Technology-Enhanced Executive Functioning Intervention for ADHD

Overseen By Melissa R Dvorsky, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Children's National Research Institute

Must not be taking: Psychotropic medications

Disqualifiers: Autism, Bipolar, Psychotic, others

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

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is developing an online tool to help teenagers with ADHD improve their organizational skills. The tool uses fun activities and rewards to keep teens engaged, tracks their progress, and involves their families. It aims to make learning more effective and enjoyable for teens who struggle with traditional treatments.

Will I have to stop taking my current medications?

The trial requires that your medication regimen be stable, so you should not plan to start or stop any psychotropic medications (medications affecting the mind, emotions, and behavior) during the study.

What data supports the effectiveness of the treatment Digital Health Application (Online Platform) for Encouraging Skills Practice, Homework Organization and Planning Skills (HOPS) Intervention for ADHD?

Research shows that the HOPS intervention, which is part of the treatment, led to large improvements in organization skills and homework problems in students with ADHD, according to parent ratings. Additionally, working memory training, a component of executive function interventions, has been shown to reduce off-task behavior in children with ADHD. ^{1 2 3 4 5}

Is the Technology-Enhanced Executive Functioning Intervention for ADHD safe for humans?

The studies on the Homework, Organization, and Planning Skills (HOPS) intervention, which is part of the Technology-Enhanced Executive Functioning Intervention for ADHD, do not report any safety concerns or adverse effects, suggesting it is generally safe for use in humans. ^{1 2 3 6 7}

How is the HOPS treatment different from other ADHD treatments?

The HOPS treatment is unique because it focuses on improving executive functions like planning and organization, which are crucial for academic success in children with ADHD. Unlike other treatments that may target symptoms like inattention or hyperactivity, HOPS specifically aims to enhance skills needed for managing homework and school tasks. ^{4 5 8 9 10}

Eligibility Criteria

This trial is for adolescents aged 11-14 with ADHD, attending a participating school and showing significant symptoms and impairment. They must have parental consent, be referred by a school mental health provider, and not plan to change their psychotropic medication during the study.

Inclusion Criteria

I am between 11 and 14 years old and attend a participating school.

Parent consent and youth assent must be provided

A school mental health provider has referred a young person for apparent ADHD-related problems.

Exclusion Criteria

I can read and speak English, as required for participation.

You have been diagnosed with Autism Spectrum Disorder, Bipolar Disorder, Dissociative Disorder, severe visual or hearing impairment, severe language delay, intellectual impairment, or a Psychotic Disorder.

I am enrolled in all-day special education or core classes outside regular classrooms.

Timeline

Define

Focus groups with key stakeholders to develop the online platform

4 weeks

Refine

Extended formative usage evaluation to refine the online platform

8 weeks

Pilot

Open preliminary feasibility trial and usability testing of the online platform

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Digital Health Application (Online Platform) for Encouraging Skills Practice
• Homework Organization and Planning Skills (HOPS) Intervention

Trial Overview The study tests an online platform designed to help teens with ADHD improve organizational skills. It involves focus groups, usability testing, and a pilot randomized trial where some participants use this digital tool alongside traditional behavioral interventions.

Participant Groups

Group I: Organizational/behavioral intervention + digital health tool Experimental Treatment 2 Interventions

Participants will receive sixteen 30-minute sessions of the organizational/behavioral skills intervention (i.e., Homework Organization and Planning Skills \[HOPS\]) plus the online digital health application during treatment

Group II: Organizational/behavioral intervention only Active Control 1 Intervention

Participants will receive sixteen 30-minute sessions of the organizational/behavioral skills intervention (i.e., Homework Organization and Planning Skills \[HOPS\]) only, without the online digital health application during treatment

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Findings from Research

A study involving 280 middle school students with ADHD found that two brief school-based interventions, HOPS and CHIEF, significantly improved homework problems and organizational skills compared to a waitlist group, with large effect sizes.

The HOPS intervention was particularly effective for students with more severe ADHD symptoms, showing greater improvements in organized actions compared to CHIEF, suggesting that tailored interventions can enhance outcomes for students with varying levels of need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming the research-to-practice gap: A randomized trial with two brief homework and organization interventions for students with ADHD as implemented by school mental health providers. Langberg, JM., Dvorsky, MR., Molitor, SJ., et al.[2020]

The HOPS intervention led to significant improvements in organization skills (effect size d = 1.8) and homework management (d = 1.6) as reported by parents of 11 middle school students with ADHD, indicating its potential efficacy.

Despite positive parent feedback, teachers did not report similar improvements, highlighting a need for further refinement of the intervention to enhance its effectiveness in school settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refinement of an Organizational Skills Intervention for Adolescents with ADHD for Implementation by School Mental Health Providers. Langberg, JM., Vaughn, AJ., Williamson, P., et al.[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]

The HOPS intervention significantly improved organizational and planning skills in 23 middle school students with ADHD, as reported by parents, indicating its efficacy in addressing homework and organization problems.

The use of a structured binder organization system was a key predictor of success, showing that teaching students specific organizational skills can lead to better outcomes, independent of other factors like therapeutic alliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Response and Mechanisms of Change in an Organizational Skills Intervention for Students with ADHD. Langberg, JM., Becker, SP., Epstein, JN., et al.[2021]

References

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

Overcoming the research-to-practice gap: A randomized trial with two brief homework and organization interventions for students with ADHD as implemented by school mental health providers. [2020]

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

Refinement of an Organizational Skills Intervention for Adolescents with ADHD for Implementation by School Mental Health Providers. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of a computer-based neuropsychological training in children with attention-deficit hyperactivity disorder (ADHD). [2019]

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

Do programs designed to train working memory, other executive functions, and attention benefit children with ADHD? A meta-analytic review of cognitive, academic, and behavioral outcomes. [2018]

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

Will working memory training generalize to improve off-task behavior in children with attention-deficit/hyperactivity disorder? [2022]

6. 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]

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

Predictors of Response and Mechanisms of Change in an Organizational Skills Intervention for Students with ADHD. [2021]

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

What specific facets of executive function are associated with academic functioning in youth with attention-deficit/hyperactivity disorder? [2023]

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

A controlled trial of working memory training for children and adolescents with ADHD. [2022]

10. Austria pubmed.ncbi.nlm.nih.gov

Metacognitive executive function training for young children with ADHD: a proof-of-concept study. [2018]