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出境医 / 临床实验 / Improving Print Knowledge for Children With Hearing Loss

Improving Print Knowledge for Children With Hearing Loss

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.

Condition or disease Intervention/treatment Phase
Hearing Loss Behavioral: Sit Together and REad Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Improving Print Knowledge for Children With Hearing Loss
Actual Study Start Date : January 10, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : September 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: STAR - immediate
Receive 15-week STAR intervention immediately after pretest.
 Behavioral: Sit Together and REad
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 Name: STAR
No Intervention: STAR - waitlist control
No intervention for the 15 weeks after pretest.
Outcome Measures
Primary Outcome Measures :
  1. STAR Log [ Time Frame: 15-week intervention period ]
    Document intensity, defined as occurrence and length of each session and targeted goals within each.

  2. 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.

  3. 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.

  4. 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.

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

-

Contacts and Locations

Contacts
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Contact: Sherine Tambyraja, PhD 614-292-8384 ext 3474157615 tambyraja.1@osu.edu

Locations
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United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Ursula Findlen, PhD    614-722-2000    ursula.findlen@nationwidechildrens.org   
Sub-Investigator: Ursula Findlen, PhD         
Sponsors and Collaborators
Ohio State University
Tracking Information
First Submitted Date  ICMJE June 28, 2019
First Posted Date  ICMJE July 22, 2019
Last Update Posted Date March 3, 2021
Actual Study Start Date  ICMJE January 10, 2020
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2019)
  • STAR Log [ Time Frame: 15-week intervention period ]
    Document intensity, defined as occurrence and length of each session and targeted goals within each.
  • 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.
  • 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.
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Print Knowledge for Children With Hearing Loss
Official Title  ICMJE Improving Print Knowledge for Children With Hearing Loss
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Condition  ICMJE Hearing Loss
Intervention  ICMJE Behavioral: Sit Together and REad
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 Name: STAR
Study Arms  ICMJE
  • Experimental: STAR - immediate
    Receive 15-week STAR intervention immediately after pretest.
    Intervention: Behavioral: Sit Together and REad
  • No Intervention: STAR - waitlist control
    No intervention for the 15 weeks after pretest.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 19, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sherine Tambyraja, PhD 614-292-8384 ext 3474157615 tambyraja.1@osu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04027881
Other Study ID Numbers  ICMJE tambyraja.1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ohio State University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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