Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Hearing Loss
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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

Participation Requirements

Age
Between 4 years and 125 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT04027881
Collaborators
Not Provided
Investigators
Not Provided