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.
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)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- 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
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:
- 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=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.
- 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- 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 group | Role | What they receive |
|---|---|---|
| dHealth tool and BPT Group | Experimental | Parents 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 Group | Experimental | Parents 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.
System Usability Scale
10-item sale for assessing technology product usability
Measured: Change from baseline on technology usability at 6 months
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
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
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)
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
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
Alabama Parenting Questionnaire
Assessment of parenting skills
Measured: Change from baseline on parenting skills at 2 months
Parenting Stress Index
Assessment of parent stress
Measured: Change from baseline on parent stress at 2 months
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
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
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.
- First posted19 Jul 2019
- Study start1 Aug 2020
- Primary completion12 Nov 2024
- Study completion12 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Pfiffner, PhD, Principal investigator, University of California, San Francisco
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Health Solution for Improving Parent Adherence to Behavioral Treatment for ADHD
- ClinicalTrials.gov ID
- NCT04025814
- Acronym / sponsor ID
- dHealth / 19-28558
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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=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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dHealth tool and BPT Group | Experimental | Device: CaregiverAssist, Behavioral: Behavioral Parent Training (CLS Parent Group)Parents 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. |
| BPT Group | Experimental | Behavioral: Behavioral Parent Training (CLS Parent Group)Parents 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. |
Who may qualify
- Ages
- 6 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaregiverAssistCaregiverAssist is a proposed dHealth tool to promote parent adherence and sustained strategy use of evidence-based parenting strategies. | Device | dHealth tool and BPT Group |
| Behavioral Parent Training (CLS Parent Group)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 | Behavioural | BPT Group, dHealth tool and BPT Group |
Primary outcome
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)
7 secondary outcomes
Parent Confidence and Motivation to Use Evidence Based Parenting Skills
Time frame: Change from baseline on confidence and motivation at 2 months
Parent Knowledge of Evidence Based Parenting Skills
Time frame: Change from baseline on knowledge of EBT at 2 months
Alabama Parenting Questionnaire
Time frame: Change from baseline on parenting skills at 2 months
Parenting Stress Index
Time frame: Change from baseline on parent stress at 2 months
Barkley Deficit in Executive Functions Scale
Time frame: Change from baseline on parent executive functioning at 2 months
Child and Adolescent Symptom Inventory (CASI-V)
Time frame: Change from baseline on ADHD and oppositional behaviors at 2 months
Strengths and Difficulties Questionnaire
Time frame: Change from baseline on child impairments at 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Pfiffner, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
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.