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Attention Deficit Hyperactivity DisorderdHealthNCT04025814

dHealth Solution for Improving Parent Adherence to Behavioral Treatment for ADHD

A study testing CaregiverAssist and Behavioral Parent Training (CLS Parent Group) in people with Attention Deficit Hyperactivity Disorder, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Attention Deficit Hyperactivity Disorder
What is being tested?
CaregiverAssist and Behavioral Parent Training (CLS Parent Group)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteUnited States
Study dates
1 Aug 2020to 12 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • HALP Clinic, Children's Center at Langley Porter, UCSF

    San Francisco, California, 94143

Other trials in United States

About this study

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

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.

Read the 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=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.
  4. 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.
Being tested
CaregiverAssist, Behavioral Parent Training (CLS Parent Group)
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CaregiverAssistDevice

    CaregiverAssist is a proposed dHealth tool to promote parent adherence and sustained strategy use of evidence-based parenting strategies.

  • Behavioral Parent Training (CLS Parent Group)Behavioural

    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

Study groups in NCT04025814
Study groupRoleWhat they receive
dHealth tool and BPT GroupExperimentalParents 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.
Receives: Device: CaregiverAssist; Behavioral: Behavioral Parent Training (CLS Parent Group)
BPT GroupExperimentalParents 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.
Receives: Behavioral: Behavioral Parent Training (CLS Parent Group)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. System Usability Scale

    10-item sale for assessing technology product usability

    Measured: Change from baseline on technology usability at 6 months

  2. Feasibility Rating Scale

    1-5 Likert scale rating of amount of time and level of effort needed to use the tool regularly

    Measured: Change from baseline on technology use at 6 months

  3. Parent Acceptability and Satisfaction Questionnaire

    1-5 Likert scale rating level of engagement, usefulness, and acceptability

    Measured: Change from baseline on technology use at 6 months

  4. Parent adherence/implementation

    5-point Likert scale rating daily use of skills and behavior plans (tracked on application)

    Measured: Change from baseline on application use at 2 months

Secondary outcomes (7)
  1. Parent Confidence and Motivation to Use Evidence Based Parenting Skills

    5-point Likert scale of parent rated confidence and motivation

    Measured: Change from baseline on confidence and motivation at 2 months

  2. Parent Knowledge of Evidence Based Parenting Skills

    Assessed via content question, vignettes, and behavior plans to rate parent knowledge of EBT skills

    Measured: Change from baseline on knowledge of EBT at 2 months

  3. Alabama Parenting Questionnaire

    Assessment of parenting skills

    Measured: Change from baseline on parenting skills at 2 months

  4. Parenting Stress Index

    Assessment of parent stress

    Measured: Change from baseline on parent stress at 2 months

  5. 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.

    Measured: Change from baseline on parent executive functioning at 2 months

  6. Child and Adolescent Symptom Inventory (CASI-V)

    Assessment of ADHD and oppositional behaviors

    Measured: Change from baseline on ADHD and oppositional behaviors at 2 months

  7. Strengths and Difficulties Questionnaire

    Assessment of child impairments

    Measured: Change from baseline on child impairments at 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2019
  2. Study start1 Aug 2020
  3. Primary completion12 Nov 2024
  4. Study completion12 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04025814
Sponsor's protocol ID
19-28558
Acronym
dHealth
Status last verified
Jun 2025
First submitted
17 Jul 2019
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CaregiverAssist and Behavioral Parent Training (CLS Parent Group) in people with Attention Deficit Hyperactivity Disorder, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

System Usability Scale (time frame: Change from baseline on technology usability at 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.

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dHealth Clinical Trial NCT04025814 | AzTrials