Digital Health Intervention for Children With ADHD
NCT Number: NCT06456372
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: ADHD
Interventions: BEHAVIORAL: Digital Health Intervention Group
Sponsor: University of California, Riverside
Collaborators: University of California, Irvine|Chapman University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09-30
Completion Date: 2027-09-29

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.

Primary Outcome Measures: 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|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|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|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|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|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|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|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|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 Outcome Measures: 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|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|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