Clinical trial NCT06456372: Digital Health Intervention for Children With ADHD
Official title: Digital Health Intervention for Children With ADHD: Improving Mental Health Intervention, Patient Experiences, and Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD
Lead sponsor: University of California, Riverside
Sponsor class: OTHER
Collaborators: name: University of California, Irvine
name: Chapman University
First posted: 2024-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. DSM-5TR diagnosis of ADHD through prior medical or psychological evaluations at the time of admission to the program,
2. ability to complete questionnaires and use an app in English,
3. reported IQ of at least 80 in order to ensure that the participant has the cognitive skills needed to use the app, and
4. parent/guardian available to consent and provide feedback in English.

Exclusion Criteria:

* Failure to meet any of the inclusion criteria

Primary outcomes:
measure: Child Self-Regulation - BASC-3 SRP, PRS, TRS
timeFrame: 1 Year
measure: ADHD Symptoms - BASC-3 SRP, PRS, TRS
timeFrame: 1 Year
measure: ADHD Symptoms - Brown EF/A
timeFrame: 1 Year
measure: ADHD Symptoms - SWAN
timeFrame: 1 Year
measure: Parent Self-Regulation - BASC-3 PRQ
timeFrame: 1 Year
measure: Engagement in Care - PAM Child
timeFrame: 1 Year
measure: Engagement in Care - PAM Parent
timeFrame: 1 Year
measure: Perceptions of Shared-Decision Making and Treatment Collaborations - Child & Parent
timeFrame: 1 Year
measure: Perceptions of Shared-Decision Making and Treatment Collaborations - Provider/Educator
timeFrame: 1 Year
Secondary outcomes:
measure: Self-Efficacy - BASC-3 SRP
timeFrame: 1 Year
measure: Parent-Child Relationship - BASC-3 PRQ
timeFrame: 1 Year
measure: Parent-Child Relationship - BASC-3 SRP
timeFrame: 1 Year
Other outcomes:
Locations:
city: Irvine
country: United States
facility: The Craig School
state: California
city: Riverside
country: United States
facility: UCR Psychiatry at Grindstaff Community School
state: California
Study officials:
References:
citation: 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.
citation: 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 '19 Adjunct). ACM, New York, NY, USA, 459-460. https://doi.org/10.1145/3341162.3345612.
citation: 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
citation: 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
citation: 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
citation: 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.
citation: Cibrian, F. L., Hayes, G., & Lakes, K.D. (2020). Research Advances in ADHD and Technology. USA: Morgan & Claypool Publishers.
citation: 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.
citation: Cibrian FL, Monteiro E, Ankrah E, Beltran JA, Tavakoulnia A, Schuck SEB, Hayes GR, Lakes KD. Parents' perspectives on a smartwatch intervention for children with ADHD: Rapid deployment and feasibility evaluation of a pilot intervention to support distance learning during COVID-19. PLoS One. 2021 Oct 27;16(10):e0258959. doi: 10.1371/journal.pone.0258959. eCollection 2021.
citation: Cibrian, F., Lakes, K.D., Schuck, S., & Hayes, G. (In Press). The potential impact of technologies supporting self-regulation in children with ADHD: A literature review. International Journal of Child-Computer Interaction.
citation: Lakes, K.D., Cibrian, F., Schuck, S., Nelson, M., & Hayes, G. (In Press). Digital health interventions for youth with ADHD: A mapping review. Computers in Human Behavior Reports.