Early Communication Intervention for Toddlers With Hearing Loss

Hearing Loss, Bilateral Clinical Trial

Official title:

Early Communication Intervention for Toddlers With Hearing Loss

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03803943
• Other study ID #: 1R01DC016877-01A1
• Status: Recruiting
• Phase: Phase 2
• Start date: June 15, 2019
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: Megan Y Roberts, PhD
• Phone: 8474913183
• Email: ei[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

While children with hearing loss (HL) are experiencing greater gains in spoken language than ever before, considerable variability exists and many children with HL continue to have poorer language skills than their hearing peers. Critical to reducing this variability is the identification of: (a) effective early communication interventions for children with HL and (b) child and parent characteristics that influence intervention outcomes (moderators and mediators). However, to date, only the pilot study for this proposed study has directly examined the effects of an early communication intervention for children with HL within the context of a randomized clinical trial. The overarching goals of the proposed study are to: (a) evaluate the effects of teaching parents to use communication support strategies on child communication outcomes and (b) examine parent and child characteristics that moderate and mediate intervention outcomes. The central hypothesis is that systematic parent training will result in greater parental use of communication support strategies, greater child pre-symbolic communicative acts, and greater child spoken language outcomes. The specific aims include: (a) comparing parent use of communication support strategies and child pre-symbolic communicative acts between intervention and control groups during and immediately following intervention (from 12 to 18 months of age), (b) examining parent (identification of child communication) and child (sensitivity to social contingency; attention to speech) moderators of intervention outcomes; (c) comparing parent use of communication support strategies and child spoken language outcomes between intervention and control groups after intervention (from 18 and 36 months of age); and (d) examining parent (use of communication support strategies) and child (pre-symbolic communicative acts) mediators of intervention outcomes. The proposed study will enroll 96 children with mild to profound bilateral hearing loss. 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. Children in both groups will be assessed: (a) at 12 months of age (immediately before intervention), (b) at 18 months of age (immediately after intervention), and (c) at 36 months of age (18 months after the end of intervention). Children in the intervention group will receive weekly, 1-hour intervention sessions for 6-months that: (a) are delivered during an important prelinguistic period of language development, (b) incorporate visual, interactive, responsive, and linguistically stimulating communication support strategies that are associated with stronger language skills in children with HL, and (c) include systematic parent training found to be effective in teaching parents to use communication support skills in children with language delays. The proposed research is significant because effective early communication intervention is likely to reduce persistent language delays in children with HL, thereby advancing the field of childhood hearing loss, where there is a striking paucity of rigorous communication intervention research.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: February 28, 2025
• Est. primary completion date: November 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 18 Months

Eligibility

Inclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Bilateral

Intervention

Behavioral:
• Parent-Implemented Communication Intervention (PICT)
Weekly hour long intervention sessions for 6 months

Other:
• No Intervention - Business-as-usual control
Does not receive PICT internvention

Locations

Country	Name	City	State
United States	Northwestern University	Evanston	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caregiver Use of Communication Support Strategies	Caregiver use of communication support strategies is measured from a 10-minute caregiver-child interaction in which the dyad plays using a standard set of toys. This interaction will be video recorded and coded for their use of communication support strategies to yield the following variables: percentage of adult communication that is within the child's line of sight, percentage of adult communication that is paired with a gesture in the child's line of sight, percentage of child communication that is followed by a contingent response, percentage of adult communication that is in response to child communication, percentage of adult communication that contains a child linguistic target, and percentage of child communication to which the adult imitates and adds a word. These variables will be combined using confirmatory factor analysis to create a single latent variable.	Change in monthly samples between pre and post when the child is 12 to 18 months (during intervention)
Primary	Total number of pre-symbolic communicative acts from the Language Sample	The child plays with four different sets of toys and looks at a wordless picture book for 20 minutes, while the assessor engages with the child but does not talk. Then a research assistant transcribes and codes all child communicative behavior.	Change in monthly samples between pre and post when the child is 12 to 18 months (during intervention)
Primary	Total Scaled Score on the Communication and Symbolic Behavior Scales - Developmental Profile	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). An overall total scaled score is calculated based on the raw score and the child's age (min = 65; max = 135). Higher scores indicate better skills.	Post (immediately after intervention when the child is 18 months)
Secondary	Caregiver Use of Communication Support Strategies	Caregiver use of communication support strategies will be measured from a 10-minute caregiver-child interaction in which the caregiver plays with the child using a standard set of toys. This interaction will be coded for their use of communication support strategies to yield the following variables: percentage of intervals in which the adult is communicating within the child's line of sight, percentage of adult communication that is paired with a gesture in the child's line of sight, percentage of intervals in which the adult's play is related to the child, percentage of child non-verbal actions that are imitated, percentage of child communication that is followed by a contingent response, percentage of adult communication that is in response to child communication, percentage of adult communication that contains a child linguistic target, percentage of child communication to which the adult imitates and adds a word. These variables will be combined to create a single latent variable.	Monthly, up to 18 months, between post and follow-up when the child is 18 to 36 months (after intervention)
Secondary	Child Spoken Words	Total number of spoken words will be collected using two measures that will be combined used confirmatory factory analysis. Total Number of Words Said from the MacArthur-Bates Communicative Development Inventory: Words and Sentences and the total number of different spoken word roots from a 20-minute language sample in which an assessor plays with the child following a standardized protocol.	Monthly, up to 18 months, between post and follow-up when the child is 18 to 36 months (after intervention)
Secondary	Expressive Communication Standard Score on the Preschool Language Scale - 5th Edition	The child is presented with different receptive tasks, such as following simple directions and pointing to pictures, until the child provides an incorrect response to six consecutive items. A total standard score is calculated based on the raw score and the child's age (min = 50; max = 150). Higher score indicate better outcomes.	Follow up (18 months after the study start when child is 36 months)
Secondary	Auditory Comprehension Standard Score on the Preschool Language Scale - 5th Edition	The child is presented with different expressive tasks, such as labeling pictures, until the child provides an incorrect response to six consecutive items. A total standard score is calculated based on the raw score and the child's age (min = 50; max = 150). Higher Scores indicate better outcomes.	Follow up (18 months after the study start when child is 36 months)