Summary

for people ages 18 years and up (full criteria)
healthy people welcome
at San Francisco, California
study started
estimated completion
Linda Pfiffner, PhD

Description

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.

Official Title

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

Details

The study includes the following 3 phases:

  1. 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.
  2. 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.
  3. 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.

Keywords

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity CaregiverAssist

Eligibility

You can join if…

Open to people ages 18 years and up

-8 parents and 4 SMHPs who are participants in ongoing CLS-R open trials to participate in focus groups and usability testing of the dHealth tool.

(Parents were recruited for the CLS-R study based on study eligibility criteria for their children.)

**Eligibility criteria for children include:

  1. identification by school mental health professionals as experiencing challenges with inattention and/or hyperactivity/impulsivity
  2. aged 7-11 (grades 2-5)
  3. attending a participating SFUSD elementary school full time in a mainstream classroom
  4. living with a caretaker who is available to participate in treatment
  5. absence of significant visual/hearing impairment, severe language delay, psychosis, pervasive developmental disorder, or global intellectual impairment per school records
  6. 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 or teachers, with each informant endorsing at least two symptoms on the Child and Adolescent Symptom Inventory (ii) at least one area of functioning rated as -≥ 3 on the Impairment Rating Scale by both parent and teacher.

You CAN'T join if...

  • Parents and SMHPs who are not participating in ongoing CLS-R trials will be excluded from the study sample for Phase 1.
  • Parents who are not participants in ongoing CLS-R/CLS trial and who do not complete CLS-R/CLS by March 2020 will be excluded from the study sample for Phase 2.

Location

  • HALP Clinic, Children's Center at Langley Porter, UCSF not yet accepting patients
    San Francisco California 94143 United States

Lead Scientist

  • Linda Pfiffner, PhD
    Linda Pfiffner, PhD is a Professor in Residence and Director of the Hyperactivity, Attention and Learning Problems (HALP) Program in the Department of Psychiatry and is a licensed Clinical Psychologist. She received her B.A. from UCLA and her Ph.D. from the State University of New York at Stony Brook.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04025814
Study Type
Interventional
Last Updated