dHealth Solution for Improving Parent Adherence to Behavioral Treatment for ADHD (dHealth)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04025814|
Recruitment Status : Not yet recruiting
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Behavioral: CaregiverAssist||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Digital Health Solution for Improving Parent Adherence to Behavioral Treatment for ADHD|
|Estimated Study Start Date :||July 30, 2019|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Parents and School Mental Health Providers (SMHPs) will participate in focus groups and discussions to facilitate the build, design, and use of a digital Health (dHealth) tool to improve parent adherence sustained use of evidence-based parenting strategies. Parents will participate in a 2-month trial during which time they will use the dHealth tool in daily life contexts.
CaregiverAssist is a proposed dHealth tool to promote parent adherence and sustained strategy use of evidence-based parenting strategies.
- System Usability Scale [ Time Frame: Change from baseline on technology usability at 6 months ]10-item sale for assessing technology product usability
- Feasibility Rating Scale [ Time Frame: Change from baseline on technology use at 6 months ]1-5 Likert scale rating of amount of time and level of effort needed to use the tool regularly
- Parent Acceptability and Satisfaction Questionnaire [ Time Frame: Change from baseline on technology use at 6 months ]1-5 Likert scale rating level of engagement, usefulness, and acceptability
- Parent adherence/implementation [ Time Frame: Change from baseline on application use at 2 months ]5-point Likert scale rating daily use of skills and behavior plans (tracked on application)
- Parent Confidence and Motivation to Use Evidence Based Parenting Skills [ Time Frame: Change from baseline on confidence and motivation at 2 months ]5-point Likert scale of parent rated confidence and motivation
- Parent Knowledge of Evidence Based Parenting Skills [ Time Frame: Change from baseline on knowledge of EBT at 2 months ]Assessed via content question, vignettes, and behavior plans to rate parent knowledge of EBT skills
- Alabama Parenting Questionnaire [ Time Frame: Change from baseline on parenting skills at 2 months ]Assessment of parenting skills
- Parenting Stress Index [ Time Frame: Change from baseline on parent stress at 2 months ]Assessment of parent stress
- Barkley Deficit in Executive Functions Scale [ Time Frame: Change from baseline on parent executive functioning at 2 months ]Assessment of parent executive functioning
- Child and Adolescent Symptom Inventory (CASI-V) [ Time Frame: Change from baseline on ADHD and oppositional behaviors at 2 months ]Assessment of ADHD and oppositional behaviors
- Strengths and Difficulties Questionnaire [ Time Frame: Change from baseline on child impairments at 2 months ]Assessment of child impairments
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04025814
|Contact: Linda Pfiffner, PhDfirstname.lastname@example.org|
|Contact: Madeline Spiess, BAemail@example.com|
|United States, California|
|HALP Clinic, Children's Center at Langley Porter, UCSF||Not yet recruiting|
|San Francisco, California, United States, 94143|
|Contact: Linda Pfiffner, PhD 415-476-7418 firstname.lastname@example.org|
|Contact: Madeline Spiess, BA 415-476-7123 email@example.com|
|Principal Investigator: Linda Pfiffner, PhD|
|Principal Investigator:||Linda Pfiffner, PhD||University of California, San Francisco|