Literacy Promotion Using Automated Hovering

Parenting Clinical Trial

— LP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04576481
• Other study ID #: 19-017199
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: December 2021

Study information

• Verified date: September 2021
• Source: Children's Hospital of Philadelphia
• Contact: James Guevara, MD, MPH
• Phone: 215-590-1130
• Email: guevara[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to incorporate behavioral economics approaches to determine whether 3 novel interventions of varying intensity improve the frequency of parent-child reading behaviors among low-income families. Participants will be randomized to comparative groups to test the effects of automated hovering 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.

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 prospective, randomized comparative group trial to test the effects of AH approaches to increase parent-child shared reading. A total of 45 eligible children and their parents will be recruited from participating practices to achieve a diverse sample of children.

Forty-five participants in will be randomized 1:1:1 to receive one of the 3 AH interventions:

1) daily text message reminders, 2) daily text message reminders with coaching/social comparisons or 3) daily text message reminders with coaching/social comparisons and weekly lottery entries. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

Inclusion Criteria:

Parents who:

1. Have an infant aged 6-24 months

2. Have access to a smart phone with text messaging capabilities

3. Have completed an informed consent

Children who:

4. Are aged 6-24 months old

Exclusion Criteria:

Parents who:

1. Non-English speaking

Children who:

1. Were born premature (estimated gestational age < 35 weeks)

2. Have been diagnosed with congenital malformations or genetic syndromes which place them at risk for developmental delays

Related Conditions & MeSH terms

• Literacy
• Parent-Child Relations
• Parenting

Intervention

Behavioral:
• Text Messaging
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.
• Coaching
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
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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Leonard Davis Institute of Health Economics, University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who respond to the intervention delivery	To determine feasibility, investigators will assess the number of participants who respond to daily text messages in each study arm, who access the coaching content in groups 2 and 3, and who participate in the lottery in group 3.	2 months
Primary	Overall participant satisfaction of intervention delivery	To determine acceptability, participants will be assessed on their overall satisfaction (5-point Likert scale 1=strong disagree and 5= strongly agree) with their study arm and answer survey questions regarding likes and dislikes concerning the intervention group they received following the intervention period.	2 months
Secondary	Change in Home Reading Environment	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.	2 months
Secondary	Change in Parenting Stress	To determine change in parenting stress, Investigators will examine differences in the Parenting Stress Index- Short Form (PSI-SF) from baseline to 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.	2 months
Secondary	Weekly Parent-Child Shared Reading Frequency	Investigators will measure reading frequency as the average number of days per week of reported parent-child shared reading. Reading frequency will be determined by responses to daily text message reminders that report reading with a book title and duration.	2 months
Secondary	Child Language Development	Investigators will measure child language development at 2 months using the MacArthur Communicative Development Inventory (CDI), a validated parent report scale of early child language development.	2 months
Secondary	Child Socio-Emotional Development	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.	2 months