Digital Health Intervention for Children With ADHD

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06456372
• Other study ID #: R21HS028871
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2024
• Est. completion date: September 29, 2027

Study information

• Verified date: June 2024
• Source: University of California, Riverside
• Contact: Jaime Smith
• Phone: 951-827-0741
• Email: jaime.smith[@]medsch.ucr.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 29, 2027
• Est. primary completion date: September 29, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

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 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Riverside	Chapman University, University of California, Irvine

References & Publications (11)

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 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. — View Citation

Cibrian, F. L., Hayes, G., & Lakes, K.D. (2020). Research Advances in ADHD and Technology. USA: Morgan & Claypool Publishers.

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.

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., 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

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.

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

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.

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.

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 Year
Primary	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.	1 Year
Primary	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.	1 Year
Primary	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.	1 Year
Primary	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.	1 Year
Primary	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.	1 Year
Primary	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.	1 Year
Primary	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).	1 Year
Primary	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.	1 Year
Secondary	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.	1 Year
Secondary	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.	1 Year
Secondary	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.	1 Year