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Completed

NCT Number: NCT04576481

Literacy Promotion Using Automated Hovering

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.

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Key information

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Texting

Behavioral

Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.

Regret

Behavioral

Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.

Lottery

Behavioral

Participants who reply to a text message that they read on a particular day will be entered into daily and weekly drawings to receive cash payments.

Primary outcomes

  1. Acceptability Survey

    Time frame: 2 months

    To determine acceptability, participants will be assessed on their overall satisfaction (5-point Likert scale 1=strong disagree, 2=disagree, 3=not sure, 4=agree and 5= strongly agree) with the study delivery intervention and answered survey questions regarding likes and dislikes concerning the intervention group they received following the intervention period.

  2. Feasibility of Study

    Time frame: 2 months

    Percentage of study participants who completed the 2-month follow-up

Secondary outcomes

  1. Change in Score of Cognitive Stimulation Provided in the Home Measure - (StimQ-Read)

    Time frame: 2 months

    To determine change in home reading environment, Investigators will examine differences in the Read subscale of the measure of Cognitive Stimulation provided in the home (StimQ) from baseline to 2 months. The Read subscale of the StimQ is a validated 14-item parent self-report questionnaire designed to measure of the home reading environment for children ages 5 to 72 months of age with a maximum score of 18 and a minimum score of 0. The higher score indicates a better home reading environment. The change in score from baseline to follow-up (2-months) will be used.

  2. Change in Score for The Parenting Stress Index - Short Form (PSI-SF)

    Time frame: 2 months

    To determine change in parenting stress, Investigators will examine differences in the Parenting Stress Index- Short Form (PSI-SF) from baseline to follow-up (2 months). The PSI-SF is a validated 36-item scale that measures parenting stress, and it has been shown to have excellent internal consistency and to be positively associated with maternal psychological distress. The scores can range from 36 to 180 with an higher scores overall indicating higher levels of parenting stress. The change in score from baseline to follow-up (2-months) will be used.

  3. Change in Weekly Parent-Child Shared Reading Frequency

    Time frame: 2 months

    Investigators will measure reading frequency as the average number of days per week of reported parent-child shared reading.

    This is a measure of parent's self-reported reading frequency using question 2 from Cognitive Stimulation Provided in the Home Measure Reading Subscales, Parents are asked "How many days each week do you read children's books to your child?". Scores will be collected at baseline and at the 2-month follow-up. Change in reading frequency will be computed by subtracting the days reading at baseline from the days reading at follow-up.

  4. Measure of Child Socio-Emotional Development Using Devereux Early Childhood Assessment (DECA)

    Time frame: 2 months

    Investigators will measure child socio-emotional development at 2 months using the Devereax Early Childhood Assessment (DECA), a validated 33-item parent report of social emotional problems for children 9-36 months of age. All 33 items are used to calculate the raw total protective factor (TPF). 18/33 items are used to calculate raw Initiative sub scale (infant's ability to use independent thought and action to meet his/her needs). 15/33 items are used to calculate raw Attachment/Relationships sub scale (mutual, strong, long-lasting relationship between the infant and significant adults such as family members, and teachers). Higher scores indicate greater social emotional development.

    For all 33 items parents can report (Never 0, Rarely 1, Occasionally 2, Frequently 3, Very Frequently 4). Raw total scores can range from 0-132, with higher scores indicating a better outcome.

  5. Measure of Child Language Development Using MacArthur Communicative Development Inventory (CDI) - Percentiles

    Time frame: 2 months

    Investigators measured child language development at 2 months using the MacArthur Communicative Development Inventory (CDI), a validated parent report scale of early child language development for children 8-30 months of age. Parents are asked to indicate the words their child understands but does not yet say in the first column (understands). For words that their child understands, Parents are asked to indicate which words their child says in the second column (understand and says).

    The raw total scores are inputted into a norming table for the CDI where a production (understand and says) and comprehension (understands) scores are generated based on the child's age and gender. Total scores can range from (0-178) with higher scores on the norming chart correlating to a higher percentile in comprehension or production. Total score is calculated by using summed scores where: blank = 0, understands = 1 and understands and speaks=2. Total scores were converted to percentile scores.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • University of Pennsylvania

Registry information

Official study title

Literary Promotion Using Automated Hovering to Improve Development in Young Low-Income Children

Acronym: LP

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 6, 2020
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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