Improving Print Knowledge for Children With Hearing Loss
Primary Purpose
Hearing Loss
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sit Together and REad
Sponsored by
About this trial
This is an interventional prevention trial for Hearing Loss
Eligibility Criteria
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:
-
Sites / Locations
- Nationwide Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
STAR - immediate
STAR - waitlist control
Arm Description
Receive 15-week STAR intervention immediately after pretest.
No intervention for the 15 weeks after pretest.
Outcomes
Primary Outcome Measures
STAR Log
Document intensity, defined as occurrence and length of each session and targeted goals within each.
STAR Fidelity Coding Checklist (FCC)
Document dosage, defined as the volume of explicit targeting of print-related objectives during STAR sessions.
Preschool Word and Print Awareness (PWPA)
Examines knowledge of 15 print concepts. Scores on this scale range from 0-17, with higher scores indicative of better performance.
Phonological Awareness Literacy Screening-PreK (PALS-PreK)
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.
Test of Preschool Emergent Literacy (TOPEL)
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04027881
Brief Title
Improving Print Knowledge for Children With Hearing Loss
Official Title
Improving Print Knowledge for Children With Hearing Loss
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This R56 award will address questions pertaining to the feasibility of the Sit Together and Read (STAR) intervention for children with hearing loss (HL). Evidence suggests that STAR, a caregiver-implemented early literacy intervention, imparts positive effects on print knowledge gains and later reading outcomes for children at risk for reading difficulties, such as those with language impairment and those living in poverty. To date there are no large-scale studies examining literacy interventions for children with HL, who are also known to be at risk for reading disorders. However, prior to engaging in a large-scale study, this research will establish preliminary feasibility and efficacy data for this specific population who will likely benefit from a evidence-based, manualized intervention. In addition to collecting pilot data regarding the feasibility and efficacy of this intervention for children with HL, this study will also determine barriers and challenges experienced by caregivers of children with HL in implementing the intervention. As such, this study will also yield important information regarding adaptations of the existing STAR intervention that may be required for successful and effective implementation for children with HL, and can be incorporated into future submissions.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to start the intervention immediately after baseline assessment (i.e., treatment) or approximately 15 weeks later after the baseline assessment (i.e., waitlist control).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
STAR - immediate
Arm Type
Experimental
Arm Description
Receive 15-week STAR intervention immediately after pretest.
Arm Title
STAR - waitlist control
Arm Type
No Intervention
Arm Description
No intervention for the 15 weeks after pretest.
Intervention Type
Behavioral
Intervention Name(s)
Sit Together and REad
Other Intervention Name(s)
STAR
Intervention Description
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.
Primary Outcome Measure Information:
Title
STAR Log
Description
Document intensity, defined as occurrence and length of each session and targeted goals within each.
Time Frame
15-week intervention period
Title
STAR Fidelity Coding Checklist (FCC)
Description
Document dosage, defined as the volume of explicit targeting of print-related objectives during STAR sessions.
Time Frame
15-week intervention period
Title
Preschool Word and Print Awareness (PWPA)
Description
Examines knowledge of 15 print concepts. Scores on this scale range from 0-17, with higher scores indicative of better performance.
Time Frame
15-week intervention period
Title
Phonological Awareness Literacy Screening-PreK (PALS-PreK)
Description
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.
Time Frame
15-week intervention period
Title
Test of Preschool Emergent Literacy (TOPEL)
Description
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
Time Frame
15-week intervention period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherine Tambyraja, PhD
Phone
614-292-8384
Ext
3474157615
Email
tambyraja.1@osu.edu
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ursula Findlen, PhD
Phone
614-722-2000
Email
ursula.findlen@nationwidechildrens.org
First Name & Middle Initial & Last Name & Degree
Ursula Findlen, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Improving Print Knowledge for Children With Hearing Loss
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