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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

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).


Condition or disease Intervention/treatment Phase
Literacy Child Development Parenting Other: Rx for Success Smartphone Application Other: Control - screen time reduction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
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
Official Title: Rx for Success: A Randomized Controlled Trial of Technology-Based Dialogic Reading Training
Actual Study Start Date : March 20, 2018
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Screen-based media use [ Time Frame: 6 months ]
    Comparison of ScreenQ scores (screen-based media use at home) between intervention and control groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 21 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828721


Locations
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United States, Connecticut
Community Health Center@ Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Reach Out and Read National Office
Connecticut Children's Medical Center
  Study Documents (Full-Text)

Documents provided by Children's Hospital Medical Center, Cincinnati:
Study Protocol  [PDF] February 12, 2018

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03828721    
Other Study ID Numbers: 2017-6856
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Do not plan to share this data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No