ClinicalTrials.gg
RecruitingNCT06456372Updated Jan 28, 2026

Digital Health Intervention for Children With ADHD

An interventional study of Digital Health Intervention Group in ADHD, sponsored by University of California, Riverside. Recruiting at 2 sites in United States. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-01-28.

Sponsored by University of California, Riverside · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
8 Years to 12 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 807 studies in Attention Deficit Disorder with Hyperactivity with a site in United States — 98 open to participants now, 116 under way, 5 of them phase 3. Attention Deficit Disorder with Hyperactivity · United States.

Planned enrollment
382nd of 706
60 · median 70
Started
2025
with 30 others
No phase
283 of 807
50 open now
Primary completion
2027-09
later than 67 of 115 live
Registered
723rd of 807
by date

Among the 807 studies in Attention Deficit Disorder with Hyperactivity with a site in United States, this one is the 382nd largest by planned enrollment of the 706 interventional ones that give a count, is one of 31 that started in 2025, is one of 283 with no phase, reaches primary completion later than 67 of the 115 other live ones, and was the 723rd registered.

Attention Deficit Disorder with Hyperactivity

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.

Browse Attention Deficit Disorder with Hyperactivity studies →

Open to participants now

98 of the 807 studies in Attention Deficit Disorder with Hyperactivity with a site in United States are open now. Recruiting first, the newest first:

93 more — sign in →

All 98 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 201 Attention Deficit Disorder with Hyperactivity studies recruiting now, 27 (13%) set no upper age limit and 169 (84%) stop at 75 or younger; 141 take children under 18; 55 take healthy volunteers.

This study: 8 Years to 12 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 807 studies in Attention Deficit Disorder with Hyperactivity with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Failure to meet any of the inclusion criteria
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • No intervention
    Treatment as Usual
  • Experimental
    Digital Health Intervention Group

    Behavioral: Digital Health Intervention Group

Interventions

  • BehavioralDigital 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 caregivers to share reliable and targeted information that will facilitate collaborative decision-making (e.g., making decisions about changing or titrating medications/dosages or shifting behavioral therapy and educational intervention targets) and improve patient experiences and outcomes.

06

What researchers measure

Primary outcomes

  1. Child Self-Regulation - BASC-3 SRP, PRS, TRS

    Behavior Assessment System for Children - BASC-3 Self, Parent, and Teacher reports - The Behavior Assessment System for Children - Third Edition is an individually-administered, norm-referenced, comprehensive set of rating scales and forms designed to inform understanding of the behaviors and emotions of children and adolescents ages 2 years through 21 years, 11 months. Forms available in this system include Parent Rating Scales (PRS), Teacher Rating Scales (TRS), the Self-Report of Personality (SRP; 6 years through 21 years, 11 months), and the Parenting Relationship Questionnaire (PRQ). The TRS/PRS rater responds to items about observed behaviors by answering N for Never, S for Sometimes, O for Often, or A for Almost always. The SRP respondent answers items about personal thoughts and feelings experienced. SRP items have one of two response formats: T for True or F for False; or N for Never, S for Sometimes, O for Often, or A for Almost always.

    Time frame: 1 Year

  2. ADHD Symptoms - BASC-3 SRP, PRS, TRS

    BASC-3 Self, Parent, and Teacher reports - The Behavior Assessment System for Children - Third Edition is an individually-administered, norm-referenced, comprehensive set of rating scales and forms designed to inform understanding of the behaviors and emotions of children and adolescents ages 2 years through 21 years, 11 months. Forms available in this system include Parent Rating Scales (PRS), Teacher Rating Scales (TRS), the Self-Report of Personality (SRP; 6 years through 21 years, 11 months), and the Parenting Relationship Questionnaire (PRQ). The TRS/PRS rater responds to items about observed behaviors by answering N for Never, S for Sometimes, O for Often, or A for Almost always. The SRP respondent answers items about personal thoughts and feelings experienced. SRP items have one of two response formats: T for True or F for False; or N for Never, S for Sometimes, O for Often, or A for Almost always.

    Time frame: 1 Year

  3. ADHD Symptoms - Brown EF/A

    Brown Executive Function/Attention Scales (Parent and Self Reports) - The Brown Scales screen and assess impairments of executive functioning (EF) and attention. They assess a wide range of symptoms of EF impairments associated with ADHD/ADD. These normed rating scales elicit parent and teacher report for children ages 3-12 yrs. For 8-12 year olds, a normed self-report version is also available. The scales are organized into six clusters of EF (i.e., Activation, Focus, Effort, Emotion, Memory, Action) with items tapping severity not frequency. This measure contains context-specific items (e.g., difficulty remembering what has been read when assigned), includes DSM-5-TR ADHD symptoms, and aspects of EF impairments not in the disorder's diagnostic criteria. They are designed to be completed by various respondents who have knowledge about an individual's daily behaviors and who have had extended and frequent opportunities to observe the individuals' responses to environmental demands.

    Time frame: 1 Year

  4. ADHD Symptoms - SWAN

    Strengths and Weakness of ADHD-symptoms \& Normal-behavior Scale (SWAN: Self, Parent, and Teacher reports) - SWAN screens for ADHD in youth \<18. It is completed by a parent/teacher \& has 18 questions that compare a child's attention skills to others of the same age group, family, \& school environment on skills like focusing attention, controlling anxiety, \& inhibiting impulsive behavior during tasks that require prolonged mental effort \& during daily activities. SWAN is based on observations of normal \& abnormal attention skills in different populations \& captures a range of behaviors. SWAN comprises 30 items measuring the full range of behavior, instead of only the pathological signs \& symptoms of ADHD \& measures behavioral characteristics representative of the attention skills of the general population. The seven-point response is scored from +3 to -3. Far below average = 3, below average = 2, slightly below average = 1; average = -1; above average = -2; \& far above average = -3.

    Time frame: 1 Year

  5. Parent Self-Regulation - BASC-3 PRQ

    BASC-3 Parenting Relationship Questionnaire (PRQ) - The BASC-3 PRQ is a measure of a parent's perspective on the parent's relationship with the child. It is standardized and normed and requires about 10-15 minutes for completion. It has 7 scales: Attachment, Communication, Discipline Practices, Involvement, Parenting Confidence, Satisfaction with School, Relational Frustration. Our primary focus will be on the Relational Frustration scale. Additional secondary analyses will be conducted to assess changes in parent behaviors. This scale can be administered remotely using Pearson's Q Global Remote Assessment Platform.

    Time frame: 1 Year

  6. Engagement in Care - PAM Child

    The Patient Activation Measure® (PAM) is a 10- or 13-item survey that assesses an individual's knowledge, skills and confidence integral to managing one's own health and healthcare. PAM segments individuals into one of four activation levels, providing insight into health-related characteristics like attitudes, motivators and behaviors. Each item has four response options: "disagree strongly," "disagree," "agree" and "agree strongly." The PAM has a theoretical range from 0 to 100. Higher scores indicate greater activation.

    Time frame: 1 Year

  7. Engagement in Care - PAM Parent

    Parent Patient Activation Measure (Parent PAM) - P-PAM was designed for use among caregivers of pediatric patients and requires parents to assess their knowledge, confidence, and willingness to act in regard to their child's health. The questionnaire aims to include a quantitative measure of all aspects of parent engagement on behalf of their child and also represents the individual level of engagement. Response options are on a four-point Likert scale ranging from (1) 'disagree strongly' to (4) 'agree strongly' or the option of (5) 'not applicable'. The total activation score was calculated on a continuous scale ranging from 0-100 and stratified into four levels of activation with higher scores corresponding to higher activation.

    Time frame: 1 Year

  8. Perceptions of Shared-Decision Making and Treatment Collaborations - Child & Parent

    Working Alliance Inventory-Short Revised - The Working Alliance Inventory-Short Revised is a 12-item validated scale that evaluates the working relationship between a client and a clinician. A sample item reads, "I believe the way we are working with my problem is correct" and has a rating from 1 (seldom) to 5 (always).

    Time frame: 1 Year

  9. Perceptions of Shared-Decision Making and Treatment Collaborations - Provider/Educator

    Working Alliance Inventory-Short Revised - The Working Alliance Inventory-Short Revised has a provider version of a 12-item validated scale that evaluates the working relationship between a client and a clinician. A sample item reads, "We are working on mutually agreed upon goals" and has a rating from 1 (seldom) to 5 (always). This scale has a version for other providers (e.g., physicians), which will be used for participants who are not providing mental health care to the child.

    Time frame: 1 Year

Secondary outcomes

  1. Self-Efficacy - BASC-3 SRP

    BASC-3 Self-Report - The Behavior Assessment System for Children - The Behavior Assessment System for Children - Third Edition is an individually-administered, norm-referenced, comprehensive set of rating scales and forms designed to inform understanding of the behaviors and emotions of children and adolescents ages 2 years through 21 years, 11 months. Forms available in this system include Parent Rating Scales (PRS), Teacher Rating Scales (TRS), the Self-Report of Personality (SRP; 6 years through 21 years, 11 months), and the Parenting Relationship Questionnaire (PRQ). The TRS/PRS rater responds to items about observed behaviors by answering N for Never, S for Sometimes, O for Often, or A for Almost always. The SRP respondent answers items about personal thoughts and feelings experienced. SRP items have one of two response formats: T for True or F for False; or N for Never, S for Sometimes, O for Often, or A for Almost always.

    Time frame: 1 Year

  2. Parent-Child Relationship - BASC-3 PRQ

    BASC-3 Parenting Relationship Questionnaire (PRQ) - The BASC-3 PRQ is a measure of a parent's perspective on the parent's relationship with the child. It is standardized and normed and requires about 10-15 minutes for completion. It has 7 scales: Attachment, Communication, Discipline Practices, Involvement, Parenting Confidence, Satisfaction with School, Relational Frustration. Our primary focus will be on the Relational Frustration scale. Additional secondary analyses will be conducted to assess changes in parent behaviors. This scale can be administered remotely using Pearson's Q Global Remote Assessment Platform.

    Time frame: 1 Year

  3. Parent-Child Relationship - BASC-3 SRP

    BASC-3 Self Report (Relations with Parent scale) - The Behavior Assessment System for Children - Third Edition is an individually-administered, norm-referenced, comprehensive set of rating scales and forms designed to inform understanding of the behaviors and emotions of children and adolescents ages 2 years through 21 years, 11 months. Forms available in this system include Parent Rating Scales (PRS), Teacher Rating Scales (TRS), the Self-Report of Personality (SRP; 6 years through 21 years, 11 months), and the Parenting Relationship Questionnaire (PRQ). The TRS/PRS rater responds to items about observed behaviors by answering N for Never, S for Sometimes, O for Often, or A for Almost always. The SRP respondent answers items about personal thoughts and feelings experienced. SRP items have one of two response formats: T for True or F for False; or N for Never, S for Sometimes, O for Often, or A for Almost always.

    Time frame: 1 Year

07

Study locations

2 of 2 sites recruiting
  • The Craig School
    Irvine, California 92612, United States
    Recruiting
  • UCR Psychiatry at Grindstaff Community School
    Riverside, California 92503, United States
    Recruiting
08

References and documents

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 '19 Adjunct). ACM, New York, NY, USA, 459-460. https://doi.org/10.1145/3341162.3345612.
  • 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.
  • 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. PubMed 34705845 ↗
  • 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.
  • 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.
  • Herrera N, Cibrian FL, Silva LM, Beltran JA, Schuck SEB, Hayes GR, Lakes KD. Digital health intervention for children with ADHD to improve mental health intervention, patient experiences, and outcomes: a study protocol. BMC Digit Health. 2024;2(1):78. doi: 10.1186/s44247-024-00134-4. Epub 2024 Nov 5. PubMed 39507592 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2025 (actual). Primary completion is estimated for Sep 2027, 31 months after the start.

Of 479 non-industry interventional studies with no phase under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 31 months is above that.

Counting every sponsor, half of 510 studies reached it within 23 months; a quarter within 11 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
May 20, 2024
First posted
Jun 13, 2024
StartActual
Feb 22, 2025
Primary completionEst.
Sep 29, 2027
CompletionEst.
Sep 29, 2027
Last update
Jan 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06456372
Lead sponsor
University of California, Riverside
Collaborators
University of California, Irvine, Chapman University
Responsible party
Sponsor
First posted
Jun 13, 2024
Start date
Feb 22, 2025
Primary completion
Sep 29, 2027 (estimated)
Completion
Sep 29, 2027 (estimated)
Last update
Jan 28, 2026

Study contacts

Jaime Smith
Contact
jaime.smith@medsch.ucr.edu
951-827-0741
Kimberley Lakes
Contact
kimberley.lakes@medsch.ucr.edu
951-827-2410

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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