Hearing Loss, BilateralPhase 2NCT03803943
Early Communication Intervention for Toddlers With Hearing Loss
A Phase 2 study testing Parent-Implemented Communication Intervention (PICT) in people with Hearing Loss, Bilateral, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Bilateral
- What is being tested?
- Parent-Implemented Communication Intervention (PICT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2019to 10 Oct 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Parent-Implemented Communication Intervention (PICT), No Intervention - Business-as-usual control
- Keywords
- Hearing Loss, Toddlers, Early Intervention, Parent-mediated intervention
- Medical subject headings
- Hearing Loss, Bilateral, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Implemented Communication Intervention (PICT)Behavioural
Also called PICT
Weekly hour long intervention sessions for 6 months
No Intervention - Business-as-usual controlOther
Also called BAU
Does not receive PICT intervention
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Parent-Implemented Communication Intervention (PICT) |
| No Intervention - Business-as-usual control | Placebo comparator | Participants assigned to the BAU control group will not receive the PICT intervention. Receives: Other: No Intervention - Business-as-usual control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Month 7
Secondary outcomes (5)
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.
Measured: Change from Baseline to Month 24
Spoken Words From the MacArthur-Bates Communicative Development Inventory (MCDI): Words and Sentences - Child
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.
Measured: Change from Baseline to Month 24
Spoken Words From the Language Sample - Child
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.
Measured: 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.
Measured: 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.
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start15 Jun 2019
- Primary completion16 May 2023
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing Loss, BilateralStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Principal investigator, Megan Roberts, Northwestern University
- Investigators
- Megan Y Roberts, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803943
- Sponsor's protocol ID
- 1R01DC016877-01A1
- Status last verified
- Jul 2026
- First submitted
- 8 Jan 2019
- Last updated
- 19 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Communication Intervention for Toddlers With Hearing Loss
- ClinicalTrials.gov ID
- NCT03803943
- Acronym / sponsor ID
- 1R01DC016877-01A1
- Conditions
- Hearing Loss, Bilateral
- Keywords
- Hearing Loss, Toddlers, Early Intervention, Parent-mediated intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Posted 15 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Parent-Implemented Communication Intervention (PICT) | Experimental | Behavioral: 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). |
| No Intervention - Business-as-usual control | Placebo comparator | Other: No Intervention - Business-as-usual controlParticipants assigned to the BAU control group will not receive the PICT intervention. |
Who may qualify
- Ages
- 12 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent-Implemented Communication Intervention (PICT)Also: PICTWeekly hour long intervention sessions for 6 months | Behavioural | Parent-Implemented Communication Intervention (PICT) |
| No Intervention - Business-as-usual controlAlso: BAUDoes not receive PICT intervention | Other | No Intervention - Business-as-usual control |
Primary outcome
Use of Communication Support Strategies - Parent
Time frame: 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
Time frame: 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
Time frame: 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.
5 secondary outcomes
Use of Communication Support Strategies - Parent
Time frame: Change from Baseline to Month 24
Spoken Words From the MacArthur-Bates Communicative Development Inventory (MCDI): Words and Sentences - Child
Time frame: Change from Baseline to Month 24
Spoken Words From the Language Sample - Child
Time frame: Change from Baseline to Month 24
Expressive Communication Standard Score on the Preschool Language Scale - 5th Edition - Child
Time frame: Month 24
Auditory Comprehension Standard Score on the Preschool Language Scale - 5th Edition - Child
Time frame: Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Y Roberts, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Parent-Implemented Communication Intervention (PICT) in people with Hearing Loss, Bilateral, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of Communication Support Strategies - Parent (time frame: Change from Baseline to Month 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.