Hearing Loss, BilateralPhase 2NCT07205484
Long-Term Outcomes of Early Communication Intervention for Deaf/Hard of Hearing Toddlers
A Phase 2 study testing Parent-Mediated Intervention (PMI) in people with Hearing Loss, Bilateral, run by Northwestern University at 1 site in United States.
Trial summary
The overall goal of this randomized clinical trial is to learn about the effects of a parent-mediated intervention (PMI) designed to support communication outcomes for deaf and hard-of-hearing (DHH) children. Previously, the investigators enrolled 96 DHH children between 12 and 18 months of age and their parents. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Hearing Loss, Bilateral
- What is being tested?
- Parent-Mediated Intervention (PMI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2025to Mar 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Eligibility for the follow-up period of the clinical trial is dependent on enrollment in the initial period of the clinical trial.
Child inclusion criteria were:
- between 12-18 months
- diagnosed with bilateral hearing loss
- no additional diagnoses (e.g., Down syndrome, cerebral palsy, seizure disorder, blindness, etc.)
- one parent with typical hearing
- exposed to some degree of spoken language by their parents.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Early Communication Intervention for Deaf/Hard of Hearing Toddlers: Long-Term Language and Literacy Outcomes
The overall goal of this randomized clinical trial is to learn about the effects of a parent-mediated intervention (PMI) designed to support communication outcomes for deaf and hard-of-hearing (DHH) children. Previously, the investigators enrolled 96 DHH children between 12 and 18 months of age and their parents. Families were randomly assigned to receive either the PMI or a business-as-usual control group. The PMI was a 6-month intervention that included weekly, hour-long Zoom sessions. During the intervention sessions, parents were taught communication support strategies to support their child's language development throughout daily routines and play.
This current period of the trial follows the same children into early elementary school to determine whether the effects of the PMI are long-lasting. The main questions it aims to answer are:
Read more
- Does the PMI improve language, reading, and social communication outcomes in the early school years?
- Does parent involvement during early intervention support continued engagement in their child's education?
The investigators will compare parents and children who received the PMI to those in the business-as-usual control group to determine whether the intervention has lasting effects on these outcomes.
Participants will complete standardized assessments, parent-report surveys, and video-recorded naturalistic interactions. All assessments will be completed remotely.
Read the detailed description
Hearing loss is one of the most prevalent congenital conditions. Recent advances in early detection and technology have contributed to significant improvements in long-term outcomes for deaf/hard-of-hearing (DHH) children. Despite this progress, language and literacy outcomes for school-age DHH children are inconsistent, and many DHH children do not "catch up" to their hearing peers. Closing this gap requires the implementation of effective early communication interventions. Yet, until recently, there was a significant paucity of research on early communication interventions for DHH children. Parent-mediated interventions (PMIs), which involve teaching parents strategies to enhance their child's language learning experiences, are a promising form of early intervention for DHH toddlers. During the previous project period (NCT03803943), 96 DHH children, between 12 and 18 months of age and their parents, were enrolled. Parent-child dyads were randomly assigned to receive either the PMI or business-as-usual control group. The investigators examined the effects of the intervention on (a) parent strategy use and (b) child communication outcomes during and after the 6-month intervention period. The follow-up period of the clinical trial is outlined here.
This trial will be the first large-scale evaluation of the long-term effects of an early communication intervention on school-age language and literacy outcomes for DHH children. The study enrolled 96 parent-child dyads, 88 of whom remain involved and consented to contact for the follow-up period. The investigators will complete follow-up assessments during early elementary school. The investigators plan to examine the long-term effects of the intervention on school-age outcomes and characterize the intermediary mechanisms of these effects. The investigators consider not only how early communication interventions affect subsequent child outcomes, but also how involving parents early in their child's development may lay the foundation for sustained parent engagement as children transition to school-based services. Taken together, the investigators plan to integrate child and parent outcomes to fully characterize how early language learning experiences shape long-term language and literacy outcomes. Understanding the pathways through which early interventions affect the developmental trajectory of DHH children will have widespread implications for research and clinical practice.
- Conditions
- Hearing Loss, Bilateral
- Being tested
- Parent-Mediated Intervention (PMI)
- Keywords
- Hearing Loss, School-Aged Outcomes, Language, Literacy, Early Intervention, Parent-Mediated Intervention
- Medical subject headings
- Hearing Loss, Bilateral, Hearing Loss, Language, Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Mediated Intervention (PMI)Behavioural
Also called Parent-Implemented Communication Intervention (PICT), Parent-Implemented Communication Treatment (PICT)
The PMI consisted of weekly, 1-hour intervention sessions via Zoom for 6 months. In total, the intervention consisted of 26 intervention sessions.
| Study group | Role | What they receive |
|---|---|---|
| Parent-Mediated Intervention (PMI) | Experimental | Participants in both the parent-mediated intervention (PMI) group and the business-as-usual (BAU) control group continued to receive standard community-based early intervention services outside of the clinical trial. In addition to these services, dyads in the PMI group participated in weekly intervention sessions via Zoom for 6 months.
Intervention sessions followed a Teach-Model-Coach-Review framework to support parents in using communication support strategies with their child. Parents were taught seven communication support strategies in a fixed sequence: (1) Setting the Stage, (2) Play and Engage, (3) Respond and Wait, (4) Notice and Say, (5) Show It, (6) Contrast It, and (7) Add On. These strategies focused on helping parents create opportunities for language learning during everyday routines and play, notice and respond to their child's communication, and model rich, salient language. Receives: Behavioral: Parent-Mediated Intervention (PMI) |
| Business-As-Usual (BAU) Control | No intervention | Participants in both the parent-mediated intervention (PMI) group and the business-as-usual (BAU) control group continued to receive standard community-based early intervention services outside of the clinical trial. Dyads in the BAU control group did not receive the PMI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Evaluation of Language Fundamentals, Fifth Edition (CELF-5)
The Clinical Evaluation of Language Fundamentals, Fifth Edition (CELF-5) is a standardized assessment of language development. The Core Language Standard Score (M = 100, SD = 15) reflects the child's global language ability, with higher scores indicating better language skills.
Measured: 7 - 8 years old
Peer-Peer Interaction, Pragmatic Observational Measure (POM)
The Pragmatic Observational Measure (POM), a rating scale of pragmatic skills, will be scored during a naturalistic peer-peer interaction. The POM includes 27 items, capturing a range of pragmatic skills, rated on a 4-point scale (1 = rarely or never observed; 4 = almost always observed). The POM Total Raw Score (Min = 27, Max = 108) reflects the child's pragmatic skills, with higher scores indicating better pragmatic skills.
Measured: 7 - 8 years old
Woodcock Reading Mastery Tests, Third Edition (WRMT-III)
The Woodcock Reading Mastery Tests, Third Edition (WRMT-III) is a standardized assessment of reading development. The Total Reading Cluster Standard Score (M = 100, SD = 15) reflects the child's global reading ability, with higher scores indicating better reading skills.
Measured: 7 - 8 years old
Secondary outcomes (5)
Parent-Child Interaction, Keys to Interactive Parenting Scale (KIPS)
The Keys to Interactive Parenting Scale (KIPS), a rating scale of parenting behaviors, will be scored during a naturalistic parent-child interaction.The KIPS includes 12 items, capturing a range of parenting behaviors, rated on a 5-point scale, with higher scores reflecting higher quality parent behaviors. The KIPS Total Mean Score (Min = 1.0, Max = 5.0), calculated as the average of all 12 items, reflects the overall quality of parenting behaviors.
Measured: 5 - 6 years old
Parent Empowerment and Efficacy Measure (PEEM)
The Parent Empowerment and Efficacy Measure (PEEM) is a self-report questionnaire assessing parents' confidence in their role and their ability to support their child's development. The measure includes 20 items rated on a 10-point scale (1 = no agreement; 10 = complete agreement). The PEEM Total Raw Score (Min = 20, Max = 200) reflects overall parenting self-efficacy, with higher scores indicating greater self-efficacy.
Measured: 5 - 6 years old
Parental Involvement Survey in Their Child's Elementary Studies (PISCES)
The Parental Involvement Survey in Their Child's Elementary Studies (PISCES) is a parent-report questionnaire that assesses parent involvement in school-related activities. The measure includes 56 items rated on a 4-point Likert scale (1 = strongly disagree; 4 = strongly agree). The PISCES Total Raw Score (Min = 56, Max = 224) reflects the extent of parent involvement in their child's education, with higher scores indicating greater involvement.
Measured: 5 - 6 years old
The Parent Advocacy Skills and Comfort Survey
The Parent Advocacy Skills and Comfort Survey is a parent-report questionnaire assessing caregivers' ability to advocate for their child's educational needs. The survey includes 10 items rated on a 5-point Likert scale (1 = strongly disagree; 5 = strongly agree). The Total Raw Score (Min = 10, Max = 50) reflects overall advocacy skills and confidence, with higher scores indicating greater advocacy skills and confidence.
Measured: 5 - 6 years old
Clinical Evaluation of Language Fundamentals, Fifth Edition (CELF-5)
The Clinical Evaluation of Language Fundamentals, Fifth Edition (CELF-5) is a standardized assessment of language development. The Core Language Standard Score (M = 100, SD = 15) reflects the child's global language ability, with higher scores indicating better language skills.
Measured: 5 - 6 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start12 Aug 2025
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parent-child dyads were randomly assigned to the parent-mediated intervention (PMI) or business-as-usual (BAU) control group. Randomization was stratified on hearing device and communication mode. Hearing device was dichotomized as either (1) hearing aid or (2) cochlear implant, cochlear implant candidate, or bone conduction device. Communication mode was dichotomized as using visual communication with the child (1) less than 10% of the time or (2) 10% or more of the time.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Roberts, Northwestern University
- Investigators
- Megan Y Roberts, PhD, CCC-SLP, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205484
- Sponsor's protocol ID
- 2R01DC016877-06A1
- Status last verified
- May 2026
- First submitted
- 6 Aug 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All participant-level data related to the primary and secondary outcomes of the clinical trial will be preserved and shared via Dryad. All shared data will be de-identified by using a unique study identifier and age in months rather than date of birth. This will allow for the replication of all analyses for the primary aims and for other investigators to answer other questions that are not related to the study aims. The final results of the study will be uploaded to clinicaltrials.gov. All data as described above will be shared, as allowed by informed consents. The only data that will not be shared are the video recordings of the observational peer-peer and parent-child interactions, which contain participants' faces.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Communication Intervention for Deaf/Hard of Hearing Toddlers: Long-Term Language and Literacy Outcomes
- ClinicalTrials.gov ID
- NCT07205484
- Acronym / sponsor ID
- 2R01DC016877-06A1
- Conditions
- Hearing Loss, Bilateral
- Keywords
- Hearing Loss, School-Aged Outcomes, Language, Literacy, Early Intervention, Parent-Mediated Intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this randomized clinical trial is to learn about the effects of a parent-mediated intervention (PMI) designed to support communication outcomes for deaf and hard-of-hearing (DHH) children. Previously, the investigators enrolled 96 DHH children between 12 and 18 months of age and their parents. Families were randomly assigned to receive either the PMI or a business-as-usual control group. The PMI was a 6-month intervention that included weekly, hour-long Zoom sessions. During the intervention sessions, parents were taught communication support strategies to support their child's language development throughout daily routines and play.
This current period of the trial follows the same children into early elementary school to determine whether the effects of the PMI are long-lasting. The main questions it aims to answer are:
- Does the PMI improve language, reading, and social communication outcomes in the early school years?
- Does parent involvement during early intervention support continued engagement in their child's education?
The investigators will compare parents and children who received the PMI to those in the business-as-usual control group to determine whether the intervention has lasting effects on these outcomes.
Participants will complete standardized assessments, parent-report surveys, and video-recorded naturalistic interactions. All assessments will be completed remotely.
Detailed description
Hearing loss is one of the most prevalent congenital conditions. Recent advances in early detection and technology have contributed to significant improvements in long-term outcomes for deaf/hard-of-hearing (DHH) children. Despite this progress, language and literacy outcomes for school-age DHH children are inconsistent, and many DHH children do not "catch up" to their hearing peers. Closing this gap requires the implementation of effective early communication interventions. Yet, until recently, there was a significant paucity of research on early communication interventions for DHH children. Parent-mediated interventions (PMIs), which involve teaching parents strategies to enhance their child's language learning experiences, are a promising form of early intervention for DHH toddlers. During the previous project period (NCT03803943), 96 DHH children, between 12 and 18 months of age and their parents, were enrolled. Parent-child dyads were randomly assigned to receive either the PMI or business-as-usual control group. The investigators examined the effects of the intervention on (a) parent strategy use and (b) child communication outcomes during and after the 6-month intervention period. The follow-up period of the clinical trial is outlined here.
This trial will be the first large-scale evaluation of the long-term effects of an early communication intervention on school-age language and literacy outcomes for DHH children. The study enrolled 96 parent-child dyads, 88 of whom remain involved and consented to contact for the follow-up period. The investigators will complete follow-up assessments during early elementary school. The investigators plan to examine the long-term effects of the intervention on school-age outcomes and characterize the intermediary mechanisms of these effects. The investigators consider not only how early communication interventions affect subsequent child outcomes, but also how involving parents early in their child's development may lay the foundation for sustained parent engagement as children transition to school-based services. Taken together, the investigators plan to integrate child and parent outcomes to fully characterize how early language learning experiences shape long-term language and literacy outcomes. Understanding the pathways through which early interventions affect the developmental trajectory of DHH children will have widespread implications for research and clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parent-child dyads were randomly assigned to the parent-mediated intervention (PMI) or business-as-usual (BAU) control group. Randomization was stratified on hearing device and communication mode. Hearing device was dichotomized as either (1) hearing aid or (2) cochlear implant, cochlear implant candidate, or bone conduction device. Communication mode was dichotomized as using visual communication with the child (1) less than 10% of the time or (2) 10% or more of the time.
| Arm | Type | Receives |
|---|---|---|
| Parent-Mediated Intervention (PMI) | Experimental | Behavioral: Parent-Mediated Intervention (PMI)Participants in both the parent-mediated intervention (PMI) group and the business-as-usual (BAU) control group continued to receive standard community-based early intervention services outside of the clinical trial. In addition to these services, dyads in the PMI group participated in weekly intervention sessions via Zoom for 6 months. Intervention sessions followed a Teach-Model-Coach-Review framework to support parents in using communication support strategies with their child. Parents were taught seven communication support strategies in a fixed sequence: (1) Setting the Stage, (2) Play and Engage, (3) Respond and Wait, (4) Notice and Say, (5) Show It, (6) Contrast It, and (7) Add On. These strategies focused on helping parents create opportunities for language learning during everyday routines and play, notice and respond to their child's communication, and model rich, salient language. |
| Business-As-Usual (BAU) Control | No intervention | –Participants in both the parent-mediated intervention (PMI) group and the business-as-usual (BAU) control group continued to receive standard community-based early intervention services outside of the clinical trial. Dyads in the BAU control group did not receive the PMI. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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-Mediated Intervention (PMI)Also: Parent-Implemented Communication Intervention (PICT), Parent-Implemented Communication Treatment (PICT)The PMI consisted of weekly, 1-hour intervention sessions via Zoom for 6 months. In total, the intervention consisted of 26 intervention sessions. | Behavioural | Parent-Mediated Intervention (PMI) |
Primary outcome
Clinical Evaluation of Language Fundamentals, Fifth Edition (CELF-5)
Time frame: 7 - 8 years old
The Clinical Evaluation of Language Fundamentals, Fifth Edition (CELF-5) is a standardized assessment of language development. The Core Language Standard Score (M = 100, SD = 15) reflects the child's global language ability, with higher scores indicating better language skills.
Peer-Peer Interaction, Pragmatic Observational Measure (POM)
Time frame: 7 - 8 years old
The Pragmatic Observational Measure (POM), a rating scale of pragmatic skills, will be scored during a naturalistic peer-peer interaction. The POM includes 27 items, capturing a range of pragmatic skills, rated on a 4-point scale (1 = rarely or never observed; 4 = almost always observed). The POM Total Raw Score (Min = 27, Max = 108) reflects the child's pragmatic skills, with higher scores indicating better pragmatic skills.
Woodcock Reading Mastery Tests, Third Edition (WRMT-III)
Time frame: 7 - 8 years old
The Woodcock Reading Mastery Tests, Third Edition (WRMT-III) is a standardized assessment of reading development. The Total Reading Cluster Standard Score (M = 100, SD = 15) reflects the child's global reading ability, with higher scores indicating better reading skills.
5 secondary outcomes
Parent-Child Interaction, Keys to Interactive Parenting Scale (KIPS)
Time frame: 5 - 6 years old
Parent Empowerment and Efficacy Measure (PEEM)
Time frame: 5 - 6 years old
Parental Involvement Survey in Their Child's Elementary Studies (PISCES)
Time frame: 5 - 6 years old
The Parent Advocacy Skills and Comfort Survey
Time frame: 5 - 6 years old
Clinical Evaluation of Language Fundamentals, Fifth Edition (CELF-5)
Time frame: 5 - 6 years old
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: Yes. All participant-level data related to the primary and secondary outcomes of the clinical trial will be preserved and shared via Dryad. All shared data will be de-identified by using a unique study identifier and age in months rather than date of birth. This will allow for the replication of all analyses for the primary aims and for other investigators to answer other questions that are not related to the study aims. The final results of the study will be uploaded to clinicaltrials.gov. All data as described above will be shared, as allowed by informed consents. The only data that will not be shared are the video recordings of the observational peer-peer and parent-child interactions, which contain participants' faces.
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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.
Megan Y Roberts, PhD, CCC-SLP 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-Mediated Intervention (PMI) 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?
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: enrolling by invitation, as of the sponsor's last update on 1 Jun 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical Evaluation of Language Fundamentals, Fifth Edition (CELF-5) (time frame: 7 - 8 years old). 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 1 Jun 2026.