detailed description: Early childhood is a sensitive period in which young children develop language and socio-emotional skills foundational for school readiness. Unfortunately, poor vulnerable children experience disparities in these critical areas of development. Parent-child shared reading can help ameliorate these disparities, yet low-income parents do not consistently engage in this activity. Behavioral economics approaches utilizing automated hovering (AH) have the potential to increase parent-child shared reading through text messages and financial inducements.

The study design is a two-phase study consisting of a qualitative component followed by a prospective, randomized comparative group trial to test the effects of AH approaches to increase parent-child shared reading. A total of 55 eligible children and their parents will be recruited from participating practices to achieve a diverse sample of children.

In the first phase, 10 parents will be recruited to participate in brief rapid cycle interviews to assess the appropriateness of text message reminders. In the second phase, forty-five participants will be randomized 1:1:1 to receive one of the 3 AH interventions: 1) daily text message reminders (texting), 2) daily text message reminders with social comparisons (regret) or 3) daily text message reminders with social comparisons and weekly lottery entries (lottery). All interventions are related to principles of behavioral economics in order to provide external motivation. There will be 15 participants per group to adequately assess feasibility and acceptability, the primary outcome.

Descriptive statistics for demographic, home reading environment, and parenting stress measured at baseline will be examined across the three groups to assess the success of the randomization. To assess feasibility and acceptability, Investigators will assess the proportion of participants who receive and report a daily reading behavior each week across all groups, the proportion of participants who access coaching content in group 2 \& 3, and the proportion of participants who participate in the weekly lottery in group 3, and satisfaction scores in all groups. Secondary outcomes including differences between groups in weekly reading frequency, home reading environment, and child socio-emotional scores between groups will be assessed using standard inferential statistics and intention-to-treat analysis.

The results of this study may assist health care providers and researchers in testing the feasibility of AH approaches to improve parent-child shared reading and prepare for a larger efficacy trial.

Eligibility criteria: Inclusion Criteria:

* Parents who:

  * Have an infant aged 6-24 months
  * Have access to a smart phone with text messaging capabilities
  * Have completed an informed consent
* Children who:

  * Are aged 6-24 months old

Exclusion Criteria:

* Parents who:

  - Non-English speaking
* Children who:

  * Were born premature (estimated gestational age \< 35 weeks)
  * Have been diagnosed with congenital malformations or genetic syndromes which place them at risk for developmental delays

Primary outcomes:
measure: Acceptability Survey
timeFrame: 2 months
measure: Feasibility of Study
timeFrame: 2 months
Secondary outcomes:
measure: Change in Score of Cognitive Stimulation Provided in the Home Measure - (StimQ-Read)
timeFrame: 2 months
measure: Change in Score for The Parenting Stress Index - Short Form (PSI-SF)
timeFrame: 2 months
measure: Change in Weekly Parent-Child Shared Reading Frequency
timeFrame: 2 months
measure: Measure of Child Socio-Emotional Development Using Devereux Early Childhood Assessment (DECA)
timeFrame: 2 months
measure: Measure of Child Language Development Using MacArthur Communicative Development Inventory (CDI) - Percentiles
timeFrame: 2 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: James Guevara, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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