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

NCT03828721 | Completed

• 1 other identifier: 2017-6856
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

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).

Conditions

Literacy; Child Development; Parenting

Outcome Measures

Primary Outcomes (3)

• Language

  Comparison of scores on the LENA Snapshot parent report measure before and after DR intervention between intervention and control groups.

  6 months

• Social-emotional

  Comparison of scores on items exerpted from the DECA-I/T Measure, attachment sub scale between intervention and control groups.

  6 months

• Home reading behaviors

  Comparison of scores on items exerpted from the StimQ-I/T and DialogPR-IT measures between intervention and control groups.

  6 months

Secondary Outcomes (1)

• Screen-based media use

  6 months

Study Arms (2)

Control - screen time reduction

ACTIVE COMPARATOR

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

Rx for Success Smartphone Application

EXPERIMENTAL

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

Interventions

Rx for Success Smartphone Application OTHER

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.

Rx for Success Smartphone Application

Control - screen time reduction OTHER

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.

Control - screen time reduction

Eligibility Criteria

• Age: 6 Months - 21 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Twins

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Reach Out and Read National Office: collaborator
• Connecticut Children's Medical Center: collaborator

Study Sites (1)

Community Health Center@ Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

Communication; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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."
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: February 4, 2019
• Study Start: March 20, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: June 16, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)