dHealth Solution for Improving Parent Adherence to Behavioral Treatment for ADHD

Study Overview
=================
Brief Summary
-----------------
This study aims to develop, refine and preliminarily test a novel and scalable digital health solution designed to address parent adherence barriers in daily life contexts and increase parent's sustained use of evidence-based parenting strategies.

Detailed Description
-----------------
The study includes the following 3 phases: Discovery phase: During the Discovery phase, we will conduct 1-hour focus groups at school sites with parents (N=8) and school mental health providers (N=4), who are considered major stakeholders and potential users of the dHealth tool. The purpose of these groups is to obtain feedback and guidance on features and procedures in order to maximize the usability and feasibility of the dHealth tool. This design includes participants who have completed a parenting skills treatment (CLS) and thus would be better informed to comment on needs for the augmented treatment. Stakeholders will be queried about their preferences regarding the application layout, tools, content, and features (e.g., reminders, badges). Recorded focus group sessions will be transcribed and coded for themes related to usability and feasibility. Design and Build phases: Feedback from the discovery phase will be incorporated into the design and build phases, during which time prototypes will be put through proof of concept testing with parents and school clinicians who had participated in the discovery phase. Qualitative data will be collected at 2 time points during the design and build phases. Quantitative data will be gathered using the System Usability Scale (SUS) for each component prototype (e.g., description of skill, video examples, interactive activities). A fully functioning application will be completed at the end of the build phase and ready for the test phase. Test Phase: The test phase is a 2-month pilot open trial of the dHealth tool with parents. We will provide the dHealth tool to parents who participated in the prior phases (N=5) as well as a new sample of parents (N=12) who will test the tool with their children in conjunction with the parent's participation in BPT at their school (to test tool utility during the course of treatment). Parents will be advised to use the tool daily to record parenting strategy use and to access information/training as needed. Qualitative semi-structured interviews during and after the trial will assess reactions to the platform (usability, feasibility, acceptability) to inform refinements and identify barriers and facilitators relating to use. Primary outcomes focus on usage metrics with the tool (e.g., frequency of use, module and activity completion, time, repeat activity), reported daily parenting skills use on the tool, and measures of feasibility and acceptability. Application usage analytics will be collected by the mobile application, providing objective descriptives including how often and for how long individuals access the application and each component, as well as how users navigate through the application. This data will be analyzed for patterns associated with tool satisfaction ratings, feasibility, and acceptability ratings and reported skill utilization. Secondary outcomes of parent knowledge, motivation and confidence in using EBT skills; parenting practices, ADHD symptoms and functional outcomes will be assessed before and after tool usage. Randomized Controlled Trial (RCT) Phase: The RCT phase is a 20-month pilot randomized controlled trial of the refined dHealth tool with parents. We will randomly assign groups to receive either the parenting skills training plus the tool (N=5 groups, 30 parents) or parenting skills training without the tool (N=5 groups, 30 parents). Exploratory analyses will examine the potential mediating mechanism of skill utilization (immediate and sustained) for optimizing the association between the dHealth intervention and improved child and parenting outcomes and the potential moderating effect of parent ADHD/EF functioning and internalizing mental health dimensions.

Official Title
-----------------
A Digital Health Solution for Improving Parent Adherence to Behavioral Treatment for ADHD

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Device: CaregiverAssist
* Behavioral: Behavioral Parent Training (CLS Parent Group)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child aged 6-11 (grades 1-5) Identification by school mental health professionals as experiencing challenges with inattention and/or hyperactivity/impulsivity Attending a participating SFUSD elementary school full time in a mainstream classroom Living with a caretaker who is available to participate in treatment Absence of significant visual/hearing impairment, severe language delay, psychosis, pervasive developmental disorder, or global intellectual impairment per school records Significant ADHD symptoms as evidenced by having (i) six or more symptoms of inattention and/or hyperactivity/impulsivity rated as occurring often or very often by parents, (ii) at least one area of functioning rated as -≥ 3 on the Impairment Rating Scale by parent Exclusion Criteria: No presence of conditions that are incompatible with this study's treatment including: severe visual or hearing impairment, severe language delay or intellectual impairment, psychosis, pervasive developmental disorder, Child is in an all-day special education classroom (children in these classrooms are frequently receiving intensive behavior modification programs such that the intervention would be expected to require modification for use in these settings) Children planning to change (start or stop) psychotropic medication Note: Children taking medication will be required to meet all entry criteria, including impairment criteria, thus indicating a need for the intervention. Children taking medication for attention or behavior are eligible as long as their medication regimens are stable.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dHealth tool and BPT Group<br>Parents and School Mental Health Providers (SMHPs) will participate in a 2-month trial during which they will use a digital Health (dHealth) tool in daily life contexts while receiving BPT, aimed to improve parent adherence sustained use of evidence-based parenting strategies. They will also participate in focus groups and discussions to facilitate the build, design, and use of the dHealth. | Device: CaregiverAssist<br>* CaregiverAssist is a proposed dHealth tool to promote parent adherence and sustained strategy use of evidence-based parenting strategies.<br>Behavioral: Behavioral Parent Training (CLS Parent Group)<br>* Collaborative Life Skills (CLS) program is implemented at school sites by school mental health providers who are trained by University of California San Francisco (UCSF) project staff<br>|
| Experimental: BPT Group<br>Parents and School Mental Health Providers (SMHPs) will participate in a 2-month trial during which they will be receiving BPT without the use of a digital Health (dHealth) tool. | Behavioral: Behavioral Parent Training (CLS Parent Group)<br>* Collaborative Life Skills (CLS) program is implemented at school sites by school mental health providers who are trained by University of California San Francisco (UCSF) project staff<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Usability Scale | 10-item sale for assessing technology product usability | Change from baseline on technology usability at 6 months | 
| Feasibility Rating Scale | 1-5 Likert scale rating of amount of time and level of effort needed to use the tool regularly | Change from baseline on technology use at 6 months | 
| Parent Acceptability and Satisfaction Questionnaire | 1-5 Likert scale rating level of engagement, usefulness, and acceptability | Change from baseline on technology use at 6 months | 
| Parent adherence/implementation | 5-point Likert scale rating daily use of skills and behavior plans (tracked on application) | Change from baseline on application use at 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent Confidence and Motivation to Use Evidence Based Parenting Skills | 5-point Likert scale of parent rated confidence and motivation | Change from baseline on confidence and motivation at 2 months | 
| Parent Knowledge of Evidence Based Parenting Skills | Assessed via content question, vignettes, and behavior plans to rate parent knowledge of EBT skills | Change from baseline on knowledge of EBT at 2 months | 
| Alabama Parenting Questionnaire | Assessment of parenting skills | Change from baseline on parenting skills at 2 months | 
| Parenting Stress Index | Assessment of parent stress | Change from baseline on parent stress at 2 months | 
| Barkley Deficit in Executive Functions Scale | We will use the Barkley Deficits in Executive Functioning Scale for Adults (BDEFS; Barkley, 2011) which is an empirically based tool for evaluating dimensions of adult executive functioning in daily life. We will use the Overall Executive Functioning Total Score which is a sum of all 89 items (each rated on a likert scale from 1 never or rarely to 4 very often such that higher scores represent greater degrees of executive functioning impairments) and possible values on the Total Score range from 89 to 356. | Change from baseline on parent executive functioning at 2 months | 
| Child and Adolescent Symptom Inventory (CASI-V) | Assessment of ADHD and oppositional behaviors | Change from baseline on ADHD and oppositional behaviors at 2 months | 
| Strengths and Difficulties Questionnaire | Assessment of child impairments | Change from baseline on child impairments at 2 months |