Literacy Promotion Using Automated Hovering

NCT04576481 | Completed Results

• 1 other identifier: 19-017199
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Parent-Child Relations; Parenting; Literacy

Outcome Measures

Primary Outcomes (2)

• Acceptability Survey

  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

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

  2 months

Secondary Outcomes (5)

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

  2 months

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

  2 months

• Change in Weekly Parent-Child Shared Reading Frequency

  2 months

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

  2 months

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

  2 months

Study Arms (3)

Group 1: Texting

ACTIVE COMPARATOR

Consist of daily text messages on shared reading

Behavioral: Texting

Group 2: Regret

EXPERIMENTAL

Will consist of Group 1 plus social comparisons.

Behavioral: Texting; Behavioral: Regret

Group 3: Lottery

EXPERIMENTAL

Will consist of Group 2 plus availability of a weekly lottery.

Behavioral: Texting; Behavioral: Regret; Behavioral: Lottery

Interventions

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.

Group 1: Texting; Group 2: Regret; Group 3: Lottery

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.

Group 2: Regret; Group 3: Lottery

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.

Group 3: Lottery

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (25)

• National Research Council (US) and Institute of Medicine (US) Committee on Integrating the Science of Early Childhood Development; Shonkoff JP, Phillips DA, editors. From Neurons to Neighborhoods: The Science of Early Childhood Development. Washington (DC): National Academies Press (US); 2000. Available from http://www.ncbi.nlm.nih.gov/books/NBK225557/

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  PMID: 27044699 BACKGROUND

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  PMID: 10390275 BACKGROUND

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  PMID: 14749614 BACKGROUND

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  PMID: 22947884 BACKGROUND

• Hart B, Risley TR. Meaningful differences in the everyday experience of young American children. Baltimore, MD: Paul Brookes Publishing Company; 1995.

  BACKGROUND

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  PMID: 21272819 BACKGROUND

• Payne AC, Whitehurst GJ, Angell aL. The role of home literacy environment in the development of language ability in preschool children from low-income families. Early Child Res Q. 1994:427-440.

  BACKGROUND

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  BACKGROUND

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  BACKGROUND

• Jimenez ME, Mendelsohn AL, Lin Y, Shelton P, Reichman N. Early Shared Reading Is Associated with Less Harsh Parenting. J Dev Behav Pediatr. 2019 Sep;40(7):530-537. doi: 10.1097/DBP.0000000000000687.

  PMID: 31107765 BACKGROUND

• Jimenez ME, Hudson SV, Lima D, Mendelsohn AL, Pellerano M, Crabtree BF. Perspectives on shared reading among a sample of Latino parents. Child Care Health Dev. 2019 Mar;45(2):292-299. doi: 10.1111/cch.12634. Epub 2018 Dec 19.

  PMID: 30471139 BACKGROUND

• Mendelsohn AL, Mogilner LN, Dreyer BP, Forman JA, Weinstein SC, Broderick M, Cheng KJ, Magloire T, Moore T, Napier C. The impact of a clinic-based literacy intervention on language development in inner-city preschool children. Pediatrics. 2001 Jan;107(1):130-4. doi: 10.1542/peds.107.1.130.

  PMID: 11134446 BACKGROUND

• Asch DA, Muller RW, Volpp KG. Automated hovering in health care--watching over the 5000 hours. N Engl J Med. 2012 Jul 5;367(1):1-3. doi: 10.1056/NEJMp1203869. Epub 2012 Jun 20. No abstract available.

  PMID: 22716935 BACKGROUND

• Whittaker R, McRobbie H, Bullen C, Rodgers A, Gu Y, Dobson R. Mobile phone text messaging and app-based interventions for smoking cessation. Cochrane Database Syst Rev. 2019 Oct 22;10(10):CD006611. doi: 10.1002/14651858.CD006611.pub5.

  PMID: 31638271 BACKGROUND

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  PMID: 29342498 BACKGROUND

• Taveras EM, Marshall R, Sharifi M, Avalon E, Fiechtner L, Horan C, Gerber MW, Orav EJ, Price SN, Sequist T, Slater D. Comparative Effectiveness of Clinical-Community Childhood Obesity Interventions: A Randomized Clinical Trial. JAMA Pediatr. 2017 Aug 7;171(8):e171325. doi: 10.1001/jamapediatrics.2017.1325. Epub 2017 Aug 7.

  PMID: 28586856 BACKGROUND

• Ladley A, Hieger AW, Arthur J, Broom M. Educational Text Messages Decreased Emergency Department Utilization Among Infant Caregivers: A Randomized Trial. Acad Pediatr. 2018 Aug;18(6):636-641. doi: 10.1016/j.acap.2018.02.003. Epub 2018 Feb 9.

  PMID: 29432907 BACKGROUND

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  PMID: 27581853 BACKGROUND

• NICHD Strategic Plan 2020. NIH Pub Number 19-HD-8091. Bethesda, MD: Eunice Kennedy Shriver National Institute of Child Health and Human Development;2019.

  BACKGROUND

• Dreyer BP, Mendelsohn AL, Tamis-LeMonda CS. Assessing the child's cognitive home environment through parental report: reliability and validity. Early Dev Parent. 1996;5:271-287.

  BACKGROUND

• Reitman D, Currier RO, Stickle TR. A critical evaluation of the Parenting Stress Index-Short Form (PSI-SF) in a head start population. J Clin Child Adolesc Psychol. 2002 Sep;31(3):384-92. doi: 10.1207/S15374424JCCP3103_10.

  PMID: 12149976 BACKGROUND

• Powell G, Mackrain M, LeBuffe P. Devereux Early Childhood Assessment for Infants and Toddlers- Technical Manual. Lewisville, NC: Kaplan Early Learning Corporation;2007.

  BACKGROUND

• Feldman HM, Dollaghan CA, Campbell TF, Kurs-Lasky M, Janosky JE, Paradise JL. Measurement properties of the MacArthur communicative development inventories at ages one and two years. Child Dev. 2000 Mar-Apr;71(2):310-22. doi: 10.1111/1467-8624.00146.

  PMID: 10834466 BACKGROUND

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

Communication; Behavior

Limitations and Caveats

* Technical issues with W2H system: Group 2 texts that provided comparisons of participant reading frequency with that of other participant did not work properly for duration of study. * Problem with Measurements leading to lost data: * CDI \& DECA: data lost for participants \>18 mo at follow-up visit * CDI: technical problems with RedCap data collection. Comprehension scores are uninterpretable. Only production scores were used in data analysis.

Results Point of Contact

• Title: James Guevara, MD MPH
• Organization: Children's Hospital of Philadelphia

guevara@chop.edu

215-590-1130

Study Officials

• James Guevara, MD, MPH

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will not be blinded to their treatment assignment. However, research staff will be blinded to treatment assignment when collecting study data.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 6, 2020
• Study Start: November 17, 2020
• Primary Completion: February 4, 2022
• Study Completion: February 4, 2022
• Last Updated: November 15, 2024
• Results First Posted: November 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 12 months after the end of the final year of funding.
• Access Criteria: REDCap access

Locations

US (1)