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Rx for Success: RCT of an App for Dialogic Reading Training

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ClinicalTrials.gov Identifier: NCT03828721
Recruitment Status : Completed
First Posted : February 4, 2019
Last Update Posted : June 16, 2020
Sponsor:
Collaborators:
Reach Out and Read National Office
Connecticut Children's Medical Center
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date  ICMJE March 5, 2018
First Posted Date  ICMJE February 4, 2019
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE March 20, 2018
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • Language [ Time Frame: 6 months ]
    Comparison of scores on the LENA Snapshot parent report measure before and after DR intervention between intervention and control groups.
  • Social-emotional [ Time Frame: 6 months ]
    Comparison of scores on items exerpted from the DECA-I/T Measure, attachment sub scale between intervention and control groups.
  • Home reading behaviors [ Time Frame: 6 months ]
    Comparison of scores on items exerpted from the StimQ-I/T and DialogPR-IT measures between intervention and control groups.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
Screen-based media use [ Time Frame: 6 months ]
Comparison of ScreenQ scores (screen-based media use at home) between intervention and control groups.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rx for Success: RCT of an App for Dialogic Reading Training
Official Title  ICMJE Rx for Success: A Randomized Controlled Trial of Technology-Based Dialogic Reading Training
Brief Summary

The purpose of this randomized controlled trial is to explore the efficacy of amplifying dialogic reading training provided to families of infants and toddlers in the ROR program using a novel, smartphone-based application (Rx for Success; RS). The RS app includes videos modeling dialogic reading for a variety of child ages, interactive games, and text messaging reminders to empower parents and other caregivers to increase constructive cognitive and social-emotional stimulation in the home through book sharing. This study addresses an evidence gap regarding the efficacy of dialogic reading training to improve cognitive and social-emotional health using a mobile, technology-based approach. It leverages existing ROR infrastructure and will provide valuable pilot data to improve and scale this inexpensive clinical resource and guide future longitudinal studies, to better serve low-SES, at-risk families.

Aims and hypotheses are as follows:

Specific Aim 1 (Rx for Success; RS): To explore the efficacy of incorporating dialogic reading training via the RS application into ROR during well-child visits for infants (6-12 months old) and toddlers (18-24 months old), compared to standard ROR practice.

Hypothesis 1a (language): Language scores (LENA Snapshot) will be higher in children whose caregivers are provided with the RS app.

Hypothesis 1b (social-emotional): Social-emotional development scores (DECA-I/T items) will be higher in children whose caregivers are provided with the RS app.

Hypothesis 1c (dialogic quality): Dialogic reading quality scores (DialogPR) will be higher in caregivers presented with the RS app.

Hypothesis 1d (attitudes): Attitudes towards shared reading at home (StimQ-I/T items) will be higher in families provided with the RS app.

Specific Aim 2 (exploratory): To explore the effect of providing a smartphone-based app versus a specially designed children's book on screen-based media use.

Hypothesis 2a: Reported screen-based media use (ScreenQ) will be lower in families provided with the RS app, reflecting greater emphasis on interactive shared reading.

Hypothesis 2b: Language (LENA Snapshot) and social-emotional (DECA-I/T items) scores will be higher for children with less reported screen-based media use (ScreenQ).

Detailed Description

Shared reading, most often between a parent and child, has been described as "the single most important activity for developing the knowledge required for eventual success in reading." The American Academy of Pediatrics (AAP) recommends daily shared reading beginning as soon as possible after birth. Shared reading occurs in the context of home reading environment, comprised of quantitative factors such as access to books and reading frequency, and qualitative factors such as verbal interactivity and engagement during shared reading. Each of these are addressed by the Reach Out and Read (ROR) program, a population-level, evidence-based intervention based in pediatric primary care clinics. ROR serves low-socioeconomic status (SES) families at-risk for adverse outcomes during a critical span of cognitive, social-emotional and underlying brain development between birth and age 5, when children typically enter kindergarten. The ROR model is for practitioners to capitalize on their privileged access to families with young children during well-child visits to provide a new, age-appropriate children's book, developmental screening related to early literacy skills, and encouragement for families to read together.

Dialogic reading is a method of shared reading that promotes reciprocal dialogue between a caregiver and child, originally developed for low-SES families where such interactivity is often lacking, a major contributor to the widely cited "30-million word gap." The dialogic approach involves specific types of prompts, responses, and references to the child's life, sophistication increasing with age and ability, with the ultimate goal of the child "becoming the reader." Behavioral evidence suggests that dialogic reading may confer moderate to large benefits beginning in infancy, especially in children from low-SES households. These include oral language, narrative comprehension, print concepts, and attention, which are foundational emergent literacy skills. Social-emotional benefits have also been shown, including increased parent-child bonding, pro-social behavior11 and enjoyment of reading. Recent neuroimaging-based studies have also found positive correlation between shared reading quality applying dialogic criteria and brain function supporting emergent literacy in preschool-age children.

A dose-response effect of dialogic reading has been suggested, manifest through greater adherence and practice. However, shared reading quality ("dialogic-ness") tends to be particularly low in low-SES households, attributed to deficient reading abilities, role models, and routines. Several approaches to dialogic reading intervention have been shown to be effective, including video-based training, especially when supplemental instruction and practice are provided to optimize and sustain learning. The ROR program encourages primary care providers to advocate and model dialogic reading during well-child visits, though in practice this can be challenging, given time, reimbursement and other constraints. Thus, despite improved outcomes, there is a need to amplify the ROR intervention in a time-efficient way to address the persistent readiness gap between low-income and more affluent children.

The purpose of this randomized controlled trial is to explore the efficacy of amplifying dialogic reading training provided to families of infants and toddlers in the ROR program using a novel, smartphone-based application (Rx for Success; RS). The RS app includes videos modeling dialogic reading for a variety of child ages, interactive games, and text messaging reminders to empower parents and other caregivers to increase constructive cognitive and social-emotional stimulation in the home through book sharing. This study addresses a major evidence gap regarding the efficacy of dialogic reading training to improve cognitive and social-emotional health using a mobile, technology-based approach. It leverages existing ROR infrastructure and will provide valuable pilot data to improve and scale this inexpensive clinical resource and guide future longitudinal studies, to better serve low-SES, at-risk families.

This is a prospective, randomized controlled trial involving 2 age categories of low-SES caregiver-child dyads served by the Reach Out and Read (ROR) program, each followed for 6 months. For each category, a baseline assessment (pre-) and an outcomes assessment (post-) will be conducted, to explore effects of "enhanced" ROR using the Rx for Success (RS) smartphone app. Category 1 will involve 6 month-old infants, followed until they are 12 months old. Category 2 will involve 18 month-old toddlers, followed until they are 24 months old. Recruitment, informed consent, behavioral testing and intervention will take place at a high-volume primary care clinic based in a major, urban academic medical center in Connecticut (Community Health Center, Inc. at Connecticut Children's Medical Center; CHC@CCMC). Providers in the clinical sites are trained in child development and the administration of ROR during well-child visits between birth and age 5, including those involved with our study at 6, 12, 18, and 24 months old.

Families assigned to the control arm in each age category will receive customary ROR, including the provision of an age-appropriate children's book, and reading-related developmental surveillance and anticipatory guidance. In addition, control families will receive a new children's book reinforcing AAP screen-based media recommendations. Families in the intervention arm in both age categories will receive "enhanced" ROR involving the provision of the Rx for Success (RS) application at the baseline visit (6 months old and 18 months old, respectively). No additional intervention will take place, other than push notifications and other content built into the RS application.

The investigators will recruit 248 children in our 2 age categories: approximately 6 months old (infants, n=124), and approximately 18 months old (toddlers, n=124) via convenience sampling in the CHC@CCMC clinic waiting room during regularly scheduled well-child visits. This study will be powered based on the primary language outcome measure (LENA Snapshot). For a two-group (intervention/control), pre-post repeated-measure analysis with two age categories (6-12 months, 18-24 months), an ANCOVA model will be applied for both age categories and their interaction, to assess the difference in language scores between intervention and control groups.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This is a prospective, randomized controlled trial involving 2 age categories of low-SES caregiver-child dyads served by the ROR program, each followed for 6 months. For each category, a baseline assessment (pre-) and an outcomes assessment (post-) will be conducted. Category 1 will involve 6 month-old infants, followed until they are 12 months old. Category 2 will involve 18 month-old toddlers, followed until they are 24 months old.

Families assigned to the control arm in each age category will receive customary ROR, and reading-related developmental surveillance and anticipatory guidance. Control families will also receive a new children's book reinforcing AAP screen-based media recommendations. Families in the intervention arm will receive "enhanced" ROR involving the provision of the Rx for Success (RS) application at the baseline visit (6 months old and 18 months old, respectively).

Masking: Single (Participant)
Masking Description:
Families enrolled in the study will be blinded to its specific aims, other than "We are looking at ways to make reading with children at home more fun and interactive."
Primary Purpose: Prevention
Condition  ICMJE
  • Literacy
  • Child Development
  • Parenting
Intervention  ICMJE
  • Other: Rx for Success Smartphone Application
    The Rx for Success (RS) mobile application (app) was developed by the non-profit, Children, Inc. The app is designed to be informational and motivational with both video and cueing content. The app uses a "View It, Cue It, Do It" model that allows parents to quickly download the smartphone app, view brief videos of age-indexed, research-based language enrichment practices; and regulate a push notification cueing program. Videos embedded in the RS app provide a summary of dialogic reading tailored for the child's age, and suggestions for encouraging verbal interactivity and social-emotional engagement through dialogic reading. Key behaviors reinforced by the app include discussing the story before reading to build interest and enthusiasm, followed by interactive reading modeled by specific types of verbal/behavioral prompts for the parent to make and responses to what the child says or does.
  • Other: Control - screen time reduction
    Control families will receive a new, specially designed children's book regarding limiting screen-based media use and encouraging healthy/active alternatives (Baby Unplugged: Play, Hutton/Jones, blue manatee press), which lists American Academy of Pediatrics screen time recommendations on the back cover.
Study Arms  ICMJE
  • Active Comparator: Control - screen time reduction
    Families assigned to the control arm in each age category will receive customary ROR, including the provision of an age-appropriate children's book, and reading-related developmental surveillance and anticipatory guidance. In addition, control families will receive a new children's book reinforcing AAP screen-based media recommendations.
    Intervention: Other: Control - screen time reduction
  • Experimental: Rx for Success Smartphone Application
    Families in the intervention arm in both age categories will receive "enhanced" ROR involving the provision of the Rx for Success (RS) application at the baseline visit (6 months old and 18 months old, respectively). No additional intervention will take place, other than "push" notifications and other content such as demonstration videos built into the RS application.
    Intervention: Other: Rx for Success Smartphone Application
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2020)
252
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2019)
248
Actual Study Completion Date  ICMJE July 1, 2019
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Gestation of at least 34 weeks,
  • Age at initial screening 6 months (5.75 months-7.5 months) or 18 months old (17-21 months).
  • No documented history of major neurological insult such as intracranial hemorrhage or V-P shunt.
  • Comfortable speaking English during their WCC and reviewing/comprehending study materials without a translator, including informed consent.
  • Functional literacy in at least one primary caregiver, defined as the ability to navigate the RS application, read prompts provided by the RS application (targeted 6th grade reading level as estimated via the Readable.io website), and understand/provide informed consent, administered in English.
  • Possession of a smartphone or tablet device capable of downloading, installing and utilizing the RS application.

Exclusion Criteria:

  • Not meeting inclusion criteria above
  • Twins
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 21 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03828721
Other Study ID Numbers  ICMJE 2017-6856
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Do not plan to share this data.
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor  ICMJE Children's Hospital Medical Center, Cincinnati
Collaborators  ICMJE
  • Reach Out and Read National Office
  • Connecticut Children's Medical Center
Investigators  ICMJE Not Provided
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP