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Communication Intervention for Toddlers With Hearing Loss

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ClinicalTrials.gov Identifier: NCT03803943
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Megan Roberts, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Hearing Loss, Bilateral Behavioral: Parent-Implemented Communication Intervention (PICT) Other: No Intervention - Business-as-usual control Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Masking Description: Outcome assessors and coders will be naive to experimental condition
Primary Purpose: Treatment
Official Title: Communication Intervention for Toddlers With Hearing Loss
Estimated Study Start Date : May 14, 2019
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Parent-Implemented Communication Intervention (PICT)
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)
Weekly hour long intervention sessions for 6 months
Other Name: PICT

Placebo Comparator: No Intervention - Business-as-usual control
Participants assigned to the BAU control group will not receive the PICT intervention.
Other: No Intervention - Business-as-usual control
Does not receive PICT internvention
Other Name: BAU




Primary Outcome Measures :
  1. Caregiver Use of Communication Support Strategies [ Time Frame: Change in monthly samples between pre and post when the child is 12 to 18 months (during intervention) ]
    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.

  2. Total number of pre-symbolic communicative acts from the Language Sample [ Time Frame: Change in monthly samples between pre and post when the child is 12 to 18 months (during intervention) ]
    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.

  3. Total Scaled Score on the Communication and Symbolic Behavior Scales - Developmental Profile [ Time Frame: Post (immediately after intervention when the child is 18 months) ]
    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 :
  1. Caregiver Use of Communication Support Strategies [ Time Frame: Monthly, up to 18 months, between post and follow-up when the child is 18 to 36 months (after intervention) ]
    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.

  2. Child Spoken Words [ Time Frame: Monthly, up to 18 months, between post and follow-up when the child is 18 to 36 months (after intervention) ]
    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.

  3. Expressive Communication Standard Score on the Preschool Language Scale - 5th Edition [ Time Frame: Follow up (18 months after the study start when child is 36 months) ]
    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.

  4. Auditory Comprehension Standard Score on the Preschool Language Scale - 5th Edition [ Time Frame: Follow up (18 months after the study start when child is 36 months) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Months to 14 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • have bilateral, congenital HL as measured by a review of medical records
  • enrollment in the study between 10 and 14 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803943


Contacts
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Contact: Megan Y Roberts, PhD 8474913183 ei@northwestern.edu
Contact: Laura J Sudec, MSW 8474913183 laura.sudec@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Evanston, Illinois, United States, 60208
Contact: Megan Y Roberts, PhD    847-491-3183    megan.y.roberts@northwestern.edu   
Contact: Laura Sudec, MSW    8474913183    laura.sudec@northwestern.edu   
Principal Investigator: Megan Y Roberts, PhD         
Sponsors and Collaborators
Northwestern University
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
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Principal Investigator: Megan Y Roberts, PhD Northwestern University

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Responsible Party: Megan Roberts, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT03803943     History of Changes
Other Study ID Numbers: 1R01DC016877-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Megan Roberts, Northwestern University:
Hearing Loss
Toddlers
Early Intervention
Parent-mediated intervention

Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Bilateral
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms