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

Trial Summary

What is the purpose of this trial?

To conduct an RCT to evaluate the efficacy of the system, we will recruit 60 children (ages 8-12) with ADHD who will be randomized to either immediate (n=30) or delayed (n=30) treatment (i.e., a wait-list control group). Among those randomized to immediate treatment, half will be assigned to DHI (delivered via a smartwatch and smartphone application) and half will be assigned to an active control treatment as usual (TAU) group who will receive the smartwatch with no assigned activities, applications, or interventions on the devices. The intervention period will last 16 weeks; after a participant has been in the delayed treatment group for 16 weeks and has completed the post-waiting period assessment, he or she will be assigned to either the intervention or active control group. Thus, 30 participants will complete the intervention and 30 will complete the active control, with half of the total sample also completing a wait-list period.

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 data supports the effectiveness of the Digital Health Intervention treatment for ADHD?

Research suggests that digital health interventions can help improve symptoms of inattention, hyperactivity, and opposition in children and adolescents with ADHD by providing accessible and high-quality care. These interventions may also enhance medication adherence, which is crucial for managing ADHD effectively. ^{1 2 3 4 5}

Is the digital health intervention for ADHD safe for humans?

The safety of digital health interventions for ADHD is not fully detailed in the available research, but they are generally considered promising for mental health problems. However, specific safety data for these interventions is not provided in the reviewed articles. ^{1 2 6 7 8}

How is the Digital Health Intervention treatment for ADHD different from other treatments?

The Digital Health Intervention for ADHD is unique because it uses digital tools like apps and wearable technology to provide accessible and personalized care, which can be more appealing to children and adolescents who are already familiar with digital devices. This approach also involves the whole family in the treatment process, which can help address symptoms more effectively compared to traditional methods. ^{1 2 6 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Annual Research Review: Digital health interventions for children and young people with mental health problems - a systematic and meta-review. [2022]

2. Canada 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

What adults with ADHD want to know: A Delphi consensus study on the psychoeducational needs of experts by experience. [2022]

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

The impact of digital interventions on medication adherence in paediatric populations with attention deficit hyperactivity disorder, depression, and/or anxiety: A rapid systematic review and meta-analysis. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of digital health interventions in youth with chronic medical conditions: A meta-analysis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Editorial Perspective: Attention-deficit/hyperactivity disorder viewed as neuro-divergence in the digital world. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

European guidelines on managing adverse effects of medication for ADHD. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Attention-deficit/ hyperactivity disorder mobile apps: A systematic review. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Potential effectiveness of digital therapeutics specialized in executive functions as adjunctive treatment for clinical symptoms of attention-deficit/hyperactivity disorder: a feasibility study. [2023]