An interventional study of input cue in Deafness, sponsored by Boston University Charles River Campus. Completed at 1 site in United States. Open to participants aged 18 Months to 60 Months. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Boston University Charles River Campus · Not applicable, Interventional, and Basic science
Mutual exclusivity is a word learning constraint in which the learner assumes that a given word refers to only one category of objects. In spoken languages, mutual exclusivity has been demonstrated in monolingual children as young as 17 months and cross-linguistically, while multilingual learners show an attenuated mutual exclusivity bias. Mutual exclusivity has not been robustly demonstrated in deaf children acquiring American Sign Language (ASL). Further, it is unclear if mutual exclusivity applies to those learning both a signed and a spoken language. Like unimodal bilinguals, bimodal bilingual (BiBi) children learn two words for an object, but these words are separated by modality. A BiBi child could therefore assume that all objects have two words (like unimodal bilinguals) or that all objects have one spoken word and one sign (within-modality mutual exclusivity). The goals of the current study are to demonstrate mutual exclusivity in monolingual deaf children acquiring ASL, and to determine if BiBi deaf children utilize mutual exclusivity within each modality.
The investigators will investigate how deaf children prioritize input cues to word meaning when linguistic cues (i.e. mutual exclusivity) and referential gaze are in conflict in a structured word learning task.
Participants: Deaf children (n=40) ages 18 to 60 months are eligible to participate. Investigators will recruit 60 children to allow for 33% attrition. While the inclusion criteria are the same as other studies, here investigators do use spoken language exposure as a grouping variable, as follows: based on responses to the language background questionnaire regarding exposure to spoken English, participants will be grouped according to language use as monolingual ASL or bimodal bilingual (spoken English/ASL). Participants will be identified as bimodal bilingual is 1) the primary caregiver reports spoken English to communicate with their child (either alone or in conjunction with ASL), and 2) the primary caregiver reports that their child's ability to understand spoken English is at least a 3 on a Likert-type scale ranging from 0-5. Parents in this group will complete the short-form English CDI in addition to the ASL language measures.
Procedure: Participants will sit across a table from an experimenter who will present pairs of objects--one familiar, one novel--with one pair in each of nine trials (three per condition). The experimenter will prompt the participant to give them one of the toys, signing "I WANT YOU-GIVE-ME WHAT?" Then the experimenter will provide a cue; the child's selection will be recorded. In the gaze condition, the cue will be a gaze shift to the familiar object. In the mutual exclusivity condition, the cue will be a novel sign. In the conflict condition, both a gaze shift to the familiar object and a novel sign will be used. The trial order and object pair will be pseudo-randomly assigned.
Planned analysis: Investigators will use an omnibus mixed effects binomial model to determine how well condition and language environment predict the likelihood to select the novel object, with item and child as random factors.
609 studies on the registry are indexed under Deafness; 111 are open to participants now.
This study's enrollment of 48 is above the median of 40 across 411 interventional studies indexed under Deafness.
Browse Deafness studies →Boston University Charles River Campus is the lead sponsor of 154 studies on the registry; 30 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 8 (57%) have results posted.
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Exclusion Criteria:
All participants are provided pairs of objects (one familiar, one novel) with an accompanying prompt. The prompt types are 1) gaze (3 trials); 2) mutual exclusivity (3 trials); or 3) conflict (3 trials)
Other: input cue
The object is labelled with 1) gaze only; 2) novel label only; or 3) conflicting gaze and novel label
Novel Object Selected
In each trial two objects are presented to the child, one novel and one familiar, along with one of three prompt types. Children select one of the two objects on the table in front of them by picking it up and handing it to the experimenter. One each trial, the selected object is scored as novel or familiar based on which object is selected. Data is analyzed as proportion of trials on which the novel object was selected.
Time frame: Trial time frame: 10 seconds, beginning from the end of the experimenter's prompt, i.e. once the experimenter asked the child for an object, the child had 10 seconds to respond by selecting one of the two presented objects.
Participants were recruited from deaf communities in the United States. Recruitment occurred through cooperation with schools and programs serving deaf/hh children and through social media outlets.
| Milestone | Word Learning From Referential Cues |
|---|---|
| Started | 48 |
| Completed | 43 |
| Not completed | 5 |
| Withdrew: Did not provide a code-able response on sufficient trials | 4 |
| Withdrew: Showed a familiarity or novelty preference | 1 |
In each trial two objects are presented to the child, one novel and one familiar, along with one of three prompt types. Children select one of the two objects on the table in front of them by picking it up and handing it to the experimenter. One each trial, the selected object is scored as novel or familiar based on which object is selected. Data is analyzed as proportion of trials on which the novel object was selected.
| prop of trials w novel object selected | Referential Cues to Object |
|---|---|
| gaze condition | .374 ± .327 |
| mutual exclusivity condition | .585 ± .327 |
| conflict condition | .537 ± .336 |
Collected over 15 to 25 minutes, on average 20 minutes. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Referential Cues to Object | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Age, Continuous(months) | All Participants |
|---|---|
| Mean | 42.17 ± 10.47 |
| Sex/Gender, Customized(Participants) | All Participants |
|---|---|
| Male | 21 |
| Female | 21 |
| Unknown | 1 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 27 |
| More than one race | 8 |
| Unknown or Not Reported | 8 |
| Ethnicity (NIH/OMB)(Participants) | All Participants |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 29 |
| Unknown or Not Reported | 9 |
| Language group(Participants) | All Participants |
|---|---|
| Monolingual ASL | 28 |
| Bimodal/Bilingual ASL/English | 15 |
| American Sign Language CDI vocabulary score(proportion of known words out of total) | All Participants |
|---|---|
| Mean | .83 ± .20 |
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Boston University Charles River Campus