Interventions for English Language Learners At-Risk for ADHD

NCT05918991 | Recruiting

• 1 other identifier: R324A210221
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

English Language Learners; Classroom Behavioral Intervention; Language Intervention

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  Post-treatment (i.e., after completion of the 18-week treatment phase)

Study Arms (4)

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.

Other: Language Intervention

Daily Report Card

EXPERIMENTAL

The Daily Report Card group will receive the Daily Report Card intervention for 18 weeks.

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.

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.

Interventions

Daily Report Card BEHAVIORAL

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.

Combined Language and Daily Report Card; Daily Report Card

Language Intervention OTHER

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.

Also known as: Dialogic Reading, Language in Motion

Combined Language and Daily Report Card; Language Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida International University: lead
• Florida State University: collaborator
• Nova Southeastern University: collaborator
• University of South Florida: collaborator

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Motion

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Physical Phenomena

Central Study Contacts

Nicole K Schatz, PhD

CONTACT

305-348-0663; nschatz@fiu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Individuals completing classroom behavioral observations are masked to participant intervention assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: June 26, 2023
• Study Start: May 18, 2022
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)