- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04027881
Improving Print Knowledge for Children With Hearing Loss
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will use a randomized (1:1) waitlist controlled trial design to test the effects of a 15-week caregiver-implemented STAR intervention for children with HL. STAR incorporates a high intensity of home-based shared book reading sessions (i.e., 4 times a week) in which caregivers embed guided discussions about foundational reading concepts that are prerequisites for learning to read. Caregivers will receive individualized training and materials for implementing STAR at home with their child. Caregivers will be provided with materials and equipment to read and audio record their readings 4 times a week, and to engage in meaningful, instructional dialogue while reading, in order to help children learn about foundational reading topics, such as letter names and sounds.
The study is guided by the following specific aims: Aim 1: Determine the extent to which caregivers of children with HL can effectively implement a home-based reading intervention for their children. Hypothesis 1: Caregivers will effectively implement the STAR intervention but there will be some variability. Aim 2: Improve the early literacy skills of children with HL, by implementing STAR. Hypothesis 2: Children whose caregivers are randomized to the home-implemented STAR intervention will demonstrate significantly greater gains in early reading skills over the implementation period, compared to those randomized to a waitlist control condition. Aim 3: Identify implementation barriers or challenges experienced by caregivers of children with HL. This aim is exploratory and will inform potential adaptations to the intervention that may be required for future, more successful intervention implementation by caregivers of children with HL.
Upon completion, the investigators will have established the feasibility and effectiveness of the STAR intervention for children with HL and their caregivers. Data from this study will be the foundation for a large-scale randomized-controlled clinical trial that focuses on improving the reading outcomes of children with a range of communication disorders and identifying optimal methods for supporting their caregivers.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sherine Tambyraja, PhD
- Phone Number: 3474157615 614-292-8384
- Email: tambyraja.1@osu.edu
Study Locations
-
-
Ohio
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Columbus, Ohio, United States, 43205
- Recruiting
- Nationwide Children's Hospital
-
Contact:
- Ursula Findlen, PhD
- Phone Number: 614-722-2000
- Email: ursula.findlen@nationwidechildrens.org
-
Sub-Investigator:
- Ursula Findlen, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for children:
- Child 4 years, 0 months to 5 years, 11 months at enrollment
- Child has bilateral sensorineural hearing loss
- child has at least one years' experience of hearing device use (hearing aid, cochlear implant)
- child does not have a severe cognitive disability
Inclusion Criteria for caregivers:
- Caregiver willing to attend in-person meetings
- Caregiver willing to read regularly to the child in English for 15 consecutive weeks
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: STAR - immediate
Receive 15-week STAR intervention immediately after pretest.
|
STAR is an evidence-based home-based shared book reading intervention designed to improve the foundational reading skills of preschoolers who are at risk for reading disabilities.
Other Names:
|
NO_INTERVENTION: STAR - waitlist control
No intervention for the 15 weeks after pretest.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
STAR Log
Time Frame: 15-week intervention period
|
Document intensity, defined as occurrence and length of each session and targeted goals within each.
|
15-week intervention period
|
STAR Fidelity Coding Checklist (FCC)
Time Frame: 15-week intervention period
|
Document dosage, defined as the volume of explicit targeting of print-related objectives during STAR sessions.
|
15-week intervention period
|
Preschool Word and Print Awareness (PWPA)
Time Frame: 15-week intervention period
|
Examines knowledge of 15 print concepts.
Scores on this scale range from 0-17, with higher scores indicative of better performance.
|
15-week intervention period
|
Phonological Awareness Literacy Screening-PreK (PALS-PreK)
Time Frame: 15-week intervention period
|
Upper and Lower Case Letter Knowledge subtests will identify the number of letters children can name.
The range on these subtests is 0-26, with higher scores indicative of better performance.
The name writing subtest will assess children's ability to write their own name.
The range on this subtest is 0-7, with higher scores indicative of better performance.
|
15-week intervention period
|
Test of Preschool Emergent Literacy (TOPEL)
Time Frame: 15-week intervention period
|
The print knowledge subtest will be used to assess children's skills on a variety of print-related tasks, such as distinguishing print from other visual stimuli and identifying alphabet letters.
Raw scores on this subtest range from 0-36, with higher scores indicative of better performance
|
15-week intervention period
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- tambyraja.1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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