Teletherapy in Children Who Are Deaf and Hard of Hearing

NCT04928209 | Completed DMC

• 1 other identifier: AD-2020C1-19403
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 5

Brief Summary

This study seeks to determine the effectiveness of speech/language teletherapy to address disparities in speech and language outcomes in children who are deaf or hard-of-hearing (D/HH). The investigators will enroll D/HH children aged 0-27 months. 140 children who are publicly insured will be randomized to receive usual clinical care or to be given access to an 18-month course of speech-language teletherapy program. 70 children who are privately insured will also be enrolled and will receive usual care. Children will undergo, at baseline and every 9 months thereafter to a study endpoint of 18 months, for a total of 3 timepoints, a battery of in-person and parent-report assessments designed to provide a comprehensive measurement of the child's auditory function, speech, verbal- and non-verbal communication, spoken language, and quality of life.

Conditions

Hearing Loss; Speech and Language Development Delay Due to Hearing Loss

Keywords

Hearing Loss; Hearing Loss in Children; Congenital Hearing Loss; Speech-Language Teletherapy

Outcome Measures

Primary Outcomes (1)

• PLS-5 Auditory Comprehension (AC) Standard Score - 18 month

  The PLS-5 is a standard developmental language assessment that measures communication skills in children ages birth to 7 years. Score to report: standard score.

  18 months

Secondary Outcomes (53)

• PLS-5 Auditory Comprehension (AC) Standard Score - 9 month

  9 month

• PLS-5 Auditory Comprehension (AC) Standard Score - 9 month change

  9 month, change from baseline

• PLS-5 Auditory Comprehension (AC) Standard Score - 18 month change

  18 month, change from baseline

• PLS-5 Expressive Communication (EC) Standard Score - 9 month

  9 month

• PLS-5 Expressive Communication (EC) Standard Score - 18 month

  18 month

Study Arms (3)

Usual Care (High-Income)

NO INTERVENTION

This group will receive comprehensive assessments every 9 months for the 18-month period of enrollment, for a total of 3 assessments. They will not be randomized to receive supplemental teletherapy (intervention) and usual care.

Usual Care (Low-Income)

NO INTERVENTION

This group includes the low-income families who satisfy the criteria to receive supplemental speech-language teletherapy but are not randomized to receive the intervention after allocation. Like the "Usual Care (High-Income) arm, they will only receive comprehensive assessments every 9 months for the 18-month period of enrollment, for a total of 3 assessments and usual care.

Usual Care + Teletherapy (Low-Income)

EXPERIMENTAL

This group includes the low-income families who satisfy the criteria to receive supplemental speech-language teletherapy and are randomized to receive the intervention. They will receive both 3x comprehensive assessments every 9 months AND access to supplemental speech-language teletherapy for the 18-month study period.

Other: Speech-Language Teletherapy

Interventions

Speech-Language Teletherapy OTHER

Access to speech-language teletherapy will be provided as a supplement to Usual Care for subjects randomized to this group. Access is provided by way of 1) direct referral by the clinical team to a teletherapist; 2) availability of a teletherapy slot. All teletherapy providers will be licensed speech-language pathologists (SLPs) and/or credentialed teachers of the deaf (TODs) with specialized training to work with children who are D/HH using an LSL approach. Fluent English and Spanish speaking providers will be matched to the child's home, native language. Teletherapy itself is within routine clinical care and is not considered a research activity. Children who randomize to the Low TT study arm will receive access to an 18-month course of weekly teletherapy, in accordance with the centers' standard of care. The exact details of the therapy course and frequency will be determined based on individual family needs.

Usual Care + Teletherapy (Low-Income)

Eligibility Criteria

• Age: 0 Months - 27 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 0-27 months;
• Hearing loss, as determined by auditory brainstem response (ABR) or behavioral audiometry (average of pure-tone air-conduction hearing thresholds (0.5-4 kHz; PTA) calculated from at least 2 frequencies from ABR (dB eHL) or behavioral audiometry (dB HL)):
• bilateral sensorineural, mixed, or permanent conductive hearing loss with better-ear PTA \> 20 dB.
• single-sided deafness (unilateral SNHL with PTA \> 70 dB);
• unilateral complete aural atresia; or
• bilateral auditory-neuropathy spectrum disorder, as determined by ABR.
• Primary home language is English or Spanish, determined by electronic medical record or direct parent report.
• For children with PTA \> 20 dB, either:
• Currently fit with hearing aid or using a cochlear implant; OR
• Date identified for hearing-aid fitting or cochlear-implant activation within 3 months of enrollment.

You may not qualify if:

• Family does NOT have the intention to pursue listening and spoken language for their child, based on parent report;
• Moderate to severe global developmental delay, as determined by managing audiologist and/or otolaryngologist, based on:
• ICD-10 diagnosis code or chart review of medical progress notes indicating global developmental delay;
• presence of syndrome known to be associated with this delay (such as Trisomy 21, 22q11 syndrome, or CHARGE syndrome); OR
• parent report.
• Speech-language teletherapy received through a clinical provider outside of this study at the time of enrollment, based on parent report.
• No prognosis for access to sound as determined by managing audiologist and/or otolaryngologist. All children with bilateral severe-to-profound SNHL must have imaging to confirm this criterion prior to enrollment in the study. Children will be excluded if they have bilateral severe-to-profound sensorineural hearing loss and either:
• Contraindication to cochlear implantation, OR
• Temporal bone abnormalities that lead to great concern for poor cochlear-implant outcomes, including common cavity and/or cochlear nerve deficiency on imaging.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (5)

UCSF Benioff Children's Hospital - Oakland

Oakland, California, 94609, United States

Location

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94303, United States

Location

Rady Children's Hospital - San Diego

San Diego, California, 92123, United States

Location

The University of California - San Francisco

San Francisco, California, 94158, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98145, United States

Location

Related Publications (2)

• VanderWeele TJ. A three-way decomposition of a total effect into direct, indirect, and interactive effects. Epidemiology. 2013 Mar;24(2):224-32. doi: 10.1097/EDE.0b013e318281a64e.

  PMID: 23354283 BACKGROUND

• Naugle K, Stephans J, Lazar A, Kearns JM, Coulthurst S, Tebb KP, Chan DK. Teletherapy to address language disparities in deaf and hard-of-hearing children: study protocol for an inclusive multicentre clinical trial. BMJ Open. 2024 Aug 8;14(8):e089118. doi: 10.1136/bmjopen-2024-089118.

  PMID: 39122403 DERIVED

MeSH Terms

Conditions

Hearing Loss; Speech

Condition Hierarchy (Ancestors)

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

Study Officials

• Dylan K Chan, MD, PhD

  The University of California - San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 16, 2021
• Study Start: July 15, 2021
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)