Interventions for English Language Learners At-Risk for ADHD

Florida International University (FIU)

Status: Enrolling

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Behavioral: Daily Report Card; Other: Language Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05918991

R324A210221

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

300 participants in 4 patient groups

Language Intervention

Experimental group

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.

Treatment:

Other: Language Intervention

Daily Report Card

Experimental group

Description:

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

Treatment:

Behavioral: Daily Report Card

Combined Language and Daily Report Card

Experimental group

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.

Treatment:

Other: Language Intervention

Behavioral: Daily Report Card

School As Usual

No Intervention group

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.