Digital Health Intervention for ADHD

Recruiting at 1 trial location

Overseen By Kimberley Lakes

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Riverside

Disqualifiers: Failure to meet inclusion criteria

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well a digital health intervention, delivered through a smartwatch and smartphone app, helps children with ADHD. It will compare this intervention to standard care, where participants use a smartwatch without special activities or apps. The trial seeks children aged 8 to 12 who have been diagnosed with ADHD and can use an app in English. Researchers will randomly assign participants to groups to either start treatment immediately or after a waiting period. The focus is on improving attention and behavior management in daily life. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance ADHD treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual treatment, as the trial includes a group that receives treatment as usual.

What prior data suggests that this digital health intervention is safe for children with ADHD?

Research has shown that digital health tools tested for children with ADHD have yielded promising results. Studies indicate these tools help reduce symptoms such as inattention and hyperactivity. Importantly, no major safety issues or harmful side effects emerged in these studies.

The research focused on children aged 6 to 12, the same age group as in this trial. Researchers found that digital tools are generally easy for kids to use without major problems. This makes digital health tools a safe option for managing ADHD symptoms in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Health Intervention for ADHD because it offers a fresh approach compared to traditional treatments like medication or behavioral therapy. Unlike standard medications, which often come with side effects or require regular doctor visits, this digital solution can be accessed remotely, making it more convenient and accessible for users. Additionally, it provides personalized feedback and progress tracking, which can help tailor the intervention to each individual's needs, potentially improving effectiveness and engagement. This tech-based approach aims to enhance self-management of ADHD symptoms, offering a new avenue for those looking for alternatives to conventional treatments.

What evidence suggests that this Digital Health Intervention is effective for ADHD?

Research shows that digital health tools can help reduce ADHD symptoms in children. In this trial, participants in the Digital Health Intervention Group will use these tools, which studies have found lead to a small but meaningful decrease in symptoms. For example, one study noted a reduction in symptoms, demonstrating noticeable improvement. Another study found similar results, indicating these tools helped improve attention-related symptoms. Overall, evidence suggests digital tools can be useful in managing ADHD symptoms in kids. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for children aged 8-12 with ADHD, who have been previously diagnosed and can use an app in English. They should have an IQ of at least 80 to ensure they can interact with the app effectively. A parent or guardian must be available to consent and provide feedback in English.

Inclusion Criteria

Reported IQ of at least 80 in order to ensure that the participant has the cognitive skills needed to use the app

DSM-5TR diagnosis of ADHD through prior medical or psychological evaluations at the time of admission to the program

Ability to complete questionnaires and use an app in English

Exclusion Criteria

Failure to meet any of the inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Digital Health Intervention (DHI) or Treatment as Usual (TAU) for 16 weeks

16 weeks

Wait-list Control

Participants in the delayed treatment group wait for 16 weeks before starting the intervention

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital Health Intervention

Trial Overview The study tests a Digital Health Intervention (DHI) delivered through a smartwatch and smartphone app against a control group receiving no intervention on their devices. Participants are randomly assigned to either start immediately or after a wait-list period, lasting 16 weeks each.

How Is the Trial Designed?

Group I: Digital Health Intervention Group Experimental Treatment 1 Intervention

Group II: Treatment as Usual Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, Riverside

Lead Sponsor

Trials

33

Recruited

14,400+

Chapman University

Collaborator

Trials

10

Recruited

920+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

Published Research Related to This Trial

A collaborative digital mental health intervention (DMHI) showed promising results in reducing symptoms of inattention and hyperactivity in children and adolescents with ADHD, with 71% of participants improving in inattention and 60% in hyperactivity after an average of 5.52 months of care.

The study found that longer duration of care was associated with greater reductions in symptom severity, indicating that ongoing support may enhance treatment outcomes for ADHD, although improvements in oppositional symptoms were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Digital Measurement-Based Care to Address Symptoms of Inattention, Hyperactivity, and Opposition in Youth: Retrospective Analysis of Bend Health. Lawrence-Sidebottom, D., Huffman, LG., Huberty, J., et al.[2023]

The safety profile of ADHD medications is not fully understood, with concerns about both older and newer medications potentially causing serious adverse effects, including sudden cardiac death and suicidality.

A review by the European Network for Hyperkinetic Disorders highlighted that while some adverse effects may be minimal or similar to risks in untreated individuals, further research is needed to clarify the safety risks associated with ADHD medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European guidelines on managing adverse effects of medication for ADHD. Graham, J., Banaschewski, T., Buitelaar, J., et al.[2022]

A systematic review identified 109 mobile apps designed for managing ADHD, targeting various users including children, adolescents, parents, and professionals, but very few provided evidence of their development or efficacy.

Despite the popularity of these apps, with some having up to 500,000 downloads, there is a significant lack of empirical support for their effectiveness, highlighting the need for further research to ensure their safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention-deficit/ hyperactivity disorder mobile apps: A systematic review. Păsărelu, CR., Andersson, G., Dobrean, A.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39191306/

The effect of digital interventions on attention deficit ... In the digital intervention groups, there was a significant decrease in overall ADHD symptoms (SMD = -0.33; 95 % CI = [-0.51, -0.16]) compared ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2451958825001186

Efficacy of digital mental health interventions for attention- ... Results showed small, significant effects of digital mental health interventions in reducing overall ADHD symptoms (g = −0.32, SE = 0.11, 95 % CI = [-0.53, − ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12016436/

Evaluating the evidence: a systematic review of ... Most of the reviews showed some evidence of positive outcomes associated with the use of digital interventions in ADHD populations. However, it ...

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 meta-analysis results showed that digital interventions improved the symptoms of inattention with an effect value of −0.20 (95% confidence ...

5. nature.com nature.com/articles/s41598-024-73934-3

Clinical study on the intervention effect of digital therapy ... To evaluate the efficacy and safety of digital therapy for children aged 6 to 12 years with attention deficit hyperactivity disorder (ADHD).

6. thelancet.com thelancet.com/journals/landig/article/PIIS2589-7500(20)30058-3/fulltext

Digital health interventions for children with ADHD Guideline on the clinical investigation of medicinal products for the treatment of attention decifit hyperactivity disorder (ADHD).

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032724013910

The effect of digital interventions on attention deficit ... The digital interventions proved beneficial for individuals with ADHD by alleviating symptoms of ADHD, inattention, and hyperactivity/impulsivity.