Early Communication Intervention for Toddlers With Hearing Loss

NCT03803943 | Completed Phase 2 Results

• 1 other identifier: 1R01DC016877-01A1
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Improving spoken language outcomes for children with hearing loss has important public health implications. This is a randomized clinical trial of 96 children with hearing loss that examines the effects of a parent-implemented early communication intervention on prelinguistic and spoken language outcomes. The study is open for national recruitment. Parents participate via video call with their child and receive technology to assist with virtual visits.

Conditions

Hearing Loss, Bilateral

Keywords

Hearing Loss; Toddlers; Early Intervention; Parent-mediated intervention

Outcome Measures

Primary Outcomes (3)

• Use of Communication Support Strategies - Parent

  Parent use of communication support strategies was measured from a 12-minute parent-child interaction in which the dyad plays using a standard set of toys. Interactions were video recorded and coded for 13 items representing subcomponents of seven communication support strategies. Each item was rated on a 5-point scale (1 = novice use, 5 = expert use), reflecting the quality and proficiency of parent strategy use. Items were averaged to yield a Total Composite Score (Min = 1, Max = 5), with higher scores indicating more proficient and consistent use of communication strategies.

  Change from Baseline to Month 7

• Total Number of Communicative Acts From the Language Sample - Child

  During the 10-minute interaction, the child played with toys and wordless picture books. A research assistant transcribed and coded all communicative acts. Each communicative act was assigned a weight reflecting its developmental complexity: gestures and vocalizations = 1 point, single words = 2 points, and multiple-word utterances = 3 points. The Total Weighted Frequency Score (Min = 0, Max = NA) is the sum of the weighted frequency of each act, with higher scores reflecting more frequent and complex communicative acts.

  Change from Baseline to Month 7

• Communication and Symbolic Behavior Scales Score - Child

  The child is presented with 6 different activities (wind-up toy, balloon, bubbles, jar, books, play) designed to elicit child communication. The interaction is video recorded and then scored for 20 items across 7 communication scales (emotion and eye gaze, communication, gestures, sounds, words, understanding, and object use). The weighted raw scores for each of the 7 scales were grouped into 3 clusters (social, speech, and symbolic) and combined into a total raw score (min = 0; max = 113). Higher scores indicate better skills.

  Month 7

Secondary Outcomes (4)

• Use of Communication Support Strategies - Parent

  Change from Baseline to Month 24

• Spoken Words - Child

  Change from Baseline to Month 24

• Expressive Communication Standard Score on the Preschool Language Scale - 5th Edition - Child

  Month 24

• Auditory Comprehension Standard Score on the Preschool Language Scale - 5th Edition - Child

  Month 24

Study Arms (2)

Parent-Implemented Communication Intervention (PICT)

EXPERIMENTAL

Participants assigned to the PICT condition will receive weekly hour long intervention sessions in their home for 6 months. Parents will learn four sets of communication support strategies: (a) visual (e.g., modeling language within the child's line of sight), (b) interactive (e.g., following the child's attentional focus), (c) responsive (e.g., responding to all communicative attempts), and (d) linguistically stimulating (e.g., modeling language targets, expanding child communication).

Behavioral: Parent-Implemented Communication Intervention (PICT)

No Intervention - Business-as-usual control

PLACEBO COMPARATOR

Participants assigned to the BAU control group will not receive the PICT intervention.

Other: No Intervention - Business-as-usual control

Interventions

Parent-Implemented Communication Intervention (PICT) BEHAVIORAL

Weekly hour long intervention sessions for 6 months

Also known as: PICT

Parent-Implemented Communication Intervention (PICT)

No Intervention - Business-as-usual control OTHER

Does not receive PICT intervention

Also known as: BAU

No Intervention - Business-as-usual control

Eligibility Criteria

• Age: 12 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• have bilateral, congenital HL as measured by a review of medical records
• enrollment in the study between 12 and 18 months of age
• have no known additional disabilities (e.g., Down syndrome, cerebral palsy, seizure disorder, blindness, etc.) as measured by review of medical records and parent report
• have English as the primary language spoken at home
• have one parent with normal hearing, and (f) are exposed to some degree of spoken language by their parents (total communication, auditory/oral)

Sponsors & Collaborators

• Northwestern University: lead
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator

Study Sites (1)

Northwestern University

Evanston, Illinois, 60208, United States

Location

MeSH Terms

Conditions

Hearing Loss, Bilateral; 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

Results Point of Contact

• Title: Megan Roberts
• Organization: Northwestern University

megan.y.roberts@northwestern.edu

(847) 491-3066

Study Officials

• Megan Y Roberts, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and coders will be naive to experimental condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Children will enroll in the study around 12 months of age and will be randomly assigned to either a parent-implemented communication intervention (PICT) or a control group.

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 15, 2019
• Study Start: June 15, 2019
• Primary Completion: May 16, 2023
• Study Completion: October 10, 2024
• Last Updated: October 15, 2025
• Results First Posted: October 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Transcripts from caregiver-child and examiner-child language samples will also be donated to the Child Language Data Exchange System (http://childes.psy.cmu.edu), an international repository of child language data. Access to the data will be openly available. Researchers who access the transcripts will be expected to abide by the established guidelines for use of TalkBank data http://talkbank.org/share/irb/options.html.

Locations

US (1)