Clinical trial NCT03803943: Early Communication Intervention for Toddlers With Hearing Loss
Official title: Early Communication Intervention for Toddlers With Hearing Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hearing Loss, Bilateral
Keywords: Hearing Loss
Toddlers
Early Intervention
Parent-mediated intervention
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Ann & Robert H Lurie Children's Hospital of Chicago
First posted: 2019-01-15
Enrollment: 105
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Caregiver Use of Communication Support Strategies
timeFrame: Change in monthly samples between pre and post when the child is 12 to 18 months (during intervention)
measure: Total number of pre-symbolic communicative acts from the Language Sample
timeFrame: Change in monthly samples between pre and post when the child is 12 to 18 months (during intervention)
measure: Total Scaled Score on the Communication and Symbolic Behavior Scales - Developmental Profile
timeFrame: Post (immediately after intervention when the child is 18 months)
Secondary outcomes:
measure: Caregiver Use of Communication Support Strategies
timeFrame: Monthly, up to 18 months, between post and follow-up when the child is 18 to 36 months (after intervention)
measure: Child Spoken Words
timeFrame: Monthly, up to 18 months, between post and follow-up when the child is 18 to 36 months (after intervention)
measure: Expressive Communication Standard Score on the Preschool Language Scale - 5th Edition
timeFrame: Follow up (18 months after the study start when child is 36 months)
measure: Auditory Comprehension Standard Score on the Preschool Language Scale - 5th Edition
timeFrame: Follow up (18 months after the study start when child is 36 months)
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Megan Y Roberts, PhD
role: PRINCIPAL_INVESTIGATOR
References: