Early Communication Intervention for Toddlers With Hearing Loss

NCT ID: NCT03803943

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-15
• Study Completion Date: 2024-10-10

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.

Conditions

Hearing Loss, Bilateral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Parent-Implemented Communication Intervention (PICT)

Intervention Type: BEHAVIORAL

Weekly hour long intervention sessions for 6 months

No Intervention - Business-as-usual control

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

Group Type: PLACEBO_COMPARATOR

No Intervention - Business-as-usual control

Intervention Type: OTHER

Does not receive PICT intervention

Interventions

Parent-Implemented Communication Intervention (PICT)

Weekly hour long intervention sessions for 6 months

Intervention Type: BEHAVIORAL

No Intervention - Business-as-usual control

Does not receive PICT intervention

Intervention Type: OTHER

Other Intervention Names

PICT; BAU

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)

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Megan Roberts

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Megan Y Roberts, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Evanston, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01DC016877-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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