Hearing Loss, Bilateral
Conditions
Keywords
Hearing Loss, Toddlers, Early Intervention, Parent-mediated intervention
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.
Interventions
BEHAVIORALParent-Implemented Communication Intervention (PICT)
Weekly hour long intervention sessions for 6 months
OTHERNo Intervention - Business-as-usual control
Does not receive PICT intervention
Sponsors
Northwestern University
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors and coders will be naive to experimental condition
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.
Eligibility
Sex/Gender
ALL
Age
12 Months to 18 Months
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of Communication Support Strategies - Parent | Change from Baseline to Month 7 | Parent use of communication support strategies was measured from a 12-minute parent-child interaction in which the dyad plays using a standard set of toys. Interactions were video recorded and coded for 13 items representing subcomponents of seven communication support strategies. Each item was rated on a 5-point scale (1 = novice use, 5 = expert use), reflecting the quality and proficiency of parent strategy use. Items were averaged to yield a Total Composite Score (Min = 1, Max = 5), with higher scores indicating more proficient and consistent use of communication strategies. |
| Total Number of Communicative Acts From the Language Sample - Child | Change from Baseline to Month 7 | During the 10-minute interaction, the child played with toys and wordless picture books. A research assistant transcribed and coded all communicative acts. Each communicative act was assigned a weight reflecting its developmental complexity: gestures and vocalizations = 1 point, single words = 2 points, and multiple-word utterances = 3 points. The Total Weighted Frequency Score (Min = 0, Max = NA) is the sum of the weighted frequency of each act, with higher scores reflecting more frequent and complex communicative acts. |
| Communication and Symbolic Behavior Scales Score - Child | Month 7 | 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). The weighted raw scores for each of the 7 scales were grouped into 3 clusters (social, speech, and symbolic) and combined into a total raw score (min = 0; max = 113). Higher scores indicate better skills. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of Communication Support Strategies - Parent | Change from Baseline to Month 24 | Parent use of communication support strategies was measured from a 12-minute parent-child interaction in which the dyad plays using a standard set of toys. Interactions were video recorded and coded for 13 items representing subcomponents of seven communication support strategies. Each item was rated on a 5-point scale (1 = novice use, 5 = expert use), reflecting the quality and proficiency of parent strategy use. Items were averaged to yield a Total Composite Score (Min = 1, Max = 5), with higher scores indicating more proficient and consistent use of communication strategies. |
| Spoken Words From the MacArthur-Bates Communicative Development Inventory (MCDI): Words and Sentences - Child | Change from Baseline to Month 24 | The MacArthur-Bates Communicative Development Inventory (MCDI): Words and Sentences is a parent-report inventory that measures children's expressive vocabulary. Parents indicated the words their child says to yield the MCDI Total Number of Spoken Words (Min = 0, Max = 680), with higher scores reflecting more words in the child's vocabulary. The change score reported here reflects the value at Month 24 minus the value at baseline. |
| Spoken Words From the Language Sample - Child | Change from Baseline to Month 24 | The language sample included a 10-minute interaction, during which the child played with toys and wordless picture books. Each communicative act was transcribed and assigned a weight reflecting its developmental complexity: gestures and vocalizations = 1 point, single words = 2 points, and multiple-word utterances = 3 points. The Spoken Words Weighted Score (Min = 0, Max = NA) is the sum of the weighted frequency of single words and multiple-word utterances, with higher scores reflecting more frequent and complex use of spoken words. The change score reported here reflects the value at Month 24 minus the value at baseline. |
| Expressive Communication Standard Score on the Preschool Language Scale - 5th Edition - Child | Month 24 | 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 - Child | Month 24 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMegan Y Roberts, PhD
Northwestern University
Participant flow
Pre-assignment details
Randomization occurred at the dyad level, with each dyad consisting of one parent and one child. The dyad was considered the enrolled unit in the study, and each dyad was randomly assigned to either the intervention or control group. In total, 105 parent-child dyads were enrolled in the study. The dyads that enrolled in the study prior to the COVID-19 stay-at-home order in March 2020 were not included in the analysis sample, reported here.
Participants by arm
| Arm | Count |
|---|---|
| Parent-Implemented Communication Intervention (PICT): Children 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).
Parent-Implemented Communication Intervention (PICT): Weekly hour long intervention sessions for 6 months | 46 |
| No Intervention - Business-as-usual control: Children Participants assigned to the BAU control group will not receive the PICT intervention.
No Intervention - Business-as-usual control: Does not receive PICT intervention | 48 |
| Parent-Implemented Communication Intervention (PICT): Parents 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).
Parent-Implemented Communication Intervention (PICT): Weekly hour long intervention sessions for 6 months | 46 |
| No Intervention - Business-as-usual control: Parents Participants assigned to the BAU control group will not receive the PICT intervention.
No Intervention - Business-as-usual control: Does not receive PICT intervention | 48 |
| Total | 188 |
Baseline characteristics
| Characteristic | Parent-Implemented Communication Intervention (PICT): Children | No Intervention - Business-as-usual control: Children | Total | No Intervention - Business-as-usual control: Parents | Parent-Implemented Communication Intervention (PICT): Parents |
|---|---|---|---|---|---|
| Age, Continuous | 15.6 months STANDARD_DEVIATION 1.8 | 15.5 months STANDARD_DEVIATION 2.1 | 15.6 months STANDARD_DEVIATION 1.9 | — | — |
| Communication and Symbolic Behavior Scales Score - Child | 67.5 units on a scale STANDARD_DEVIATION 24.7 | 58.7 units on a scale STANDARD_DEVIATION 23.6 | 63.0 units on a scale STANDARD_DEVIATION 24.4 | — | — |
| Communication Mode - Child No Sign | 32 Participants | 31 Participants | 63 Participants | — | — |
| Communication Mode - Child Sign | 14 Participants | 17 Participants | 31 Participants | — | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 8 Participants | 28 Participants | 7 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 38 Participants | 154 Participants | 37 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 6 Participants | 4 Participants | 0 Participants |
| Hearing Device - Child Cochlear Implant/Bone Conduction | 24 Participants | 28 Participants | 52 Participants | — | — |
| Hearing Device - Child Hearing Aid | 22 Participants | 20 Participants | 42 Participants | — | — |
| Hearing Level - Child mild | 9 Participants | 9 Participants | 18 Participants | — | — |
| Hearing Level - Child moderate | 3 Participants | 9 Participants | 12 Participants | — | — |
| Hearing Level - Child moderately severe | 11 Participants | 5 Participants | 16 Participants | — | — |
| Hearing Level - Child profound | 14 Participants | 17 Participants | 31 Participants | — | — |
| Hearing Level - Child severe | 7 Participants | 6 Participants | 13 Participants | — | — |
| Hearing Level - Child slight | 1 Participants | 2 Participants | 3 Participants | — | — |
| Hearing Level - Child unknown | 1 Participants | 0 Participants | 1 Participants | — | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 3 Participants | 15 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 1 Participants | 10 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 2 Participants | 10 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 12 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) White | 30 Participants | 39 Participants | 140 Participants | 40 Participants | 31 Participants |
| Sex: Female, Male Female | 26 Participants | 34 Participants | 146 Participants | 43 Participants | 43 Participants |
| Sex: Female, Male Male | 20 Participants | 14 Participants | 42 Participants | 5 Participants | 3 Participants |
| Total Number of Communicative Acts from the Language Sample - Child | 54.7 Total Weighted Frequency Score STANDARD_DEVIATION 30 | 49.0 Total Weighted Frequency Score STANDARD_DEVIATION 32.6 | 51.8 Total Weighted Frequency Score STANDARD_DEVIATION 31.3 | — | — |
| Use of Communication Support Strategies - Parent | — | — | 3.10 units on a scale STANDARD_DEVIATION 0.5 | 3.0 units on a scale STANDARD_DEVIATION 0.4 | 3.10 units on a scale STANDARD_DEVIATION 0.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 48 | 0 / 46 | 0 / 48 |
| other Total, other adverse events | 0 / 46 | 1 / 48 | 0 / 46 | 0 / 48 |
| serious Total, serious adverse events | 0 / 46 | 0 / 48 | 0 / 46 | 0 / 48 |
Outcome results
Primary
Communication and Symbolic Behavior Scales Score - Child
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). The weighted raw scores for each of the 7 scales were grouped into 3 clusters (social, speech, and symbolic) and combined into a total raw score (min = 0; max = 113). Higher scores indicate better skills.
Time frame: Month 7
Population: This is an outcome measure of the child participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parent-Implemented Communication Intervention (PICT): Parents | Communication and Symbolic Behavior Scales Score - Child | 104.98 units on a scale | Standard Deviation 24.49 |
| No Intervention - Business-as-usual control: Parents | Communication and Symbolic Behavior Scales Score - Child | 92.24 units on a scale | Standard Deviation 29.61 |
Primary
Total Number of Communicative Acts From the Language Sample - Child
During the 10-minute interaction, the child played with toys and wordless picture books. A research assistant transcribed and coded all communicative acts. Each communicative act was assigned a weight reflecting its developmental complexity: gestures and vocalizations = 1 point, single words = 2 points, and multiple-word utterances = 3 points. The Total Weighted Frequency Score (Min = 0, Max = NA) is the sum of the weighted frequency of each act, with higher scores reflecting more frequent and complex communicative acts.
Time frame: Change from Baseline to Month 7
Population: This is an outcome measure of the child participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parent-Implemented Communication Intervention (PICT): Parents | Total Number of Communicative Acts From the Language Sample - Child | 57.8 Total Weighted Frequency Score | Standard Deviation 57.8 |
| No Intervention - Business-as-usual control: Parents | Total Number of Communicative Acts From the Language Sample - Child | 25.24 Total Weighted Frequency Score | Standard Deviation 50.1 |
Primary
Use of Communication Support Strategies - Parent
Parent use of communication support strategies was measured from a 12-minute parent-child interaction in which the dyad plays using a standard set of toys. Interactions were video recorded and coded for 13 items representing subcomponents of seven communication support strategies. Each item was rated on a 5-point scale (1 = novice use, 5 = expert use), reflecting the quality and proficiency of parent strategy use. Items were averaged to yield a Total Composite Score (Min = 1, Max = 5), with higher scores indicating more proficient and consistent use of communication strategies.
Time frame: Change from Baseline to Month 7
Population: This is an outcome measure of the parent participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parent-Implemented Communication Intervention (PICT): Parents | Use of Communication Support Strategies - Parent | .60 units on a scale | Standard Deviation 0.52 |
| No Intervention - Business-as-usual control: Parents | Use of Communication Support Strategies - Parent | .02 units on a scale | Standard Deviation 0.51 |
Secondary
Auditory Comprehension Standard Score on the Preschool Language Scale - 5th Edition - Child
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: Month 24
Population: This is an outcome measure of the child participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parent-Implemented Communication Intervention (PICT): Parents | Auditory Comprehension Standard Score on the Preschool Language Scale - 5th Edition - Child | 102.46 units on a scale | Standard Deviation 20.27 |
| No Intervention - Business-as-usual control: Parents | Auditory Comprehension Standard Score on the Preschool Language Scale - 5th Edition - Child | 92.14 units on a scale | Standard Deviation 23.8 |
Secondary
Expressive Communication Standard Score on the Preschool Language Scale - 5th Edition - Child
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: Month 24
Population: This is an outcome measure of the child participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parent-Implemented Communication Intervention (PICT): Parents | Expressive Communication Standard Score on the Preschool Language Scale - 5th Edition - Child | 100.44 units on a scale | Standard Deviation 20.05 |
| No Intervention - Business-as-usual control: Parents | Expressive Communication Standard Score on the Preschool Language Scale - 5th Edition - Child | 93.81 units on a scale | Standard Deviation 20.45 |
Secondary
Spoken Words - Child
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 10-minute language sample in which an assessor plays with the child following a standardized protocol.
Time frame: Change from Baseline to Month 24
Secondary
Use of Communication Support Strategies - Parent
Parent use of communication support strategies was measured from a 12-minute parent-child interaction in which the dyad plays using a standard set of toys. Interactions were video recorded and coded for 13 items representing subcomponents of seven communication support strategies. Each item was rated on a 5-point scale (1 = novice use, 5 = expert use), reflecting the quality and proficiency of parent strategy use. Items were averaged to yield a Total Composite Score (Min = 1, Max = 5), with higher scores indicating more proficient and consistent use of communication strategies.
Time frame: Change from Baseline to Month 24
Population: This is an outcome measure of the parent participants only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parent-Implemented Communication Intervention (PICT): Parents | Use of Communication Support Strategies - Parent | .30 units on a scale | Standard Deviation 0.59 |
| No Intervention - Business-as-usual control: Parents | Use of Communication Support Strategies - Parent | .09 units on a scale | Standard Deviation 0.58 |