Early Communication Intervention for Toddlers With Hearing Loss

• ClinicalTrials.gov Identifier: NCT03803943
• Recruitment Status: Recruiting
• First Posted: January 15, 2019
• Last Update Posted: March 1, 2021
• Sponsor: Northwestern University
• Collaborator: Ann & Robert H Lurie Children's Hospital of Chicago
• Information provided by (Responsible Party): Megan Roberts, Northwestern University

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.

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.

Study Design

• 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: Early Communication Intervention for Toddlers With Hearing Loss
• Actual Study Start Date: June 15, 2019
• Estimated Primary Completion Date: February 28, 2024
• Estimated Study Completion Date: February 28, 2024

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 12 Months to 18 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 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)

Contacts and Locations

Contacts

Contact: Megan Y Roberts, PhD; 8474913183; ei@northwestern.edu

Contact: Laura J Sudec, MSW; 8474913183; laura.sudec@northwestern.edu

Locations

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

• Principal Investigator: Megan Y Roberts, PhD; Northwestern University

More Information

• Responsible Party: Megan Roberts, Principal Investigator, Northwestern University
• ClinicalTrials.gov Identifier: NCT03803943
• Other Study ID Numbers: 1R01DC016877-01A1 ( U.S. NIH Grant/Contract )
• First Posted: January 15, 2019
• Last Update Posted: March 1, 2021
• Last Verified: February 2021

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.

• 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:

Hearing Loss; Deafness; Hearing Loss, Bilateral; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases