Behavioral & Language Interventions for ADHD

Overseen By Nicole K Schatz, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Florida International University

Disqualifiers: IEP, IQ less than 70, psychosis, autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 18 weeks

300 Participants Needed

Trial Summary

What is the purpose of 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.

Do I need to stop my current medications for this ADHD trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on behavioral and language interventions, so you might not need to change your medication routine.

What data supports the effectiveness of the treatment Behavioral & Language Interventions for ADHD?

Research shows that Daily Behavior Report Cards (DBRC), a component of the treatment, effectively reduce ADHD symptoms in classroom settings, with significant improvements observed in both teacher ratings and direct observations of student behavior. ^{1 2 3 4 5}

Is the Daily Report Card intervention safe for children with ADHD?

The Daily Report Card (DRC) intervention has been studied in school settings for children with ADHD and has shown positive effects on behavior without any reported safety concerns. It is generally considered safe for use in managing classroom behavior. ^{1 3 6 7 8}

How does the Daily Report Card and Language Intervention treatment for ADHD differ from other treatments?

This treatment is unique because it combines behavioral strategies like the Daily Report Card, which helps manage classroom behavior, with language interventions to support communication skills, making it a comprehensive approach for addressing both behavioral and language challenges in children with ADHD. ^{1 3 9 10 11}

Eligibility Criteria

This trial is for English language learners in kindergarten or 1st grade who show symptoms of ADHD. They must have a teacher and parent willing to participate, and be identified as Level 1-4 English Language Learners by their school.

Inclusion Criteria

Has a parent or primary caregiver who is willing to participate

I am in kindergarten or 1st grade this year.

My child's teacher or I have noticed 6 or more ADHD symptoms.

Exclusion Criteria

Participant has an active Individualized Education Plan for language or behavior

Participant IQ is less than 70

Participant is enrolled in home-school

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are 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. The treatment phase lasts for 18 weeks.

18 weeks

Approximately 4 visits per week for language intervention group

Follow-up

Participants are monitored for language learning and classroom behavior outcomes after the treatment phase.

4 weeks

Treatment Details

Interventions

• Daily Report Card
• Language Intervention

Trial Overview The study compares four approaches: usual school experience, an 18-week language intervention, a daily report card behavioral plan, and a combination of both interventions. Participants are randomly assigned to one group to see which method improves language learning and behavior.

Participant Groups

Group I: Language Intervention Experimental Treatment 1 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.

Group II: Daily Report Card Experimental Treatment 1 Intervention

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

Group III: Combined Language and Daily Report Card Experimental Treatment 2 Interventions

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.

Group IV: School As Usual Active Control 1 Intervention

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.

Daily Report Card is already approved in United States for the following indications:

Approved in United States as Daily Report Card for:

• Classroom behavior management for students with ADHD symptoms

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

Florida State University

Collaborator

Trials

234

Recruited

41,100+

Nova Southeastern University

Collaborator

Trials

103

Recruited

12,000+

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

Findings from Research

In a study of 66 children with ADHD or disruptive behavior problems, 72% showed significant improvement in target behaviors after implementing a daily report card (DRC) intervention, indicating its effectiveness in a general education setting.

Most children experienced a large benefit from the DRC within the first month, with continued improvements observed through Month 4, suggesting that the intervention can provide ongoing support for behavioral issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incremental benefits of a daily report card intervention over time for youth with disruptive behavior. Owens, JS., Holdaway, AS., Zoromski, AK., et al.[2012]

Most children treated in a day psychiatric hospital showed average or above-average progress in reading, spelling, and arithmetic over time, indicating effective educational support during treatment.

Organic impairment ratings were useful in differentiating performance levels among the children, suggesting that underlying conditions may influence academic achievement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Academic achievement of children with emotional disorders treated in a day hospital program: an outcome study. Zimet, SG., Farley, GK.[2019]

Daily Behavior Report Cards (DBRC) significantly reduce ADHD symptoms in classroom settings, with a moderate effect size of 0.36 based on a meta-analysis of 272 participants aged around 8 years.

Systematic direct observation of student behavior showed a larger effect size of 1.05, suggesting it may be a more sensitive measure of treatment effectiveness compared to teacher ratings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Daily Behavior Report Cards for Children With ADHD: A Meta-Analysis. Iznardo, M., Rogers, MA., Volpe, RJ., et al.[2021]

A short-term hospitalization program lasting four days effectively improved behavioral issues in 24 children, with 17 showing sustained improvement for up to 36 months after discharge.

Parents reported high satisfaction with the program, and standardized behavioral assessments indicated significant reductions in disturbed behavior and anxiety levels following the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term admission for behavior modification. Ramer, JC., Tinker, DE., Domoto, M.[2019]

In a study of 790 youth receiving intensive in-home services, treatment targets related to disruptive behavior and depressive mood showed significant improvement, reaching maximum gains in about three months.

Anxiety-related targets improved the fastest compared to disruptive behavior targets, highlighting the variability in treatment outcomes even within the same diagnostic group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency, level, and rate of improvement for treatment targets in a children's mental health community-based intensive in-home therapeutic setting. Love, AR., Mueller, CW., Tolman, RT., et al.[2019]

The study found that the Check-In/Check-Out (CICO) intervention significantly improved academic engagement and reduced disruptive behavior in four elementary students receiving Tier 2 behavioral supports.

Replacing teacher feedback with self-monitoring after the CICO intervention maintained the positive behavioral gains, suggesting that self-monitoring can be an effective strategy in school-based behavioral interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-monitoring as a viable fading option in check-in/check-out. Miller, LM., Dufrene, BA., Joe Olmi, D., et al.[2016]

The study involved 52 children with ADHD who were receiving medication, and it found that the self-help version of the New Forest Parenting Programme (NFPP-SH) improved parenting efficacy and child social performance when added to standard treatment.

While NFPP-SH showed benefits for parenting and social skills, it did not significantly change child behavior, suggesting that self-help interventions could be a low-cost complement to traditional therapies, but further research with larger groups is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a self-help parenting intervention for parents of children with attention deficit hyperactivity disorder in adjunct to usual treatment-Small-scale randomized controlled trial. Daley, D., Tarver, J., Sayal, K.[2021]

The review aims to systematically identify and evaluate non-pharmacological interventions for children aged 3-12 with ADHD, focusing on outcomes important to stakeholders, such as ADHD symptoms and quality of life.

The goal is to develop a flexible 'toolkit' of evidence-based strategies for school staff to improve the educational experience for children with ADHD, based on the effectiveness of identified intervention components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesising the existing evidence for non-pharmacological interventions targeting outcomes relevant to young people with ADHD in the school setting: systematic review protocol. Russell, AE., Moore, D., Sanders, A., et al.[2022]

School-based interventions for children with ADHD are expanding beyond the classroom to include non-classroom environments like lunchrooms and playgrounds, addressing both academic and behavioral challenges.

Combining psychosocial interventions with medication may enhance the effectiveness of treatment for ADHD, highlighting the importance of tailored strategies based on specific school contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial Interventions to Improve the School Performance of Students with Attention-Deficit/Hyperactivity Disorder. Tresco, KE., Lefler, EK., Power, TJ.[2021]

The CASH-AA protocol is a new family-based intervention designed to improve school performance in adolescents with ADHD by addressing home environment, adolescent skills, and family-school partnerships.

This intervention includes four modules focusing on psychoeducation, motivation, behavior change, and collaboration, making it adaptable for use alongside other treatments for ADHD or related disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing Academic Support in the Home for Adolescents with Attention-Deficit/Hyperactivity Disorder: A Family-Based Clinical Protocol for Improving School Performance. Hogue, A., Bobek, M., Evans, SW.[2021]

The HOPS intervention significantly improved organizational skills and homework completion behaviors in middle school students with ADHD, as reported by parents, with effect sizes indicating strong improvements (e.g., planning d = 1.05).

Despite these positive outcomes from parent ratings, teachers did not report significant improvements in the students' organizational skills, suggesting a discrepancy between home and school environments in the effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Homework, Organization, and Planning Skills (HOPS) Intervention for Middle School Students with ADHD as Implemented by School Mental Health Providers. Langberg, JM., Epstein, JN., Becker, SP., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Incremental benefits of a daily report card intervention over time for youth with disruptive behavior. [2012]

2. United States pubmed.ncbi.nlm.nih.gov

Academic achievement of children with emotional disorders treated in a day hospital program: an outcome study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The Effectiveness of Daily Behavior Report Cards for Children With ADHD: A Meta-Analysis. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Short-term admission for behavior modification. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Frequency, level, and rate of improvement for treatment targets in a children's mental health community-based intensive in-home therapeutic setting. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Self-monitoring as a viable fading option in check-in/check-out. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy of a self-help parenting intervention for parents of children with attention deficit hyperactivity disorder in adjunct to usual treatment-Small-scale randomized controlled trial. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Synthesising the existing evidence for non-pharmacological interventions targeting outcomes relevant to young people with ADHD in the school setting: systematic review protocol. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Psychosocial Interventions to Improve the School Performance of Students with Attention-Deficit/Hyperactivity Disorder. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Changing Academic Support in the Home for Adolescents with Attention-Deficit/Hyperactivity Disorder: A Family-Based Clinical Protocol for Improving School Performance. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Homework, Organization, and Planning Skills (HOPS) Intervention for Middle School Students with ADHD as Implemented by School Mental Health Providers. [2019]