Developmental Language DisorderCABVINCT07915115
Computer-Assisted Vocabulary Intervention for Spanish-English Bilingual Children With Developmental Language Disorder
A study testing Bilingual computer-assisted vocabulary intervention (CABVI), English-only computer-assisted vocabulary intervention (CABVI) and Usual English-language school services in people with Developmental Language Disorder, run by Texas Christian University.
Trial summary
This study will examine whether computer-assisted vocabulary instruction in Spanish and English helps young bilingual children with developmental language disorder learn and use vocabulary. It will include 120 Spanish-English bilingual children in kindergarten or first grade. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Developmental Language Disorder
- What is being tested?
- Bilingual computer-assisted vocabulary intervention (CABVI), English-only computer-assisted vocabulary intervention (CABVI) and Usual English-language school services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to Apr 2031
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Child participants:
- Age 5 years or older and enrolled in kindergarten or first grade at an authorized participating study site.
- Spanish-English emergent bilingual with regular Spanish exposure at home, including Spanish-primary or balanced bilingual homes, documented by parent questionnaire.
- Primary Test of Nonverbal Intelligence score of at least 70.
- Passes pure-tone hearing screening at 25 dB HL at 1000, 2000 and 4000 Hz.
- Names fewer than 12 of the 36 intervention target concepts before allocation, using the item-level bilingual conceptual union across complete Spanish and English Naming administrations. Count a concept once when an accepted label is produced in either language; 0-11 known concepts meets this vocabulary criterion, while 12-36 does not. Incomplete or unresolved administrations remain pending.
Show all 15Show fewer
- Comprehensive age-appropriate bilingual assessment and converging clinical information support classification as developmental language disorder or typical language development.
- Children in the DLD cohort have at least one relevant language/vocabulary individualized education program goal; other goals are permitted.
- Written parent permission and the applicable child-assent process.
- Adult clinician participants:
- At least 18 years old.
- School-based English-monolingual or English-dominant speech-language pathologist, or appropriately supervised speech-language pathology assistant, authorized to provide the assigned school services.
- Caseload includes eligible Spanish-English children with developmental language disorder and relevant language/vocabulary individualized education program goals.
- Written adult consent before adult research screening or questionnaires.
- Participation during one project year only.
Who cannot join
- Does not meet the inclusion criteria for the respective child or adult cohort.
- Comprehensive assessment does not support classification in the intended child study group.
- Adult clinician has participated in an earlier project year.
- Declining optional audio/video recording does not itself exclude participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Trial of Computer-Assisted Bilingual Vocabulary Intervention in Emergent Bilinguals With Developmental Language Disorder
This study will examine whether computer-assisted vocabulary instruction in Spanish and English helps young bilingual children with developmental language disorder learn and use vocabulary. It will include 120 Spanish-English bilingual children in kindergarten or first grade. Eighty children with developmental language disorder will be assigned by chance to bilingual computer-assisted vocabulary instruction, English-only computer-assisted vocabulary instruction, or usual English-language school services. Forty children with typical language development will receive bilingual instruction without random assignment, providing a developmental comparison.
The program teaches 36 vocabulary concepts through 24 small-group sessions, ordinarily over about six weeks. School-calendar disruptions may extend the schedule. Vocabulary will be assessed in both languages before intervention, immediately afterward, and approximately six weeks after the final session. The primary outcomes are naming and defining the taught concepts in each language.
The implementation component anticipates 15 unique school speech-language pathologists or appropriately supervised speech-language pathology assistants across five project years, with a planning target of approximately 3 new clinicians per year. Annual recruitment may vary with eligible caseloads. This component examines delivery fidelity, feasibility, clinician confidence, usability and satisfaction. Teacher and parent feedback about children's vocabulary use, communication confidence and engagement will also be collected after intervention and at follow-up where feasible.
Read the detailed description
The awarded CABVI R01 addresses three aims. Aim 1 compares bilingual CABVI, English-only CABVI and usual English-language school services among Spanish-English emergent bilingual children with developmental language disorder. Aim 2 compares vocabulary growth among children with and without developmental language disorder receiving bilingual CABVI. Aim 3 examines implementation fidelity, feasibility, clinician confidence, usability and satisfaction.
The child sample includes 80 children with developmental language disorder randomized approximately 1:1:1 after baseline assessment, using blocked allocation stratified by speech-language pathologist or interventionist, and 40 typically developing children receiving bilingual CABVI without randomization. Children remain in their assigned condition.
CABVI uses fixed groups of three to five children and six instructional units, each containing four sequential sessions. The 24 sessions ordinarily take about six weeks, with four sessions completed within seven days. Each session includes approximately 45 minutes of instruction within a 60-minute school scheduling block for transitions and breaks. School-calendar disruptions may extend the calendar while preserving the planned sessions and sequence. Individual absences do not lead to individual makeup sessions or transfers; whole-group cancellations may be rescheduled for the same group.
Both CABVI conditions teach the same 36 concepts through shared reading, receptive and expressive vocabulary activities, movement and songs, and supported conversations. Bilingual CABVI uses Spanish in Sessions 1 and 3 of each unit and English in Sessions 2 and 4. English-only CABVI uses English throughout. Qualified school clinicians or appropriately trained and supervised study clinicians provide adult oversight. Usual-care services have no CABVI-matched research dose; weekly logs document actual frequency, duration, content and attendance. Required school and individualized education program services continue independently of participation.
Outcome assessments occur before intervention and allocation, during the school week after the final intervention session, and approximately six weeks after that session. English and Spanish are assessed on different days. The first assessment language is counterbalanced across children independently of intervention allocation, and each child's assigned order is preserved across timepoints. Both vocabulary blocks in the assigned first language precede the other language's blocks. Within each language, generalization, Naming and incidental expressive tasks precede Definition, Elaboration, target receptive and incidental receptive tasks. Narrative retells may be scheduled separately. All participant assessments and intervention procedures take place at participating schools. Masked assessors do not test children whose intervention they delivered or supervised and do not receive condition-revealing records. Compatible modules may be combined and visits divided for school scheduling, fatigue or willingness while preserving sequence and timing; no teaching or corrective feedback is provided during testing.
The four primary outcomes are binary Naming and Definition scores for the 36 directly taught concepts, separately in Spanish and English. Elaboration is a secondary picture-supported measure scoring 0-3 new distinct accurate target-related ideas per concept beyond all information in its preceding Definition exchange. Additional pre-specified outcomes include contextualized expressive generalization, target receptive recognition, exploratory expressive and receptive knowledge of 15 selected incidental concepts, and narrative mean length of utterance in words and number of different word roots, reported separately for Spanish- and English-elicited retells. The outcome plan combines the awarded R01 core with later prespecified measures selected for this study.
The implementation component anticipates 15 unique school-based SLPs or appropriately supervised SLPAs across five project years, targeting approximately 3 new clinicians per year with variation by eligible DLD caseloads. Each adult participates during one project year. Adult participants are distinct from hired research personnel and student clinicians and are not automatically randomized with the children. Data include independent fidelity observations, session completion and burden records, pre/post confidence, and post-implementation usability, satisfaction and feedback. Teacher and parent ratings address perceived child vocabulary use, communication confidence and engagement after intervention and at six-week follow-up where feasible. Analyses distinguish the randomized DLD comparison, the developmental comparison within bilingual CABVI, and implementation outcomes.
The same fixed assessment pictures are reused at pretest, immediate posttest and six-week follow-up. They differ from intervention pictures; they are not previously unseen at every assessment. The 15 incidental concepts are tiny, enormous, curious, bright, together, carefully, help, inside, clap, drag, last, whole, again, on and remember. They occur in instructional stories, elaborations, routines or directions outside the 36 direct targets. These are exploratory researcher-developed measures; psychometric validation of this exact assessment is not claimed. Independently score a planned 20% of outcomes and narrative transcripts where adequate permitted source records support it, retaining original ratings and adjudication.
- Conditions
- Developmental Language Disorder
- Being tested
- Bilingual computer-assisted vocabulary intervention (CABVI), English-only computer-assisted vocabulary intervention (CABVI), Usual English-language school services
- Keywords
- Spanish-English bilingual children, Emergent bilinguals, Vocabulary intervention, Computer-assisted language intervention, Word learning, Bilingual language development
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilingual computer-assisted vocabulary intervention (CABVI)Behavioural
Behavioral vocabulary intervention using the CABVI app with trained adult oversight in fixed groups of three to five children. Twenty-four planned sessions teach 36 concepts across six units. Each session includes approximately 45 minutes of instruction within a 60-minute school block. Spanish is used in Sessions 1 and 3 of each unit and English in Sessions 2 and 4. Activities include shared reading, receptive and expressive vocabulary practice, songs and movement, and supported conversations. Four sessions ordinarily occur within seven days, for about six weeks total; school-calendar disruptions may extend the schedule while preserving session sequence.
English-only computer-assisted vocabulary intervention (CABVI)Behavioural
Computer-assisted behavioral vocabulary intervention using the same 36 concepts, instructional content, 24-session sequence, fixed groups of three to five children, and planned dose as bilingual CABVI. All instruction is delivered in English. Sessions include approximately 45 minutes of instruction within a 60-minute school block, ordinarily four sessions within seven days over about six weeks. School-calendar disruptions may extend the schedule while preserving session sequence. Trained adults oversee the shared reading, receptive and expressive vocabulary activities, songs and movement, and supported conversations.
Usual English-language school servicesBehavioural
Usual English-language school services without a CABVI-matched research dose. Weekly logs document actual service frequency, duration, content, and attendance. Required educational and individualized education program services continue independently of study participation.
| Study group | Role | What they receive |
|---|---|---|
| Bilingual CABVI in children with DLD | Experimental | Spanish-English bilingual children with developmental language disorder are randomized to bilingual CABVI. The computer-assisted behavioral vocabulary program teaches 36 concepts in 24 small-group sessions, ordinarily over about six weeks. Each session includes approximately 45 minutes of instruction within a 60-minute school block. Sessions 1 and 3 of each unit are in Spanish; Sessions 2 and 4 are in English. School-calendar disruptions may extend the schedule while preserving the planned sequence. Receives: Behavioral: Bilingual computer-assisted vocabulary intervention (CABVI) |
| English-only CABVI in children with DLD | Active comparator | Spanish-English bilingual children with developmental language disorder are randomized to English-only CABVI. This condition uses the same computer-assisted behavioral vocabulary content, 36 concepts, 24-session sequence, small-group format, and planned dose as bilingual CABVI, with all instruction delivered in English. Sessions include approximately 45 minutes of instruction within a 60-minute school block, ordinarily over about six weeks, with school-calendar extensions as needed. Receives: Behavioral: English-only computer-assisted vocabulary intervention (CABVI) |
| Usual English-language school services in children with DLD | Active comparator | Spanish-English bilingual children with developmental language disorder are randomized to their usual English-language school services. A CABVI-matched research dose is not imposed. Weekly logs document actual service frequency, duration, content, and attendance. Required educational and individualized education program services continue independently of study participation. Receives: Behavioral: Usual English-language school services |
| Bilingual CABVI in typically developing children | Experimental | Forty Spanish-English bilingual children with typical language development receive bilingual CABVI without randomization, providing a developmental comparison. They receive the same 36-concept, 24-session program and planned dose as the bilingual CABVI group with developmental language disorder. Sessions 1 and 3 of each unit are in Spanish; Sessions 2 and 4 are in English. Delivery is ordinarily completed over about six weeks, with school-calendar extensions as needed. Receives: Behavioral: Bilingual computer-assisted vocabulary intervention (CABVI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target vocabulary Naming in Spanish
Researcher-developed picture Naming task for 36 directly taught concepts in Spanish. Images differ from intervention pictures and are reused across assessment timepoints. After any clearly other-language-only initial response, regardless of accuracy, give one fixed reminder to answer in Spanish, without translation or answer cues. An accepted requested-language label initially or after that reminder earns 1; incorrect, absent or other-language-only responses earn 0. Mixed responses containing an accepted requested-language label need no reminder. Record initial response, reminder and subsequent response separately; retain other-language conceptual knowledge separately. Complete-inventory total: 0-36; higher scores indicate greater requested-language Naming knowledge. Record actual denominators; refused, unadministered and uninterpretable items remain missing.
Measured: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
Target vocabulary Definition in Spanish
Researcher-developed Definition task for 36 directly taught concepts in Spanish, without a picture. Supply the label and allow up to THREE TOTAL fixed neutral prompts: the initial meaning question and up to two neutral rephrasings. Continue only when no clearly accurate requested-language attribute, function or description has emerged and the child remains willing. Once binary credit is clear, stop extra prompting but let the child finish all volunteered information. No answer cues or correctness feedback. Accurate attribute, function or description: 1; incorrect, irrelevant, label-only or absent response after valid administration: 0. Preserve all prompts and responses for scoring and Elaboration exclusions. Complete-inventory total: 0-36; higher scores indicate greater semantic knowledge. Record actual denominators; refused, unadministered and uninterpretable items remain missing.
Measured: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
Target vocabulary Naming in English
Researcher-developed picture Naming task for 36 directly taught concepts in English. Images differ from intervention pictures and are reused across assessment timepoints. After any clearly other-language-only initial response, regardless of accuracy, give one fixed reminder to answer in English, without translation or answer cues. An accepted requested-language label initially or after that reminder earns 1; incorrect, absent or other-language-only responses earn 0. Mixed responses containing an accepted requested-language label need no reminder. Record initial response, reminder and subsequent response separately; retain other-language conceptual knowledge separately. Complete-inventory total: 0-36; higher scores indicate greater requested-language Naming knowledge. Record actual denominators; refused, unadministered and uninterpretable items remain missing.
Measured: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
Target vocabulary Definition in English
Researcher-developed Definition task for 36 directly taught concepts in English, without a picture. Supply the label and allow up to THREE TOTAL fixed neutral prompts: the initial meaning question and up to two neutral rephrasings. Continue only when no clearly accurate requested-language attribute, function or description has emerged and the child remains willing. Once binary credit is clear, stop extra prompting but let the child finish all volunteered information. No answer cues or correctness feedback. Accurate attribute, function or description: 1; incorrect, irrelevant, label-only or absent response after valid administration: 0. Preserve all prompts and responses for scoring and Elaboration exclusions. Complete-inventory total: 0-36; higher scores indicate greater semantic knowledge. Record actual denominators; refused, unadministered and uninterpretable items remain missing.
Measured: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
Secondary outcomes (2)
Target vocabulary Elaboration in Spanish
Researcher-developed picture-supported Elaboration task for 36 directly taught concepts in Spanish. After the Definition block, show the fixed concept picture and ask for something ELSE about the word, with up to two neutral continuations. Score 0-3 distinct accurate target-relevant ideas not expressed anywhere in that item's preceding Definition exchange, including volunteered details. Exclude every earlier Definition fact, repeated idea, unrelated scene detail and target-label repetition alone. Accurate knowledge beyond the picture may count. Preserve Definition evidence and each newly credited idea; record other-language contributions separately. Images are reused across timepoints and differ from intervention images. Complete-inventory total: 0-108; higher scores indicate more additional information with picture support. Record actual denominators; refused, unadministered and uninterpretable items remain missing.
Measured: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
Target vocabulary Elaboration in English
Researcher-developed picture-supported Elaboration task for 36 directly taught concepts in English. After the Definition block, show the fixed concept picture and ask for something ELSE about the word, with up to two neutral continuations. Score 0-3 distinct accurate target-relevant ideas not expressed anywhere in that item's preceding Definition exchange, including volunteered details. Exclude every earlier Definition fact, repeated idea, unrelated scene detail and target-label repetition alone. Accurate knowledge beyond the picture may count. Preserve Definition evidence and each newly credited idea; record other-language contributions separately. Images are reused across timepoints and differ from intervention images. Complete-inventory total: 0-108; higher scores indicate more additional information with picture support. Record actual denominators; refused, unadministered and uninterpretable items remain missing.
Measured: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Language DisorderStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel study of 120 Spanish-English bilingual children in kindergarten or first grade. After eligibility and baseline assessment, 80 children with developmental language disorder are randomized approximately 1:1:1 to bilingual CABVI, English-only CABVI, or usual English-language school services, using blocked allocation stratified by SLP/interventionist. Forty typically developing children receive bilingual CABVI without randomization as a developmental comparison. Children remain in their assigned condition. A separate implementation component evaluates fidelity, feasibility, confidence, usability and satisfaction among 15 anticipated unique school clinician participants across five project years, targeting approximately 3 new clinicians per year. Annual recruitment may vary with eligible DLD caseloads. Planned total enrollment is 135: 120 children and 15 clinicians.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Jean F Rivera Perez, PhD, Principal investigator, Texas Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915115
- Sponsor's protocol ID
- IRB#2026-128
- Other IDs
- 1R01DC023613-01
- Acronym
- CABVI
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified child participant data will be shared, including standardized assessment results, proximal assessment task results, intervention outcomes, and demographic information, with study documentation and analytic code. Data will be deposited in a controlled-access generalist repository participating in the NIH Generalist Repository Ecosystem Initiative. Supporting materials include the study protocol, data collection forms, manuals, and study-created assessments. Direct identifiers, the linkage key, and audio/video recordings will not be shared. Indirect identifiers will be reviewed to reduce re-identification risk. Sharing will follow the approved consent, data-sharing agreement, and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Computer-Assisted Bilingual Vocabulary Intervention in Emergent Bilinguals With Developmental Language Disorder
- ClinicalTrials.gov ID
- NCT07915115
- Acronym / sponsor ID
- CABVI / IRB#2026-128
- Conditions
- Developmental Language Disorder
- Keywords
- Spanish-English bilingual children, Emergent bilinguals, Vocabulary intervention, Computer-assisted language intervention, Word learning, Bilingual language development
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 4 Nov 2026 (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.
This study will examine whether computer-assisted vocabulary instruction in Spanish and English helps young bilingual children with developmental language disorder learn and use vocabulary. It will include 120 Spanish-English bilingual children in kindergarten or first grade. Eighty children with developmental language disorder will be assigned by chance to bilingual computer-assisted vocabulary instruction, English-only computer-assisted vocabulary instruction, or usual English-language school services. Forty children with typical language development will receive bilingual instruction without random assignment, providing a developmental comparison.
The program teaches 36 vocabulary concepts through 24 small-group sessions, ordinarily over about six weeks. School-calendar disruptions may extend the schedule. Vocabulary will be assessed in both languages before intervention, immediately afterward, and approximately six weeks after the final session. The primary outcomes are naming and defining the taught concepts in each language.
The implementation component anticipates 15 unique school speech-language pathologists or appropriately supervised speech-language pathology assistants across five project years, with a planning target of approximately 3 new clinicians per year. Annual recruitment may vary with eligible caseloads. This component examines delivery fidelity, feasibility, clinician confidence, usability and satisfaction. Teacher and parent feedback about children's vocabulary use, communication confidence and engagement will also be collected after intervention and at follow-up where feasible.
Detailed description
The awarded CABVI R01 addresses three aims. Aim 1 compares bilingual CABVI, English-only CABVI and usual English-language school services among Spanish-English emergent bilingual children with developmental language disorder. Aim 2 compares vocabulary growth among children with and without developmental language disorder receiving bilingual CABVI. Aim 3 examines implementation fidelity, feasibility, clinician confidence, usability and satisfaction.
The child sample includes 80 children with developmental language disorder randomized approximately 1:1:1 after baseline assessment, using blocked allocation stratified by speech-language pathologist or interventionist, and 40 typically developing children receiving bilingual CABVI without randomization. Children remain in their assigned condition.
CABVI uses fixed groups of three to five children and six instructional units, each containing four sequential sessions. The 24 sessions ordinarily take about six weeks, with four sessions completed within seven days. Each session includes approximately 45 minutes of instruction within a 60-minute school scheduling block for transitions and breaks. School-calendar disruptions may extend the calendar while preserving the planned sessions and sequence. Individual absences do not lead to individual makeup sessions or transfers; whole-group cancellations may be rescheduled for the same group.
Both CABVI conditions teach the same 36 concepts through shared reading, receptive and expressive vocabulary activities, movement and songs, and supported conversations. Bilingual CABVI uses Spanish in Sessions 1 and 3 of each unit and English in Sessions 2 and 4. English-only CABVI uses English throughout. Qualified school clinicians or appropriately trained and supervised study clinicians provide adult oversight. Usual-care services have no CABVI-matched research dose; weekly logs document actual frequency, duration, content and attendance. Required school and individualized education program services continue independently of participation.
Outcome assessments occur before intervention and allocation, during the school week after the final intervention session, and approximately six weeks after that session. English and Spanish are assessed on different days. The first assessment language is counterbalanced across children independently of intervention allocation, and each child's assigned order is preserved across timepoints. Both vocabulary blocks in the assigned first language precede the other language's blocks. Within each language, generalization, Naming and incidental expressive tasks precede Definition, Elaboration, target receptive and incidental receptive tasks. Narrative retells may be scheduled separately. All participant assessments and intervention procedures take place at participating schools. Masked assessors do not test children whose intervention they delivered or supervised and do not receive condition-revealing records. Compatible modules may be combined and visits divided for school scheduling, fatigue or willingness while preserving sequence and timing; no teaching or corrective feedback is provided during testing.
The four primary outcomes are binary Naming and Definition scores for the 36 directly taught concepts, separately in Spanish and English. Elaboration is a secondary picture-supported measure scoring 0-3 new distinct accurate target-related ideas per concept beyond all information in its preceding Definition exchange. Additional pre-specified outcomes include contextualized expressive generalization, target receptive recognition, exploratory expressive and receptive knowledge of 15 selected incidental concepts, and narrative mean length of utterance in words and number of different word roots, reported separately for Spanish- and English-elicited retells. The outcome plan combines the awarded R01 core with later prespecified measures selected for this study.
The implementation component anticipates 15 unique school-based SLPs or appropriately supervised SLPAs across five project years, targeting approximately 3 new clinicians per year with variation by eligible DLD caseloads. Each adult participates during one project year. Adult participants are distinct from hired research personnel and student clinicians and are not automatically randomized with the children. Data include independent fidelity observations, session completion and burden records, pre/post confidence, and post-implementation usability, satisfaction and feedback. Teacher and parent ratings address perceived child vocabulary use, communication confidence and engagement after intervention and at six-week follow-up where feasible. Analyses distinguish the randomized DLD comparison, the developmental comparison within bilingual CABVI, and implementation outcomes.
The same fixed assessment pictures are reused at pretest, immediate posttest and six-week follow-up. They differ from intervention pictures; they are not previously unseen at every assessment. The 15 incidental concepts are tiny, enormous, curious, bright, together, carefully, help, inside, clap, drag, last, whole, again, on and remember. They occur in instructional stories, elaborations, routines or directions outside the 36 direct targets. These are exploratory researcher-developed measures; psychometric validation of this exact assessment is not claimed. Independently score a planned 20% of outcomes and narrative transcripts where adequate permitted source records support it, retaining original ratings and adjudication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Parallel study of 120 Spanish-English bilingual children in kindergarten or first grade. After eligibility and baseline assessment, 80 children with developmental language disorder are randomized approximately 1:1:1 to bilingual CABVI, English-only CABVI, or usual English-language school services, using blocked allocation stratified by SLP/interventionist. Forty typically developing children receive bilingual CABVI without randomization as a developmental comparison. Children remain in their assigned condition. A separate implementation component evaluates fidelity, feasibility, confidence, usability and satisfaction among 15 anticipated unique school clinician participants across five project years, targeting approximately 3 new clinicians per year. Annual recruitment may vary with eligible DLD caseloads. Planned total enrollment is 135: 120 children and 15 clinicians.
| Arm | Type | Receives |
|---|---|---|
| Bilingual CABVI in children with DLD | Experimental | Behavioral: Bilingual computer-assisted vocabulary intervention (CABVI)Spanish-English bilingual children with developmental language disorder are randomized to bilingual CABVI. The computer-assisted behavioral vocabulary program teaches 36 concepts in 24 small-group sessions, ordinarily over about six weeks. Each session includes approximately 45 minutes of instruction within a 60-minute school block. Sessions 1 and 3 of each unit are in Spanish; Sessions 2 and 4 are in English. School-calendar disruptions may extend the schedule while preserving the planned sequence. |
| English-only CABVI in children with DLD | Active comparator | Behavioral: English-only computer-assisted vocabulary intervention (CABVI)Spanish-English bilingual children with developmental language disorder are randomized to English-only CABVI. This condition uses the same computer-assisted behavioral vocabulary content, 36 concepts, 24-session sequence, small-group format, and planned dose as bilingual CABVI, with all instruction delivered in English. Sessions include approximately 45 minutes of instruction within a 60-minute school block, ordinarily over about six weeks, with school-calendar extensions as needed. |
| Usual English-language school services in children with DLD | Active comparator | Behavioral: Usual English-language school servicesSpanish-English bilingual children with developmental language disorder are randomized to their usual English-language school services. A CABVI-matched research dose is not imposed. Weekly logs document actual service frequency, duration, content, and attendance. Required educational and individualized education program services continue independently of study participation. |
| Bilingual CABVI in typically developing children | Experimental | Behavioral: Bilingual computer-assisted vocabulary intervention (CABVI)Forty Spanish-English bilingual children with typical language development receive bilingual CABVI without randomization, providing a developmental comparison. They receive the same 36-concept, 24-session program and planned dose as the bilingual CABVI group with developmental language disorder. Sessions 1 and 3 of each unit are in Spanish; Sessions 2 and 4 are in English. Delivery is ordinarily completed over about six weeks, with school-calendar extensions as needed. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Age 5 years or older and enrolled in kindergarten or first grade at an authorized participating study site.
- Spanish-English emergent bilingual with regular Spanish exposure at home, including Spanish-primary or balanced bilingual homes, documented by parent questionnaire.
- Primary Test of Nonverbal Intelligence score of at least 70.
- Passes pure-tone hearing screening at 25 dB HL at 1000, 2000 and 4000 Hz.
- Names fewer than 12 of the 36 intervention target concepts before allocation, using the item-level bilingual conceptual union across complete Spanish and English Naming administrations. Count a concept once when an accepted label is produced in either language; 0-11 known concepts meets this vocabulary criterion, while 12-36 does not. Incomplete or unresolved administrations remain pending.
Key exclusion criteria (4 listed)
- Does not meet the inclusion criteria for the respective child or adult cohort.
- Comprehensive assessment does not support classification in the intended child study group.
- Adult clinician has participated in an earlier project year.
- Declining optional audio/video recording does not itself exclude participation.
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 |
|---|---|---|
| Bilingual computer-assisted vocabulary intervention (CABVI)Behavioral vocabulary intervention using the CABVI app with trained adult oversight in fixed groups of three to five children. Twenty-four planned sessions teach 36 concepts across six units. Each session includes approximately 45 minutes of instruction within a 60-minute school block. Spanish is used in Sessions 1 and 3 of each unit and English in Sessions 2 and 4. Activities include shared reading, receptive and expressive vocabulary practice, songs and movement, and supported conversations. Four sessions ordinarily occur within seven days, for about six weeks total; school-calendar disruptions may extend the schedule while preserving session sequence. | Behavioural | Bilingual CABVI in children with DLD, Bilingual CABVI in typically developing children |
| English-only computer-assisted vocabulary intervention (CABVI)Computer-assisted behavioral vocabulary intervention using the same 36 concepts, instructional content, 24-session sequence, fixed groups of three to five children, and planned dose as bilingual CABVI. All instruction is delivered in English. Sessions include approximately 45 minutes of instruction within a 60-minute school block, ordinarily four sessions within seven days over about six weeks. School-calendar disruptions may extend the schedule while preserving session sequence. Trained adults oversee the shared reading, receptive and expressive vocabulary activities, songs and movement, and supported conversations. | Behavioural | English-only CABVI in children with DLD |
| Usual English-language school servicesUsual English-language school services without a CABVI-matched research dose. Weekly logs document actual service frequency, duration, content, and attendance. Required educational and individualized education program services continue independently of study participation. | Behavioural | Usual English-language school services in children with DLD |
Primary outcome
Target vocabulary Naming in Spanish
Time frame: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
Researcher-developed picture Naming task for 36 directly taught concepts in Spanish. Images differ from intervention pictures and are reused across assessment timepoints. After any clearly other-language-only initial response, regardless of accuracy, give one fixed reminder to answer in Spanish, without translation or answer cues. An accepted requested-language label initially or after that reminder earns 1; incorrect, absent or other-language-only responses earn 0. Mixed responses containing an accepted requested-language label need no reminder. Record initial response, reminder and subsequent response separately; retain other-language conceptual knowledge separately. Complete-inventory total: 0-36; higher scores indicate greater requested-language Naming knowledge. Record actual denominators; refused, unadministered and uninterpretable items remain missing.
Target vocabulary Definition in Spanish
Time frame: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
Researcher-developed Definition task for 36 directly taught concepts in Spanish, without a picture. Supply the label and allow up to THREE TOTAL fixed neutral prompts: the initial meaning question and up to two neutral rephrasings. Continue only when no clearly accurate requested-language attribute, function or description has emerged and the child remains willing. Once binary credit is clear, stop extra prompting but let the child finish all volunteered information. No answer cues or correctness feedback. Accurate attribute, function or description: 1; incorrect, irrelevant, label-only or absent response after valid administration: 0. Preserve all prompts and responses for scoring and Elaboration exclusions. Complete-inventory total: 0-36; higher scores indicate greater semantic knowledge. Record actual denominators; refused, unadministered and uninterpretable items remain missing.
Target vocabulary Naming in English
Time frame: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
Researcher-developed picture Naming task for 36 directly taught concepts in English. Images differ from intervention pictures and are reused across assessment timepoints. After any clearly other-language-only initial response, regardless of accuracy, give one fixed reminder to answer in English, without translation or answer cues. An accepted requested-language label initially or after that reminder earns 1; incorrect, absent or other-language-only responses earn 0. Mixed responses containing an accepted requested-language label need no reminder. Record initial response, reminder and subsequent response separately; retain other-language conceptual knowledge separately. Complete-inventory total: 0-36; higher scores indicate greater requested-language Naming knowledge. Record actual denominators; refused, unadministered and uninterpretable items remain missing.
Target vocabulary Definition in English
Time frame: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
Researcher-developed Definition task for 36 directly taught concepts in English, without a picture. Supply the label and allow up to THREE TOTAL fixed neutral prompts: the initial meaning question and up to two neutral rephrasings. Continue only when no clearly accurate requested-language attribute, function or description has emerged and the child remains willing. Once binary credit is clear, stop extra prompting but let the child finish all volunteered information. No answer cues or correctness feedback. Accurate attribute, function or description: 1; incorrect, irrelevant, label-only or absent response after valid administration: 0. Preserve all prompts and responses for scoring and Elaboration exclusions. Complete-inventory total: 0-36; higher scores indicate greater semantic knowledge. Record actual denominators; refused, unadministered and uninterpretable items remain missing.
2 secondary outcomes
Target vocabulary Elaboration in Spanish
Time frame: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
Target vocabulary Elaboration in English
Time frame: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.
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 4 Nov 2026.
- Individual participant dataSharing planned: Yes. De-identified child participant data will be shared, including standardized assessment results, proximal assessment task results, intervention outcomes, and demographic information, with study documentation and analytic code. Data will be deposited in a controlled-access generalist repository participating in the NIH Generalist Repository Ecosystem Initiative. Supporting materials include the study protocol, data collection forms, manuals, and study-created assessments. Direct identifiers, the linkage key, and audio/video recordings will not be shared. Indirect identifiers will be reviewed to reduce re-identification risk. Sharing will follow the approved consent, data-sharing agreement, and institutional requirements.
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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.
Jean F Rivera Perez, PhD principal investigator
Texas Christian University
Questions about this trial
What is this clinical trial studying?
A study testing Bilingual computer-assisted vocabulary intervention (CABVI), English-only computer-assisted vocabulary intervention (CABVI) and Usual English-language school services in people with Developmental Language Disorder, run by Texas Christian University.
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 15 inclusion and 4 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Contact Jean F Rivera Perez, PhD, CCC-SLP (817-257-4075, j.riveraperez@tcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target vocabulary Naming in Spanish (time frame: Baseline before intervention and allocation; immediate posttest during the school week after the final intervention session; follow-up approximately six weeks after the final intervention session.). The study lists 4 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 4 Nov 2026.