Literacy Promotion Using Automated Hovering (LP)

September 10, 2024 updated by: Children's Hospital of Philadelphia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: Texting
Consist of daily text messages on shared reading
Behavioral: Texting
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.
Experimental: Group 2: Regret
Will consist of Group 1 plus social comparisons.
Behavioral: Texting
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.
Behavioral: Regret
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.
Experimental: Group 3: Lottery
Will consist of Group 2 plus availability of a weekly lottery.
Behavioral: Lottery
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.
Behavioral: Texting
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.
Behavioral: Regret
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months
Feasibility of Study
Time Frame: 2 months
Percentage of study participants who completed the 2-month follow-up
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months
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.
2 months
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.
2 months
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.
2 months
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

University of Pennsylvania
Leonard Davis Institute of Health Economics

Investigators

  • Principal Investigator: James Guevara, MD, MPH, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2020

Primary Completion (Actual)

February 4, 2022

Study Completion (Actual)

February 4, 2022

Study Registration Dates

First Submitted

September 25, 2020

First Submitted That Met QC Criteria

October 5, 2020

First Posted (Actual)

October 6, 2020

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

September 10, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 19-017199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A complete, cleaned, and de-identified dataset will be made available to other investigators after all analyses have been conducted and within twelve months of the end of the final year of funding to allow for publication of all study aims. To obtain this data set, other investigators will need to contact the study Principal Investigator (PI) who will provide a data sharing agreement. The data sharing agreement will permit a deidentified data set to be shared once an Institutional Review Board (IRB) protocol has been approved at the investigators' home institution and the investigators have signed a pledge to not attempt to identify individual study subjects. The data set will be made available on a Compact Disc Read-Only Memory (CD-ROM) or through a secure File Transfer Protocol (FTP) site.

IPD Sharing Time Frame

12 months after the end of the final year of funding.

IPD Sharing Access Criteria

REDCap access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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