Technology-Enhanced Executive Functioning Intervention for ADHD

Not currently recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help adolescents with ADHD manage their homework and planning skills. Researchers are testing an online platform (digital health application) combined with a Homework Organization and Planning Skills (HOPS) intervention to determine if the digital tool enhances the intervention's effectiveness. Participants will receive either the HOPS sessions alone or the sessions plus access to the digital health tool. The study seeks adolescents aged 11 to 14 with ADHD-related challenges, particularly those facing attention or hyperactivity issues that impact their daily school life. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to experience this innovative approach.

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 prior data suggests that this online platform is safe for adolescents with ADHD?

Research has shown that the Homework Organization and Planning Skills (HOPS) program is safe and helps students with ADHD improve their organization and planning skills. Previous studies tested HOPS in schools and found that students generally handle it well, with no major negative effects reported.

For the digital health app, studies have demonstrated that online tools can assist children with ADHD. These digital tools are generally considered safe and have been used successfully elsewhere without major safety issues.

Both HOPS and the digital health app appear safe based on current research. However, since this trial is in its early stages, safety information is more limited, making ongoing monitoring important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Homework Organization and Planning Skills (HOPS) intervention for ADHD because it offers a unique approach by incorporating both traditional organizational/behavioral strategies and a digital health tool. Traditional ADHD treatments often rely on medication or behavioral therapy alone, but this intervention integrates an online application to potentially enhance the effectiveness of the skills being taught. The combination of face-to-face sessions with a digital component aims to improve executive functioning more effectively, providing a modern twist on helping individuals manage their symptoms.

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

Research shows that the Homework Organization and Planning Skills (HOPS) program helps children with ADHD improve their organizational skills. Studies have found that children who participated in HOPS made noticeable progress, according to both parents and teachers. School mental health experts have refined this program with feedback to better meet the needs of students with ADHD.

In this trial, one group of participants will receive the HOPS intervention alone, while another group will receive HOPS combined with a digital health app. Reviews of multiple studies suggest that digital tools can enhance behavior and thinking skills in children with ADHD. These findings support the idea that using HOPS along with a digital tool could help teenagers manage ADHD more effectively. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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

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.

I am an adolescent planning to change my mental health medication.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11534993/

Digital health intervention for children with ADHD to ...

CoolTaCo uses Patient-Centered Digital Healthcare Technologies (PC-DHT) to promote co-regulation (child/parent), capture patient data, support ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2451958825001186

Efficacy of digital mental health interventions for attention- ...

The current meta-analysis investigates the effectiveness of digital mental health interventions for ADHD synthesising data across 23 randomised controlled ...

3.

bmcdigitalhealth.biomedcentral.com

bmcdigitalhealth.biomedcentral.com/articles/10.1186/s44247-024-00129-1

findings from a survey and scoping review | BMC Digital Health

The aim of this mixed methods study is to explore the healthcare information preferences of people with lived experience of ADHD in the primary care context.

4.

frontiersin.org

frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2023.1054831/full

Meta-analysis of the efficacy of digital therapies in children ...

The aim of this meta-analysis was to summarize the available evidence for the efficacy of digital therapeutics in children and adolescents with ADHD.

5.

mental.jmir.org

mental.jmir.org/2023/1/e51459

Effectiveness of Technology-Based Interventions for School ...

Technology-based interventions are promising treatments for improving certain ADHD behaviors and cognitive functions among school-age children with ADHD.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11956344/

Developing an online educational platform to expedite ADHD ...

The platform substantially improved outcomes and has been fully implemented locally, highlighting the potential of digital healthcare in ...

7.

mdpi.com

mdpi.com/2504-2289/9/1/3

DETEC-ADHD: A Data-Driven Web App for Early ...

This study introduces DETEC-ADHD, a web-based application that combines machine learning (ML) techniques with multi-source data to enhance diagnostic accuracy.

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S138650561830323X

Attention-deficit/ hyperactivity disorder mobile apps

Data coming from a randomized controlled trial showed that an online intervention for parents of children with ADHD symptoms was effective in reducing child ...

9.

mental.jmir.org

mental.jmir.org/2025/1/e56066

A Narrative Review to Identify Promising Approaches for ...

We conclude that DHIs are a promising approach for emotion regulation interventions for adolescents with ADHD, could draw on a range of existing therapeutic ...