Improving Print Knowledge for Children With Hearing Loss

NCT04027881 | Completed

• 1 other identifier: tambyraja.1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (5)

• STAR Log

  Document intensity, defined as occurrence and length of each session and targeted goals within each.

  15-week intervention period

• STAR Fidelity Coding Checklist (FCC)

  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)

  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)

  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)

  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

Study Arms (2)

STAR - immediate

EXPERIMENTAL

Receive 15-week STAR intervention immediately after pretest.

Behavioral: Sit Together and REad

STAR - waitlist control

NO INTERVENTION

No intervention for the 15 weeks after pretest.

Interventions

Sit Together and REad BEHAVIORAL

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.

Also known as: STAR

STAR - immediate

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Caregiver willing to attend in-person meetings
• Caregiver willing to read regularly to the child in English for 15 consecutive weeks

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 22, 2019
• Study Start: January 10, 2020
• Primary Completion: May 20, 2021
• Study Completion: September 25, 2021
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)