Clinical trial NCT05918991: Interventions for English Language Learners At-Risk for ADHD
Official title: Interventions for English Language Learners At-Risk for ADHD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: English Language Learners
Classroom Behavioral Intervention
Language Intervention
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: Florida State University
name: Nova Southeastern University
name: University of South Florida
First posted: 2023-06-26
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Expressive One-Word Picture Vocabulary Test 4th Edition (EOWPVT-4) Score
timeFrame: Post-treatment (i.e., after completion of the 18-week treatment phase)
measure: Word Classes 1 Subtest Score
timeFrame: Post-treatment (i.e., after completion of the 18-week treatment phase)
measure: Sentence Structure Subtest Score
timeFrame: Post-treatment (i.e., after completion of the 18-week treatment phase)
measure: Syntax Construction Subtest Score
timeFrame: Post-treatment (i.e., after completion of the 18-week treatment phase)
measure: Concepts and Following Directions Subtest Score
timeFrame: Post-treatment (i.e., after completion of the 18-week treatment phase)
measure: Oral Comprehension Subtest Score
timeFrame: Post-treatment (i.e., after completion of the 18-week treatment phase)
measure: Frequency counts of off-task behavior
timeFrame: Post-treatment (i.e., after completion of the 18-week treatment phase)
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
References: