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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different interventions can help English language learners with ADHD symptoms improve language skills and classroom behavior. It compares a language-focused program, a behavior-focused program (using a daily report card system, also known as a Home-School Behavior Plan), and a combination of both, against typical school routines. Students in kindergarten or first grade who have ADHD symptoms and are learning English might be a good fit. Researchers will randomly assign participants to one of these groups for 18 weeks, tracking progress through questionnaires and classroom observations. The aim is to determine which intervention best supports these students. As an unphased trial, this study offers a unique opportunity to contribute to educational research and potentially enhance learning strategies for young students with ADHD symptoms.

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 prior data suggests that these interventions are safe for students with ADHD?

Research has shown that the Daily Report Card is a helpful tool for students with ADHD. It effectively reduces ADHD symptoms in the classroom and boosts school performance. Importantly, students have managed it well, with no serious side effects reported.

For the language intervention, less information exists on safety, but these activities are generally low-risk. They mainly involve structured activities like reading books together, which help with vocabulary and language skills.

Using both the Daily Report Card and the language activities together has not raised any new safety concerns. Combining these methods aims to improve both behavior and language development, with each having a good safety record.

Overall, these interventions aim to enhance behavior and language skills and are considered safe for students to try. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for ADHD because they offer new ways to support children beyond traditional medication and therapy. The Language Intervention focuses on improving vocabulary and language skills through engaging shared book reading, which is not typically a part of standard ADHD treatments. The Daily Report Card uses a behavioral approach by providing structured feedback and goals, helping children develop self-regulation skills in a practical setting. The combined approach of these two interventions could provide a more holistic strategy, addressing both language and behavior, which is a novel approach compared to standard treatments.

What evidence suggests that this trial's interventions could be effective for ADHD?

Research has shown that school-based language programs can enhance language skills and school performance in children with ADHD. About 30% of these children struggle with reading, so programs focusing on vocabulary and sentence structure can be beneficial. In this trial, some participants will receive the Language Intervention, which targets these areas.

Other participants will receive the Daily Report Card (DRC) method, which studies have found effective for improving behavior in children with ADHD. The DRC aids in developing skills needed to manage tasks, stay focused, and perform better in school.

Additionally, one treatment arm in this trial will provide participants with both the Language Intervention and the DRC simultaneously. Using language programs and the DRC together can effectively address both language and behavior issues, reducing ADHD symptoms and improving classroom behavior. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

Has a teacher who is willing to participate

I am in kindergarten or 1st grade this year.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

Citations

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2. psycnet.apa.org psycnet.apa.org/record/2026-35186-001

A randomized, controlled trial to evaluate the efficacy of a daily ... Objective: Daily report cards (DRC) are an effective approach for improving behavior in children with attention-deficit/hyperactivity disorder (ADHD).

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Daily Report Card Intervention and Attention Deficit ... The daily report card (DRC) is a commonly employed behavioral intervention for treating attention deficit hyperactivity disorder (ADHD) in schools.

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(PDF) The Effectiveness of Daily Behavior Report Cards for ... Conclusions: DBRCs effectively reduce the frequency and severity of ADHD symptoms in classroom settings. Additionally, they have a significant ...

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8. aquila.usm.edu aquila.usm.edu/cgi/viewcontent.cgi?article=3149&context=dissertations

Meta-Analysis of Daily Behavior Report Cards All participants were identified as at-risk, eligible for special education services, and/or having a disability, such as ADHD or emotional and behavioral ...