LiteracyNCT03828721
Rx for Success: RCT of an App for Dialogic Reading Training
A study testing Rx for Success Smartphone Application in people with Literacy and Child Development, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 21 monthsHealthy volunteers can take part
- Conditions the study is for
- Literacy, Child Development, Parenting
- What is being tested?
- Rx for Success Smartphone Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2018to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 21 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Not meeting inclusion criteria above
- Twins
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Health Center@ Connecticut Children's Medical Center
Hartford, Connecticut, 06106
About this study
Official title: Rx for Success: A Randomized Controlled Trial of Technology-Based Dialogic Reading Training
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:
Read more
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).
Read the 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.
- Conditions
- Literacy, Child Development, Parenting
- Being tested
- Rx for Success Smartphone Application, Control - screen time reduction
- Medical subject headings
- Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rx for Success Smartphone ApplicationOther
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.
Control - screen time reductionOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Rx for Success Smartphone Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Language
Comparison of scores on the LENA Snapshot parent report measure before and after DR intervention between intervention and control groups.
Measured: 6 months
Social-emotional
Comparison of scores on items exerpted from the DECA-I/T Measure, attachment sub scale between intervention and control groups.
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
Screen-based media use
Comparison of ScreenQ scores (screen-based media use at home) between intervention and control groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start20 Mar 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LiteracyStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Reach Out and Read National Office, Connecticut Children's Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828721
- Sponsor's protocol ID
- 2017-6856
- Status last verified
- Jan 2019
- First submitted
- 5 Mar 2018
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Do not plan to share this data.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rx for Success: A Randomized Controlled Trial of Technology-Based Dialogic Reading Training
- ClinicalTrials.gov ID
- NCT03828721
- Acronym / sponsor ID
- 2017-6856
- Conditions
- Literacy, Child Development, Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Reach Out and Read National Office, Connecticut Children's Medical Center
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Control - screen time reduction | Active comparator | Other: Control - screen time reductionFamilies 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. |
| Rx for Success Smartphone Application | Experimental | Other: Rx for Success Smartphone ApplicationFamilies 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. |
Who may qualify
- Ages
- 6 to 21 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Not meeting inclusion criteria above
- Twins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rx for Success Smartphone ApplicationThe 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 | Rx for Success Smartphone Application |
| Control - screen time reductionControl 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. | Other | Control - screen time reduction |
Primary outcome
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.
1 secondary outcome
Screen-based media use
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: No. Do not plan to share this data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rx for Success Smartphone Application in people with Literacy and Child Development, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Language (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.