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Interventions for English Language Learners At-Risk for ADHD

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily Report Card
Language Intervention
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring English Language Learners, Classroom Behavioral Intervention, Language Intervention

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Florida International UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Language Intervention

Daily Report Card

Combined Language and Daily Report Card

School As Usual

Arm Description

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.

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

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 22, 2023
Last Updated
June 23, 2023
Sponsor
Florida International University
Collaborators
Florida State University, Nova Southeastern University, University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT05918991
Brief Title
Interventions for English Language Learners At-Risk for ADHD
Official Title
Interventions for English Language Learners At-Risk for ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
July 30, 2026 (Anticipated)
Study Completion Date
July 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida International University
Collaborators
Florida State University, Nova Southeastern University, University of South Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
English Language Learners, Classroom Behavioral Intervention, Language Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Individuals completing classroom behavioral observations are masked to participant intervention assignment.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Language Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Daily Report Card
Arm Type
Experimental
Arm Description
The Daily Report Card group will receive the Daily Report Card intervention for 18 weeks.
Arm Title
Combined Language and Daily Report Card
Arm Type
Experimental
Arm Description
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.
Arm Title
School As Usual
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Daily Report Card
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Language Intervention
Other Intervention Name(s)
Dialogic Reading, Language in Motion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Expressive One-Word Picture Vocabulary Test 4th Edition (EOWPVT-4) Score
Description
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.
Time Frame
Post-treatment (i.e., after completion of the 18-week treatment phase)
Title
Word Classes 1 Subtest Score
Description
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.
Time Frame
Post-treatment (i.e., after completion of the 18-week treatment phase)
Title
Sentence Structure Subtest Score
Description
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.
Time Frame
Post-treatment (i.e., after completion of the 18-week treatment phase)
Title
Syntax Construction Subtest Score
Description
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.
Time Frame
Post-treatment (i.e., after completion of the 18-week treatment phase)
Title
Concepts and Following Directions Subtest Score
Description
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.
Time Frame
Post-treatment (i.e., after completion of the 18-week treatment phase)
Title
Oral Comprehension Subtest Score
Description
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.
Time Frame
Post-treatment (i.e., after completion of the 18-week treatment phase)
Title
Frequency counts of off-task behavior
Description
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.
Time Frame
Post-treatment (i.e., after completion of the 18-week treatment phase)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole K Schatz, PhD
Phone
305-348-0663
Email
nschatz@fiu.edu
Facility Information:
Facility Name
Florida International University
City
Miami
State/Province
Florida
ZIP/Postal Code
33199
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Schatz, PhD
Phone
305-348-0663
Email
nschatz@fiu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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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Interventions for English Language Learners At-Risk for ADHD

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