Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
Same as current

Summary

Conditions
"Attention Deficit Hyperactivity Disorder"
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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...

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=8) as well as a new sample of parents who will have just completed CLS but who did not participate in the prior phases (N=8). Inclusion of these latter parents will allow for an assessment of the generalizability of the tool components to a new group of parents right after they complete in-person treatment. Parents will use their own device or will be provided with a study tablet. 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.

Tracking Information

NCT #
NCT04025814
Collaborators
Not Provided
Investigators
Principal Investigator: Linda Pfiffner, PhD University of California, San Francisco