Digital Health Intervention for Children With ADHD

Official title

Digital Health Intervention for Children With ADHD: Improving Mental Health Intervention, Patient Experiences, and Outcomes

Overview

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.

Interventions

• Behavioral Digital Health Intervention Group
  Our digital health intervention (DHI) uses Patient-Centered Digital Healthcare Technologies (PC-DHT) to promote co-regulation (child/parent), capture patient data, support efficient healthcare delivery, enhance patient engagement, and facilitate shared decision-making, thereby improving access to timely and targeted mental health intervention for children at great risk for poor outcomes. This system will integrate treatment across multiple points of care and will enable health care providers and

Primary outcome measures

• Child Self-Regulation - BASC-3 SRP, PRS, TRS [Time frame: 1 Year]
• ADHD Symptoms - BASC-3 SRP, PRS, TRS [Time frame: 1 Year]
• ADHD Symptoms - Brown EF/A [Time frame: 1 Year]
• ADHD Symptoms - SWAN [Time frame: 1 Year]
• Parent Self-Regulation - BASC-3 PRQ [Time frame: 1 Year]
• Engagement in Care - PAM Child [Time frame: 1 Year]
• Engagement in Care - PAM Parent [Time frame: 1 Year]
• Perceptions of Shared-Decision Making and Treatment Collaborations - Child & Parent [Time frame: 1 Year]
• Perceptions of Shared-Decision Making and Treatment Collaborations - Provider/Educator [Time frame: 1 Year]

Secondary outcome measures (3)

• Self-Efficacy - BASC-3 SRP [Time frame: 1 Year]
• Parent-Child Relationship - BASC-3 PRQ [Time frame: 1 Year]
• Parent-Child Relationship - BASC-3 SRP [Time frame: 1 Year]

Eligibility criteria

Inclusion criteria

• 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,
• reported IQ of at least 80 in order to ensure that the participant has the cognitive skills needed to use the app, and
• parent/guardian available to consent and provide feedback in English.

Exclusion criteria

• Failure to meet any of the inclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 2 centers

• The Craig School — Irvine
• UCR Psychiatry at Grindstaff Community School — Riverside

Publications

• Cibrian, F., Cates, H., Guzman, K., Tavakoulnia, A., Shuck, S., Hayes, G., & Lakes, K.D. (2019). Should I wear a smartwatch? How children view wearables for behavior change. Workgroup on Interactive Systems in Healthcare, Chi'19.
• Cibrian, F. L., Lakes K.D., Schuck S, Tavakoulnia A, Guzman K, Hayes G. (2019). Balancing caregiver and child interactions to support the development of self-regulation skills using a smartwatch application. In Proceedings of the 2019 ACM International Joint Conference on Pervasive and Ubiquitous Computing and Proceedings of the 2019 ACM International Symposium on Wearable Computers (UbiComp/ISWC
• Tavakoulnia A, Guzman K, Cibrian, F. L., Lakes K.D., Hayes G., Schuck S. (2019). Designing a wearable technology application for enhancing executive function skills in children with ADHD. In Proceedings of UbiComp/ISWC'19. ACM, New York, NY, USA. https://doi.org/10.1145/3341162.3343819
• Cibrian, F., Lakes, K.D., Tavakoulnia, A., Guzman, K., Schuck, S. & Hayes, G., (2020). Supporting self-regulation of children with ADHD using wearables: Tensions and design challenges. ACM CHI2020. https://doi.org/10.1145/3313831.3376837
• Cibrian, F., Doan, M., Jang, A., Khare, N., Chang, S., Li, A., Schuck, S., Lakes, K.D., & Hayes, G.R.].(2020). CoolCraig: A smart watch/phone application supporting co-regulation of children with ADHD. ACM CHI2020, 1-7. https://doi.org/10.1145/3334480.3382991
• Ankrah, E., Cibrian, F.L., Beltran, J.A., Tavakoulnia A., Silva L., Schuck S., Lakes, K. D., Hayes G. (2020). How children with ADHD understand health data from smartwatches. Proceedings of the 2020 CHI Conference on Human Factors in Computing Systems.
• Cibrian, F. L., Hayes, G., & Lakes, K.D. (2020). Research Advances in ADHD and Technology. USA: Morgan & Claypool Publishers.
• Silva, L.M., Cibrian, F., Bhattacharya, A., Ankrah, E., Monteiro, E., Beltran, J., Schuck, S.E.B., Epstein, D., Lakes, K.D., & Hayes, G.R. (2021). Adapting multi-device deployments during a pandemic: Lessons learned from two studies. IEEE Pervasive Computing.

Identifiers

NCT: NCT06456372 · R21HS028871/R33HS028871 · R21HS028871

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗