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dHealth Solution for Improving Parent Adherence to Behavioral Treatment for ADHD (dHealth)

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ClinicalTrials.gov Identifier: NCT04025814
Recruitment Status : Not yet recruiting
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Linda Pfiffner, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Behavioral: CaregiverAssist Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arm Intervention/treatment
Experimental: CaregiverAssist
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.
Behavioral: CaregiverAssist
CaregiverAssist is a proposed dHealth tool to promote parent adherence and sustained strategy use of evidence-based parenting strategies.




Primary Outcome Measures :
  1. System Usability Scale [ Time Frame: Change from baseline on technology usability at 6 months ]
    10-item sale for assessing technology product usability

  2. 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

  3. 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

  4. 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)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Alabama Parenting Questionnaire [ Time Frame: Change from baseline on parenting skills at 2 months ]
    Assessment of parenting skills

  4. Parenting Stress Index [ Time Frame: Change from baseline on parent stress at 2 months ]
    Assessment of parent stress

  5. Barkley Deficit in Executive Functions Scale [ Time Frame: Change from baseline on parent executive functioning at 2 months ]
    Assessment of parent executive functioning

  6. 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

  7. Strengths and Difficulties Questionnaire [ Time Frame: Change from baseline on child impairments at 2 months ]
    Assessment of child impairments



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Linda Pfiffner, PhD 415-476-7418 linda.pfiffner@ucsf.edu
Contact: Madeline Spiess, BA 415-476-7123 madeline.spiess@ucsf.edu

Locations
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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    linda.pfiffner@ucsf.edu   
Contact: Madeline Spiess, BA    415-476-7123    madeline.spiess@ucsf.edu   
Principal Investigator: Linda Pfiffner, PhD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Linda Pfiffner, PhD University of California, San Francisco

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Responsible Party: Linda Pfiffner, Ph.D., Professor in Residence, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04025814     History of Changes
Other Study ID Numbers: 19-28558
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders