NCT04576481: LP

Literacy Promotion Using Automated Hovering

Completed NA Results posted Last updated 15 November 2024

What this trial tests

NA trial testing Texting in Parent-Child Relations in 55 participants. Completed in 4 February 2022.

Timeline

17 November 2020

Primary endpoint
4 February 2022

4 February 2022

Quick facts

Lead sponsor	Children's Hospital of Philadelphia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	55
Start date	17 November 2020
Primary completion	4 February 2022
Estimated completion	4 February 2022
Sites	1 location across United States

Drugs / interventions tested

• Texting
• Regret
• Lottery

Conditions studied

• Parent-Child Relations — all drugs for Parent-Child Relations →
• Parenting — all drugs for Parenting →
• Literacy — all drugs for Literacy →

Sponsor

Children's Hospital of Philadelphia

Who can join

Adults 6 Months to 24 Months, any sex, with Parent-Child Relations or Parenting. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Acceptability Survey Primary · 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.

Group	Value	95% CI
Phase 2 Texting Arm: Text Messaging	4	± 1.1
Phase 2 Regret Arm: Text Messaging + Coaching	3.3	± 1.3
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery	3.8	± 1.2

Feasibility of Study Primary · 2 months

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

Group	Value	95% CI
Phase 2 Texting Arm: Text Messaging Only	14
Phase 2 Regret Arm: Text Messaging + Coaching	13
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery	15
Phase 1	10

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

Group	Value	95% CI
Phase 2 Texting Arm: Text Messaging	1.8	± 2.8
Phase 2 Regret Arm: Text Messaging + Coaching	3.2	± 4.0
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery	1.3	± 2.7

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

Group	Value	95% CI
Phase 2 Texting Arm: Text Messaging	2.2	± 18.2
Phase 2 Regret Arm: Text Messaging + Coaching	5.3	± 16.4
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery	9	± 34.5

Change in Weekly Parent-Child Shared Reading Frequency Secondary · 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.

Days per week reading at baseline

Group	Value	95% CI
Phase 2 Texting Arm: Text Messaging	4.1	± 1.8
Phase 2 Regret Arm: Text Messaging + Coaching	4.0	± 1.8
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery	4.8	± 1.5

Days per week reading at 2-month follow-up

Group	Value	95% CI
Phase 2 Texting Arm: Text Messaging	3.9	± 2.0
Phase 2 Regret Arm: Text Messaging + Coaching	4.2	± 1.7
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery	4.9	± 1.5

Change in reading frequency (days per week

Group	Value	95% CI
Phase 2 Texting Arm: Text Messaging	-0.3	± 2.2
Phase 2 Regret Arm: Text Messaging + Coaching	0.2	± 2.6
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery	0.1	± 1.7

Measure of Child Socio-Emotional Development Using Devereux Early Childhood Assessment (DECA) Secondary · 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 a

Initiative Score

Group	Value	95% CI
Control: Text Messaging	77.6	± 18.7
Regret Arm: Text Messaging + Coaching	64.3	± 27.3
Lottery Arm: Text Messaging + Coaching + Lottery	72.1	± 28.6

Attachment/Relationship Score

Group	Value	95% CI
Control: Text Messaging	79.4	± 19.4
Regret Arm: Text Messaging + Coaching	66.6	± 31.2
Lottery Arm: Text Messaging + Coaching + Lottery	75.6	± 27.8

Measure of Child Language Development Using MacArthur Communicative Development Inventory (CDI) - Percentiles Secondary · 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) an

Group	Value	95% CI
Phase 2 Texting Arm: Text Messaging	84.6	± 29.7
Phase 2 Regret Arm: Text Messaging + Coaching	78.5	± 33.2
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery	63.1	± 42.6

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.