Attention Deficit Hyperactivity DisorderNCT05918991
Interventions for English Language Learners At-Risk for ADHD
A study testing Daily Report Card and Language Intervention in people with Attention Deficit Hyperactivity Disorder, run by Florida International University at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare the effect of language and behavioral interventions for students who are English language learners and who have symptoms of attention-deficit/hyperactivity disorder (ADHD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Daily Report Card and Language Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2022to 30 Jul 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Identified as an English Language Learner Level 1 through 4 by their school district
- Enrolled in kindergarten or 1st grade during the year of participation
- 6 or more symptoms of attention-deficit/hyperactivity disorder endorsed by parent or teacher
- Has a teacher who is willing to participate
- Has a parent or primary caregiver who is willing to participate
Who cannot join
- Participant has an active Individualized Education Plan for language or behavior
- Participant IQ is less than 70
- Participant is diagnosed with psychosis
- Participant is diagnosed with autism spectrum disorder with severity level 2 or greater or another pervasive developmental disorder
- Participant is enrolled in home-school
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
The goal of this clinical trial is to compare the effect of language and behavioral interventions for students who are English language learners and who have symptoms of attention-deficit/hyperactivity disorder (ADHD). The main question it aims to answer is:
- Which intervention is better for the students: the behavioral intervention, the language intervention, or a combination of the behavioral and language interventions?
Read more
Participants will be asked to do the following:
- Participants' parents and teachers will be asked to complete questionnaires about their behavior.
- Participants will be asked to complete tests assessing language, cognitive, and academic abilities.
- Members of the research team will complete classroom observations for the participating students.
- Participants will be randomly assigned to one of four groups: a school as usual group, a language group, a daily report card group, and a combined daily report card and language group.
- If assigned to the language group, participants will receive an 18-week language intervention.
- If assigned to the daily report card group, a behavioral consultant will work with participants' parents and teachers to set up a home-school behavior plan called a daily report card.
- If assigned to the combined daily report card and language group, participants will receive both the language intervention and the daily report card.
- If assigned to the school as usual group, participants will no study interventions.
Researchers will compare the language group, the daily report card group, the combined language and daily report card group, and the school as usual group to see which group has the best language learning and classroom behavior at the end of the program.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Daily Report Card, Language Intervention
- Keywords
- English Language Learners, Classroom Behavioral Intervention, Language Intervention
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Report CardBehavioural
Behavioral consultants will meet with teachers to review daily report card implementation and effective classroom management. The consultant collaborates with the teacher to identify specific behavioral goal targets for the student's DRC based on a review of teacher ratings and teacher description of key problem behaviors. After establishing the initial DRC, the consultant will review procedures with the teacher for scoring the DRC and, importantly, providing the student with effective and consistent performance feedback. The consultant will also make a plan with the teacher to review DRC progress and revise the DRC as needed. Consultants will also meet with parents to develop a plan for reinforcing the DRC at home. The DRC will be implemented for 18 weeks. The behavioral consultants will be available to teachers and parents throughout the duration of the intervention to assist with implementation and adjustment of target behaviors and goals.
Language InterventionOther
Also called Dialogic Reading, Language in Motion
The intervention protocol to be provided in each grade level will include 18 weeks of 20-25 minutes of small-group intervention 4 days per week, for a total of 72 lessons. The fifth day per week will be allocated to make-up lessons for students absent earlier in the week to maximize opportunity for each participant to receive the full dosage of lessons. Half of these lessons in each grade will be allocated to Language in Motion implementation and the other half to Dialogic Reading. Dialogic Reading is designed to increase vocabulary knowledge through shared reading of picture books. The content involves reading of 9 children's books with 108 targeted vocabulary words. Language in Motion is designed to increase syntax and grammar knowledge using science manipulatives. Daily lessons are highly scripted to introduce primary syntax targets through narrative text. Manipulation props are used to reinforce syntax targets and basic science topics.
| Study group | Role | What they receive |
|---|---|---|
| Language Intervention | Experimental | The language intervention will include 18 weeks of 20-25 minutes of intervention approximately 4 days per week. The language intervention is delivered via shared book reading and focuses on English language vocabulary development as well as development of syntax knowledge and expressive language. Receives: Other: Language Intervention |
| Daily Report Card | Experimental | The Daily Report Card group will receive the Daily Report Card intervention for 18 weeks. Receives: Behavioral: Daily Report Card |
| Combined Language and Daily Report Card | Experimental | Participants in this arm will receive a combination of the language intervention and the behavioral intervention. The interventions will be implemented simultaneously for 18 weeks. Receives: Behavioral: Daily Report Card; Other: Language Intervention |
| School As Usual | No intervention | Participants in the School as Usual Arm will receive neither the Behavioral Intervention nor the Language Intervention. There will be no restrictions, however, on interventions or supports that students may receive outside of the study either implemented through standard school protocol or accessed by parents. Thus, the School as Usual Arm provides a real-world practice comparison for the three active treatment groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expressive One-Word Picture Vocabulary Test 4th Edition (EOWPVT-4) Score
The EOWPVT-4 (Martin \& Brownell, 2011) consists of 190 items used to assess children's ability to verbally label illustrations of objects, actions, or concepts. Basal, based on child age, and ceiling (i.e., six consecutive incorrect responses) rules are used. Internal consistency (alpha) for ages 3-10 years ranges from .95 to .97, and split-half reliability, corrected for full length of the test, ranges from .96 to .98.
Measured: Post-treatment (i.e., after completion of the 18-week treatment phase)
Word Classes 1 Subtest Score
Clinical Evaluation of Language Fundamentals-4th Edition (CELF-4), Word Classes 1 Subtest. The Word Classes I subtest of the CELF-4 includes 21 (ages 5 to 7 years) items used to assess children's ability to recognize and identify words that share a semantic relationship. The examiner says three or four words (e.g., porcupine, quills, ball) and the child correctly responds by saying how two of the words are related (i.e., Porcupines have quills.). All children begin at the first item, and a ceiling is established after seven consecutive incorrect responses. Internal consistency (alpha) for ages 5-11 years ranges from.85 to .92.
Measured: Post-treatment (i.e., after completion of the 18-week treatment phase)
Sentence Structure Subtest Score
Clinical Evaluation of Language Fundamentals-4th Edition (CELF-4), Sentence Structure subtest. The CELF-4 Sentence Structure subtest consists of 26 items designed to assess the children's ability to comprehend spoken sentences of increasing length and syntactic complexity. Children listen to a sentence spoken by the examiner and select one picture out of four that illustrates the referential meaning of the sentence. All children begin at the first item and a ceiling is established after five consecutive incorrect responses. Internal consistency (alpha) for ages 5:0 - 8:11 years of age ranges from .64 to .76, and test-retest reliability for ages 6 - 7:11 years ranges from .67 to .74.
Measured: Post-treatment (i.e., after completion of the 18-week treatment phase)
Syntax Construction Subtest Score
Comprehensive Assessment of Spoken Language (CASL), Syntax Construction subtest. The Syntax Structure subtest of the CASL consists of 56 items used to assess the children's ability to formulate and express sentences using a variety of morphosyntactic rules. While showing the child a picture in the stimulus manual, the examiner either reads one to three sentences with a phrase missing from the final sentence (e.g., "This is a small fish. This is a ___." [big fish]) or gives the child a directive to say something related to the picture (e.g., "The man found the hat. Where was it?" [on the table]). Basal, based on child age, and ceiling (i.e., five consecutive incorrect responses) rules are used. Internal consistency (alpha) for ages 5-10 years ranges from .82 to .90, and test-retest reliability for ages 5-7 years is .79 and for ages 8-11 years is .74.
Measured: Post-treatment (i.e., after completion of the 18-week treatment phase)
Concepts and Following Directions Subtest Score
Clinical Evaluation of Language Fundamentals-4th Edition (CELF-4), Concepts and Following Directions subtest. The Concepts and Following Directions subtest of the CELF-4 consists of 54 items used to assess children's abilities to interpret and follow directions of increasing length and complexity (e.g., names, characteristics, and order of mention) using logical operations (e.g., before/after, tallest, etc.). Basal, based on child age, and ceiling (i.e., seven consecutive incorrect responses) rules are used. Internal consistency (alpha) ranges from .73 to .92, and test-retest reliability ranges from .67 to .88.
Measured: Post-treatment (i.e., after completion of the 18-week treatment phase)
Oral Comprehension Subtest Score
Woodcock-Johnson Tests of Achievement, 3rd Edition (WJ-III), Oral Comprehension subtest. The Oral Comprehension subtest of the WJ-III consists of 34 items that assess children's ability to comprehend short, audio-recorded or orally presented passages to complete an oral close task. The child hears a sentence followed by two beeps (for audio-recorded presentation) at which time the child provides a single word to finish the sentence. Basal, based on child grade, and ceiling (i.e., six consecutive items are responded to incorrectly) rules are used. Median internal consistency for children ages 5-19 years is .80, and one-year, test-retest reliability for children 4-7 years of age is .82.
Measured: Post-treatment (i.e., after completion of the 18-week treatment phase)
Frequency counts of off-task behavior
This outcome measure is collected via systematic direct observations of student classroom behavior by trained observers masked to treatment condition. The score is a frequency count of off-task behaviors during 30-minute observation periods. Because this is a count variable, the minimum value is zero and there is no maximum value. Higher scores indicate worse outcomes.
Measured: Post-treatment (i.e., after completion of the 18-week treatment phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start18 May 2022
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- Florida State University, Nova Southeastern University, University of South Florida
- Responsible party
- Principal investigator, Dr. Nicki Schatz, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918991
- Sponsor's protocol ID
- R324A210221
- Status last verified
- Aug 2026
- First submitted
- 22 Feb 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final data file will include (a) raw item-level data (where applicable to recreate analyses) with appropriate variable and value labels (b) all computed variables created during setup and scoring, and (c) all scale scores for the demographic, behavioral, and assessment or any other data used in a final analytic model.
Publications
Ramirez C, Schatz NK, Fernandez O, Phillips BM, Lonigan CJ, Fabiano GA, Gallo RF. Psychometric Evaluation of the Spanish Translation of the Disruptive-Behavior Disorder Rating Scale. J Atten Disord. 2026 Sep;30(9):1163-1177. doi: 10.1177/10870547261438171. Epub 2026 Apr 29.
PubMed 42052920
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions for English Language Learners At-Risk for ADHD
- ClinicalTrials.gov ID
- NCT05918991
- Acronym / sponsor ID
- R324A210221
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- English Language Learners, Classroom Behavioral Intervention, Language Intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- Florida State University, Nova Southeastern University, University of South Florida
- Study start
- 18 May 2022 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 26 Jun 2023 (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 goal of this clinical trial is to compare the effect of language and behavioral interventions for students who are English language learners and who have symptoms of attention-deficit/hyperactivity disorder (ADHD). The main question it aims to answer is:
- Which intervention is better for the students: the behavioral intervention, the language intervention, or a combination of the behavioral and language interventions?
Participants will be asked to do the following:
- Participants' parents and teachers will be asked to complete questionnaires about their behavior.
- Participants will be asked to complete tests assessing language, cognitive, and academic abilities.
- Members of the research team will complete classroom observations for the participating students.
- Participants will be randomly assigned to one of four groups: a school as usual group, a language group, a daily report card group, and a combined daily report card and language group.
- If assigned to the language group, participants will receive an 18-week language intervention.
- If assigned to the daily report card group, a behavioral consultant will work with participants' parents and teachers to set up a home-school behavior plan called a daily report card.
- If assigned to the combined daily report card and language group, participants will receive both the language intervention and the daily report card.
- If assigned to the school as usual group, participants will no study interventions.
Researchers will compare the language group, the daily report card group, the combined language and daily report card group, and the school as usual group to see which group has the best language learning and classroom behavior at the end of the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Language Intervention | Experimental | Other: Language InterventionThe language intervention will include 18 weeks of 20-25 minutes of intervention approximately 4 days per week. The language intervention is delivered via shared book reading and focuses on English language vocabulary development as well as development of syntax knowledge and expressive language. |
| Daily Report Card | Experimental | Behavioral: Daily Report CardThe Daily Report Card group will receive the Daily Report Card intervention for 18 weeks. |
| Combined Language and Daily Report Card | Experimental | Behavioral: Daily Report Card, Other: Language InterventionParticipants in this arm will receive a combination of the language intervention and the behavioral intervention. The interventions will be implemented simultaneously for 18 weeks. |
| School As Usual | No intervention | –Participants in the School as Usual Arm will receive neither the Behavioral Intervention nor the Language Intervention. There will be no restrictions, however, on interventions or supports that students may receive outside of the study either implemented through standard school protocol or accessed by parents. Thus, the School as Usual Arm provides a real-world practice comparison for the three active treatment groups. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Identified as an English Language Learner Level 1 through 4 by their school district
- Enrolled in kindergarten or 1st grade during the year of participation
- 6 or more symptoms of attention-deficit/hyperactivity disorder endorsed by parent or teacher
- Has a teacher who is willing to participate
- Has a parent or primary caregiver who is willing to participate
Key exclusion criteria (5 listed)
- Participant has an active Individualized Education Plan for language or behavior
- Participant IQ is less than 70
- Participant is diagnosed with psychosis
- Participant is diagnosed with autism spectrum disorder with severity level 2 or greater or another pervasive developmental disorder
- Participant is enrolled in home-school
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 |
|---|---|---|
| Daily Report CardBehavioral consultants will meet with teachers to review daily report card implementation and effective classroom management. The consultant collaborates with the teacher to identify specific behavioral goal targets for the student's DRC based on a review of teacher ratings and teacher description of key problem behaviors. After establishing the initial DRC, the consultant will review procedures with the teacher for scoring the DRC and, importantly, providing the student with effective and consistent performance feedback. The consultant will also make a plan with the teacher to review DRC progress and revise the DRC as needed. Consultants will also meet with parents to develop a plan for reinforcing the DRC at home. The DRC will be implemented for 18 weeks. The behavioral consultants will be available to teachers and parents throughout the duration of the intervention to assist with implementation and adjustment of target behaviors and goals. | Behavioural | Combined Language and Daily Report Card, Daily Report Card |
| Language InterventionAlso: Dialogic Reading, Language in MotionThe intervention protocol to be provided in each grade level will include 18 weeks of 20-25 minutes of small-group intervention 4 days per week, for a total of 72 lessons. The fifth day per week will be allocated to make-up lessons for students absent earlier in the week to maximize opportunity for each participant to receive the full dosage of lessons. Half of these lessons in each grade will be allocated to Language in Motion implementation and the other half to Dialogic Reading. Dialogic Reading is designed to increase vocabulary knowledge through shared reading of picture books. The content involves reading of 9 children's books with 108 targeted vocabulary words. Language in Motion is designed to increase syntax and grammar knowledge using science manipulatives. Daily lessons are highly scripted to introduce primary syntax targets through narrative text. Manipulation props are used to reinforce syntax targets and basic science topics. | Other | Combined Language and Daily Report Card, Language Intervention |
Primary outcome
Expressive One-Word Picture Vocabulary Test 4th Edition (EOWPVT-4) Score
Time frame: Post-treatment (i.e., after completion of the 18-week treatment phase)
The EOWPVT-4 (Martin \& Brownell, 2011) consists of 190 items used to assess children's ability to verbally label illustrations of objects, actions, or concepts. Basal, based on child age, and ceiling (i.e., six consecutive incorrect responses) rules are used. Internal consistency (alpha) for ages 3-10 years ranges from .95 to .97, and split-half reliability, corrected for full length of the test, ranges from .96 to .98.
Word Classes 1 Subtest Score
Time frame: Post-treatment (i.e., after completion of the 18-week treatment phase)
Clinical Evaluation of Language Fundamentals-4th Edition (CELF-4), Word Classes 1 Subtest. The Word Classes I subtest of the CELF-4 includes 21 (ages 5 to 7 years) items used to assess children's ability to recognize and identify words that share a semantic relationship. The examiner says three or four words (e.g., porcupine, quills, ball) and the child correctly responds by saying how two of the words are related (i.e., Porcupines have quills.). All children begin at the first item, and a ceiling is established after seven consecutive incorrect responses. Internal consistency (alpha) for ages 5-11 years ranges from.85 to .92.
Sentence Structure Subtest Score
Time frame: Post-treatment (i.e., after completion of the 18-week treatment phase)
Clinical Evaluation of Language Fundamentals-4th Edition (CELF-4), Sentence Structure subtest. The CELF-4 Sentence Structure subtest consists of 26 items designed to assess the children's ability to comprehend spoken sentences of increasing length and syntactic complexity. Children listen to a sentence spoken by the examiner and select one picture out of four that illustrates the referential meaning of the sentence. All children begin at the first item and a ceiling is established after five consecutive incorrect responses. Internal consistency (alpha) for ages 5:0 - 8:11 years of age ranges from .64 to .76, and test-retest reliability for ages 6 - 7:11 years ranges from .67 to .74.
Syntax Construction Subtest Score
Time frame: Post-treatment (i.e., after completion of the 18-week treatment phase)
Comprehensive Assessment of Spoken Language (CASL), Syntax Construction subtest. The Syntax Structure subtest of the CASL consists of 56 items used to assess the children's ability to formulate and express sentences using a variety of morphosyntactic rules. While showing the child a picture in the stimulus manual, the examiner either reads one to three sentences with a phrase missing from the final sentence (e.g., "This is a small fish. This is a ___." [big fish]) or gives the child a directive to say something related to the picture (e.g., "The man found the hat. Where was it?" [on the table]). Basal, based on child age, and ceiling (i.e., five consecutive incorrect responses) rules are used. Internal consistency (alpha) for ages 5-10 years ranges from .82 to .90, and test-retest reliability for ages 5-7 years is .79 and for ages 8-11 years is .74.
Concepts and Following Directions Subtest Score
Time frame: Post-treatment (i.e., after completion of the 18-week treatment phase)
Clinical Evaluation of Language Fundamentals-4th Edition (CELF-4), Concepts and Following Directions subtest. The Concepts and Following Directions subtest of the CELF-4 consists of 54 items used to assess children's abilities to interpret and follow directions of increasing length and complexity (e.g., names, characteristics, and order of mention) using logical operations (e.g., before/after, tallest, etc.). Basal, based on child age, and ceiling (i.e., seven consecutive incorrect responses) rules are used. Internal consistency (alpha) ranges from .73 to .92, and test-retest reliability ranges from .67 to .88.
Oral Comprehension Subtest Score
Time frame: Post-treatment (i.e., after completion of the 18-week treatment phase)
Woodcock-Johnson Tests of Achievement, 3rd Edition (WJ-III), Oral Comprehension subtest. The Oral Comprehension subtest of the WJ-III consists of 34 items that assess children's ability to comprehend short, audio-recorded or orally presented passages to complete an oral close task. The child hears a sentence followed by two beeps (for audio-recorded presentation) at which time the child provides a single word to finish the sentence. Basal, based on child grade, and ceiling (i.e., six consecutive items are responded to incorrectly) rules are used. Median internal consistency for children ages 5-19 years is .80, and one-year, test-retest reliability for children 4-7 years of age is .82.
Frequency counts of off-task behavior
Time frame: Post-treatment (i.e., after completion of the 18-week treatment phase)
This outcome measure is collected via systematic direct observations of student classroom behavior by trained observers masked to treatment condition. The score is a frequency count of off-task behaviors during 30-minute observation periods. Because this is a count variable, the minimum value is zero and there is no maximum value. Higher scores indicate worse outcomes.
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 20 Aug 2026.
- Derived from this study: PubMed 42052920Ramirez C, Schatz NK, Fernandez O, Phillips BM, Lonigan CJ, Fabiano GA, Gallo RF. Psychometric Evaluation of the Spanish Translation of the Disruptive-Behavior Disorder Rating Scale. J Atten Disord. 2026 Sep;30(9):1163-1177. doi: 10.1177/10870547261438171. Epub 2026 Apr 29.
- Individual participant dataSharing planned: Yes. The final data file will include (a) raw item-level data (where applicable to recreate analyses) with appropriate variable and value labels (b) all computed variables created during setup and scoring, and (c) all scale scores for the demographic, behavioral, and assessment or any other data used in a final analytic model.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Report Card and Language Intervention in people with Attention Deficit Hyperactivity Disorder, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
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?
Expressive One-Word Picture Vocabulary Test 4th Edition (EOWPVT-4) Score (time frame: Post-treatment (i.e., after completion of the 18-week treatment phase)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05918991, which also lists 1 linked publication.
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 20 Aug 2026.