Study Results
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View full resultsBasic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2020-11-17
2022-02-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Group 1: Texting
Consist of daily text messages on shared reading
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.
Group 2: Regret
Will consist of Group 1 plus social comparisons.
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.
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.
Group 3: Lottery
Will consist of Group 2 plus availability of a weekly lottery.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
\- 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
6 Months
24 Months
ALL
Yes
Sponsors
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University of Pennsylvania
OTHER
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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James Guevara, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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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/
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.
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.
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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.
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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.
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.
Powell G, Mackrain M, LeBuffe P. Devereux Early Childhood Assessment for Infants and Toddlers- Technical Manual. Lewisville, NC: Kaplan Early Learning Corporation;2007.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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19-017199
Identifier Type: -
Identifier Source: org_study_id
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