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| Name | Class |
|---|---|
| Ann & Robert H Lurie Children's Hospital of Chicago | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parent-Implemented Communication Intervention (PICT) | Experimental | 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). |
|
| No Intervention - Business-as-usual control | Placebo Comparator | Participants assigned to the BAU control group will not receive the PICT intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parent-Implemented Communication Intervention (PICT) | Behavioral | Weekly hour long intervention sessions for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline to Month 7 |
| 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. | Change from Baseline to Month 7 |
| 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. | Month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan Y Roberts, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Evanston | Illinois | 60208 | United States |
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.
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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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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. The arm/group title is labeled based on the dyad's assignment and reflects the joint participation of both caregiver and child.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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94 parent-child dyads were randomized at baseline, 46 of whom were allocated to the PICT group and 48 of whom were randomized to the BAU control group.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of the child participant |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This is an outcome measure of the parent participants only. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline to Month 7 |
|
Monthly over 18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crying | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Megan Roberts | Northwestern University | (847) 491-3066 | megan.y.roberts@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 4, 2022 | May 14, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 4, 2025 | Aug 4, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 20, 2021 | Jan 3, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006312 | Hearing Loss, Bilateral |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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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.
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Outcome assessors and coders will be naive to experimental condition
|
| No Intervention - Business-as-usual control | Other | Does not receive PICT intervention |
|
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| Change from Baseline to Month 24 |
| 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. | Change from Baseline to Month 24 |
| 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. | Month 24 |
| 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. | Month 24 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
This is a baseline measure of the child participants only.
| Mean |
| Standard Deviation |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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. | This is a baseline measure of the child participants only. | Mean | Standard Deviation | Total Weighted Frequency Score |
|
| 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. | This is a baseline measure of the child participants only. | Mean | Standard Deviation | units on a scale |
|
| 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. | This is a baseline measure of the parent participants only. | Mean | Standard Deviation | units on a scale |
|
| Hearing Level - Child | Hearing level of child participant | This is a baseline measure of the child participants only. | Count of Participants | Participants |
|
| Communication Mode - Child | Communication mode of the child participant | This is a baseline measure of the child participants only. | Count of Participants | Participants |
|
| Hearing Device - Child | Hearing device of the child participant | This is a baseline measure of the child participants only. | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
| 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. | This is an outcome measure of the child participants only. | Posted | Mean | Standard Deviation | Total Weighted Frequency Score | Change from Baseline to Month 7 |
|
|
|
| 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. | This is an outcome measure of the child participants only. | Posted | Mean | Standard Deviation | units on a scale | Month 7 |
|
|
|
| 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. | This is an outcome measure of the parent participants only. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline to Month 24 |
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|
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| 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. | Not Posted | Change from Baseline to Month 24 | Participants |
| 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. | This is an outcome measure of the child participants only. | Posted | Mean | Standard Deviation | units on a scale | Month 24 |
|
|
|
| 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. | This is an outcome measure of the child participants only. | Posted | Mean | Standard Deviation | units on a scale | Month 24 |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | 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 | 0 | 48 | 0 | 48 | 1 | 48 |
| EG002 | 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 | 0 | 46 | 0 | 46 | 0 | 46 |
| EG003 | 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 | 0 | 48 | 0 | 48 | 0 | 48 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| moderate |
|
| moderately severe |
|
| severe |
|
| profound |
|
| unknown |
|