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Early Communication Intervention for Toddlers With Hearing Loss

Primary Purpose

Hearing Loss, Bilateral

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Parent-Implemented Communication Intervention (PICT)
No Intervention - Business-as-usual control
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Bilateral focused on measuring Hearing Loss, Toddlers, Early Intervention, Parent-mediated intervention

Eligibility Criteria

12 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Parent-Implemented Communication Intervention (PICT)

No Intervention - Business-as-usual control

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
January 8, 2019
Last Updated
March 21, 2023
Sponsor
Northwestern University
Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT03803943
Brief Title
Early Communication Intervention for Toddlers With Hearing Loss
Official Title
Early Communication Intervention for Toddlers With Hearing Loss
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2019 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Bilateral
Keywords
Hearing Loss, Toddlers, Early Intervention, Parent-mediated intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
Outcome assessors and coders will be naive to experimental condition
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parent-Implemented Communication Intervention (PICT)
Arm Type
Experimental
Arm Description
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).
Arm Title
No Intervention - Business-as-usual control
Arm Type
Placebo Comparator
Arm Description
Participants assigned to the BAU control group will not receive the PICT intervention.
Intervention Type
Behavioral
Intervention Name(s)
Parent-Implemented Communication Intervention (PICT)
Other Intervention Name(s)
PICT
Intervention Description
Weekly hour long intervention sessions for 6 months
Intervention Type
Other
Intervention Name(s)
No Intervention - Business-as-usual control
Other Intervention Name(s)
BAU
Intervention Description
Does not receive PICT internvention
Primary Outcome Measure Information:
Title
Caregiver Use of Communication Support Strategies
Description
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.
Time Frame
Change in monthly samples between pre and post when the child is 12 to 18 months (during intervention)
Title
Total number of pre-symbolic communicative acts from the Language Sample
Description
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.
Time Frame
Change in monthly samples between pre and post when the child is 12 to 18 months (during intervention)
Title
Total Scaled Score on the Communication and Symbolic Behavior Scales - Developmental Profile
Description
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.
Time Frame
Post (immediately after intervention when the child is 18 months)
Secondary Outcome Measure Information:
Title
Caregiver Use of Communication Support Strategies
Description
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.
Time Frame
Monthly, up to 18 months, between post and follow-up when the child is 18 to 36 months (after intervention)
Title
Child Spoken Words
Description
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.
Time Frame
Monthly, up to 18 months, between post and follow-up when the child is 18 to 36 months (after intervention)
Title
Expressive Communication Standard Score on the Preschool Language Scale - 5th Edition
Description
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.
Time Frame
Follow up (18 months after the study start when child is 36 months)
Title
Auditory Comprehension Standard Score on the Preschool Language Scale - 5th Edition
Description
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.
Time Frame
Follow up (18 months after the study start when child is 36 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Y Roberts, PhD
Phone
8474913183
Email
ei@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Laura J Sudec, MSW
Phone
8474913183
Email
laura.sudec@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Y Roberts, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Y Roberts, PhD
Phone
847-491-3183
Email
megan.y.roberts@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Laura Sudec, MSW
Phone
8474913183
Email
laura.sudec@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Megan Y Roberts, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data and associated documentation available to users only under a data-sharing agreement that provides for a commitment: (1) to use the data only for research purposes and not to identify any individual participant; (2) to secure the data using appropriate computer technology; (3) to destroy or return the data after analyses are completed; and (4) to cite the grant and key publications describing the database and measures in any resulting presentations and publications.
IPD Sharing 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.

Learn more about this trial

Early Communication Intervention for Toddlers With Hearing Loss

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