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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04576481
Other study ID # 19-017199
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)

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. — View Citation

Blair C, Raver CC. Poverty, Stress, and Brain Development: New Directions for Prevention and Intervention. Acad Pediatr. 2016 Apr;16(3 Suppl):S30-6. doi: 10.1016/j.acap.2016.01.010. Review. — View Citation

Cates CB, Dreyer BP, Berkule SB, White LJ, Arevalo JA, Mendelsohn AL. Infant communication and subsequent language development in children from low-income families: the role of early cognitive stimulation. J Dev Behav Pediatr. 2012 Sep;33(7):577-85. doi: 10.1097/DBP.0b013e318264c10f. — View Citation

Centers for Disease Control and Prevention (CDC). Economic costs associated with mental retardation, cerebral palsy, hearing loss, and vision impairment--United States, 2003. MMWR Morb Mortal Wkly Rep. 2004 Jan 30;53(3):57-9. — View Citation

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.

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. — View Citation

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

Jacobson Vann JC, Jacobson RM, Coyne-Beasley T, Asafu-Adjei JK, Szilagyi PG. Patient reminder and recall interventions to improve immunization rates. Cochrane Database Syst Rev. 2018 Jan 18;1:CD003941. doi: 10.1002/14651858.CD003941.pub3. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

National Research Council and Institute of Medicine. From neurons to neighborhoods: the science of early childhood development. Committee on Integrating the Science of Early Childhood Development. Washington, DC: National Academy Press; 2000.

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

O'Leary ST, Lee M, Lockhart S, et al. Effectiveness and Cost of Bidirectional Text Messaging for Adolescent Vaccines and Well Care. Pediatrics. 2015;136(5):e20151089. Pediatrics. 2016 Sep;138(3). pii: e20161768. doi: 10.1542/peds.2016-1768. — View Citation

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.

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

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. — View Citation

Rosenberg SA, Zhang D, Robinson CC. Prevalence of developmental delays and participation in early intervention services for young children. Pediatrics. 2008 Jun;121(6):e1503-9. doi: 10.1542/peds.2007-1680. Epub 2008 May 26. — View Citation

Senechal M, Lefevre J, Thomas EM, Daley KE. Differential effects of home literacy experiences on the development of oral and written language. Reading Res Q. 1998;33:96-116.

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. Erratum in: JAMA Pediatr. 2017 Aug 1;171(8):814. — View Citation

The pediatrician's role in development and implementation of an Individual Education Plan (IEP) and/or an Individual Family Service Plan (IFSP). American Academy of Pediatrics. Committee on Children with Disabilities. Pediatrics. 1999 Jul;104(1 Pt 1):124-7. — View Citation

Weinberger J. A longitudinal study of children's early literacy experiences at home and later literacy development at home and school. J Res Reading. 1996;19:14-24.

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:CD006611. doi: 10.1002/14651858.CD006611.pub5. [Epub ahead of print] Review. — View Citation

Zuckerman B, Augustyn M. Books and reading: evidence-based standard of care whose time has come. Acad Pediatr. 2011 Jan-Feb;11(1):11-7. doi: 10.1016/j.acap.2010.09.007. — View Citation

* Note: There are 25 references in allClick 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
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