Computer-Assisted Vocabulary Intervention for Spanish-English Bilingual Children With Developmental Language Disorder
NCT07915115, Not applicable, Not yet recruiting, Texas Christian University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Computer-Assisted Vocabulary Intervention for Spanish-English Bilingual Children With Developmental Language Disorder | ClinicalTrials.gov |
| NCT number | NCT07915115 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 135 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Texas Christian University | ClinicalTrials.gov |
| Conditions | Developmental Language Disorder | ClinicalTrials.gov |
| Interventions | Bilingual computer-assisted vocabulary intervention (CABVI), English-only computer-assisted vocabulary intervention (CABVI), Usual English-language school services | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Target vocabulary Naming in Spanish | 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. | ClinicalTrials.gov |
| Primary | Target vocabulary Definition in Spanish | 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. | ClinicalTrials.gov |
| Primary | Target vocabulary Naming in English | 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. | ClinicalTrials.gov |
| Primary | Target vocabulary Definition in English | 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. | ClinicalTrials.gov |
| Secondary | Target vocabulary Elaboration in Spanish | 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-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. | ClinicalTrials.gov |
| Secondary | Target vocabulary Elaboration in English | 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-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. | ClinicalTrials.gov |
| Other | Contextualized expressive generalization in Spanish | 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 task in Spanish using six scenes, one per unit, each depicting six target concepts in contexts different from intervention scenes. The SAME scenes are reused at pretest, posttest and follow-up; they are not previously unseen at every assessment. Administer first within each language, before Naming, target-label supply or receptive tasks. Per concept: 2 for spontaneous accurate requested-language target use; 1 for accurate use only after a logged permitted nonlexical continuation; 0 for absent or inaccurate use during valid administration. No target labels, pointing cues or teaching. Preserve initial and prompted responses separately. Complete-inventory total: 0-72 across 36 concepts; higher scores indicate more contextualized target use. Report languages separately, actual denominators and source limitations. Refused, unadministered and uninterpretable items remain missing. | ClinicalTrials.gov |
| Other | Target receptive recognition in Spanish | 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 receptive task in Spanish assessing 36 directly taught concepts. The examiner supplies the target label and presents a fixed four-image array. The first independent choice receives 1 point if correct and 0 if incorrect or no choice; no retries or corrective feedback are given. The complete-inventory raw total ranges from 0 to 36, with higher scores indicating greater receptive recognition. Actual item denominators and reasons for nonadministration are recorded; nonadministered items are missing, not zero. | ClinicalTrials.gov |
| Other | Incidental expressive vocabulary in Spanish | 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. | Exploratory researcher-developed expressive task in Spanish for the 15 selected incidental concepts encountered in instructional stories, elaborations, routines or directions outside the 36 directly taught targets. Fixed image/scene prompts do not supply or define the tested word. An appropriate requested-language selected word, phrase or accepted inflection earns 1; an incorrect or absent selected form after valid administration earns 0. Accurate paraphrases and other-language knowledge are retained separately as supplemental conceptual evidence, without replacing the word-production score. The same inventory, pictures, prompts and response keys are used across timepoints. Complete-inventory total: 0-15; higher scores indicate greater selected-word expressive knowledge. Report actual denominators; refused, unadministered and uninterpretable items remain missing. | ClinicalTrials.gov |
| Other | Incidental receptive vocabulary in Spanish | 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. | Exploratory researcher-developed receptive task in Spanish for the same 15 selected incidental concepts encountered in instructional stories, elaborations, routines or directions outside the 36 directly taught targets. After expressive tasks, supply the target label and show a fixed four-image array. Score the first deliberate independent choice: 1 correct; 0 incorrect or no choice after valid administration. No teaching, corrective feedback or child retries. Correct documented recording/motor errors with an audit trail. Use the same inventory, pictures, positions and response keys across timepoints. Complete-inventory total: 0-15; higher scores indicate greater receptive knowledge. Expressive and receptive scores remain separate. Report actual denominators; refused, unadministered and uninterpretable items remain missing. | ClinicalTrials.gov |
| Other | Contextualized expressive generalization in English | 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 task in English using six scenes, one per unit, each depicting six target concepts in contexts different from intervention scenes. The SAME scenes are reused at pretest, posttest and follow-up; they are not previously unseen at every assessment. Administer first within each language, before Naming, target-label supply or receptive tasks. Per concept: 2 for spontaneous accurate requested-language target use; 1 for accurate use only after a logged permitted nonlexical continuation; 0 for absent or inaccurate use during valid administration. No target labels, pointing cues or teaching. Preserve initial and prompted responses separately. Complete-inventory total: 0-72 across 36 concepts; higher scores indicate more contextualized target use. Report languages separately, actual denominators and source limitations. Refused, unadministered and uninterpretable items remain missing. | ClinicalTrials.gov |
| Other | Target receptive recognition in English | 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 receptive task in English assessing 36 directly taught concepts. The examiner supplies the target label and presents a fixed four-image array. The first independent choice receives 1 point if correct and 0 if incorrect or no choice; no retries or corrective feedback are given. The complete-inventory raw total ranges from 0 to 36, with higher scores indicating greater receptive recognition. Actual item denominators and reasons for nonadministration are recorded; nonadministered items are missing, not zero. | ClinicalTrials.gov |
| Other | Incidental expressive vocabulary in English | 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. | Exploratory researcher-developed expressive task in English for the 15 selected incidental concepts encountered in instructional stories, elaborations, routines or directions outside the 36 directly taught targets. Fixed image/scene prompts do not supply or define the tested word. An appropriate requested-language selected word, phrase or accepted inflection earns 1; an incorrect or absent selected form after valid administration earns 0. Accurate paraphrases and other-language knowledge are retained separately as supplemental conceptual evidence, without replacing the word-production score. The same inventory, pictures, prompts and response keys are used across timepoints. Complete-inventory total: 0-15; higher scores indicate greater selected-word expressive knowledge. Report actual denominators; refused, unadministered and uninterpretable items remain missing. | ClinicalTrials.gov |
| Other | Incidental receptive vocabulary in English | 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. | Exploratory researcher-developed receptive task in English for the same 15 selected incidental concepts encountered in instructional stories, elaborations, routines or directions outside the 36 directly taught targets. After expressive tasks, supply the target label and show a fixed four-image array. Score the first deliberate independent choice: 1 correct; 0 incorrect or no choice after valid administration. No teaching, corrective feedback or child retries. Correct documented recording/motor errors with an audit trail. Use the same inventory, pictures, positions and response keys across timepoints. Complete-inventory total: 0-15; higher scores indicate greater receptive knowledge. Expressive and receptive scores remain separate. Report actual denominators; refused, unadministered and uninterpretable items remain missing. | ClinicalTrials.gov |
| Other | CABVI implementation fidelity | During independently sampled sessions across the 24-session CABVI intervention, ordinarily about 6 weeks; school-calendar extensions are documented. | Observed session-level fidelity on the 10-criterion CABVI Fidelity Checklist, completed by a trained reviewer who did not deliver the session. Criteria are rated Y (delivered as planned), N (not delivered as planned), NO (not observable), or NA (not applicable). Fidelity is 100 x Y/(Y + N), ranging from 0% to 100%; higher percentages indicate greater delivery as planned. NO and NA are excluded from the denominator and reported separately; a zero denominator is not estimable. Observation method and denominator are reported. Independent review covers at least 20% of completed sessions per therapy group, rounded up (at least 5 of 24). Provider self-checks are separate and excluded from independent fidelity scores. No passing cutoff is assumed. | ClinicalTrials.gov |
| Other | Clinician confidence ratings for assigned vocabulary and research activities | Before implementation and at the post-implementation questionnaire after one intervention period (ordinarily about six weeks), within the clinician's single participation year. | Six researcher-developed items (C1-C6) assess confidence in supporting bilingual vocabulary within professional role; assigned activities when child and clinician languages differ; use of assigned materials and technology within the instructional plan; accurate clinical and research records; responding to breaks or unwillingness; and recognizing and obtaining needed help. Each item is rated separately: 1 Not at all confident, 2 Slightly, 3 Moderately, 4 Very, 5 Extremely confident. Higher ratings indicate greater confidence. The same items are given before and after implementation. For usual-care clinicians, assigned activities mean usual care and study documentation. Not applicable and Declined are recorded separately from numeric ratings. Item-level responses are retained; no summed or mean composite is specified. | ClinicalTrials.gov |
| Other | Clinician-reported implementation experience and satisfaction | At the post-implementation questionnaire after one intervention period (ordinarily about six weeks), within the clinician's single participation year. | Ten researcher-developed items (I1-I10) from the post-implementation clinician questionnaire assess preparation by training, clarity of instructions/materials, fit with the agreed school schedule, manageable documentation time, protection of required IEP services, access to help, child engagement, comfort with privacy/assent procedures, acceptability for children served, and overall satisfaction with study participation. Each item is rated separately: 1 Strongly disagree, 2 Disagree, 3 Neither agree nor disagree, 4 Agree, 5 Strongly agree. Higher ratings indicate greater agreement with the favorable statements. All participating clinicians may respond. Not applicable and Declined are recorded separately from numeric ratings. Item-level responses are retained; no summed or mean composite is specified. CABVI app items A1-A4 are reported separately. | ClinicalTrials.gov |
| Other | Clinician-reported CABVI app usability and acceptability | At the post-implementation questionnaire after one intervention period (ordinarily about six weeks), within the clinician's single participation year. | Four researcher-developed items (A1-A4) from the CABVI app block of the same post-implementation clinician questionnaire, completed only by CABVI providers, assess whether app audio models helped support assigned Spanish-language activities; usefulness of clinician controls and captions; manageability of technical interruptions with approved procedures and support; and willingness to consider future use if available and institutionally approved. Each item is rated separately: 1 Strongly disagree, 2 Disagree, 3 Neither agree nor disagree, 4 Agree, 5 Strongly agree. Higher ratings indicate greater agreement. Usual-care clinicians skip this block and are not asked to use or review CABVI. Not applicable and Declined are recorded separately. Item-level responses are retained; no summed or mean composite is specified. | ClinicalTrials.gov |
| Other | CABVI provider self-reported Spanish word or phrase learning | At the post-implementation questionnaire after one intervention period (ordinarily about six weeks), within the clinician's single participation year. | Researcher-developed item A5 asks CABVI providers whether they learned Spanish words or phrases while using CABVI. Responses are Yes, No, Unsure, Not applicable, or Declined and are retained as separate categorical responses; there is no numerical scale or total score. An optional nonidentifying general example may accompany the response. Usual-care clinicians skip this CABVI-only block. This is clinician self-report, not an objective Spanish proficiency test. | ClinicalTrials.gov |
| Other | Clinician-reported extra research time per week during implementation | At the post-implementation questionnaire after one intervention period (ordinarily about six weeks), within the clinician's single participation year. | Researcher-developed item W1 asks all adult clinician participants to report the approximate extra time per week spent on research activities during implementation, excluding ordinary school therapy. Responses are recorded in minutes per week. Higher numeric values indicate greater reported research time. Unsure and Declined responses are recorded separately from numeric time and are not scored as zero. The form specifies no upper numerical bound. This is a retrospective report of weekly research time, not a sum of ordinary therapy minutes or a daily time log. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01DC023613 | A Randomized Controlled Trial of Computer-Assisted Bilingual Vocabulary Intervention in Emergent Bilinguals with Developmental Language Disorder | Rivera Perez, Jean F | TEXAS CHRISTIAN UNIVERSITY | NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS | 2026 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Picture Naming Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)