Interventions for English Language Learners At-Risk for ADHD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorFlorida International University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Daily Report Card
BehavioralBehavioral 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 Intervention
Other interventionThe 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.
Treatment groups
300 Participants
are divided into 4 treatment groupsGroup A: Language InterventionExperimental treatment 1 intervention
Group B: Daily Report CardExperimental treatment 1 intervention
Group C: Combined Language and Daily Report CardExperimental treatment 2 interventions
Group D: School As UsualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Post-treatment (i.e., after completion of the 18-week treatment phase)2
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.
Time frame
Post-treatment (i.e., after completion of the 18-week treatment phase)3
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.
Time frame
Post-treatment (i.e., after completion of the 18-week treatment phase)4
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.
Time frame
Post-treatment (i.e., after completion of the 18-week treatment phase)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Florida International University
Lead sponsor
Florida State University
Collaborator
Nova Southeastern University
Collaborator
University of South Florida
Collaborator
Source ClinicalTrials.gov