Interventions for English Language Learners At-Risk for ADHD

Part of paid clinical trials in Miami, Florida.

Sponsor
Florida International University
Study ID
NCT05918991
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
May 18, 2022
Status verified
Aug 2025
Primary completion
Jul 30, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Language Intervention
    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.
  • Experimental: Daily Report Card
    The Daily Report Card group will receive the Daily Report Card intervention for 18 weeks.
  • Experimental: Combined Language and Daily Report Card
    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.
  • No Intervention: School As Usual
    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.

Primary Outcome Measure

Expressive One-Word Picture Vocabulary Test 4th Edition (EOWPVT-4) Score [ Time Frame: Post-treatment (i.e., after completion of the 18-week treatment phase) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Florida International UniversityMiamiFlorida33199
Nicole Schatz, PhD
305-348-0663

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