About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Failure to meet any of the inclusion criteria
Trial design
Crossover
Treatments tested in this trial
Digital Health Intervention Group
BehavioralOur 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
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.
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.
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.
Sponsors and contacts
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University of California, Riverside
Lead sponsor
University of California, Irvine
Collaborator
Chapman University
Collaborator