ADHDPhase 1NCT04729439
Technology-Enhanced Executive Functioning Intervention for ADHD
A Phase 1 study testing Homework Organization and Planning Skills (HOPS) Intervention and Digital Health Application (Online Platform) for Encouraging Skills Practice in people with ADHD and Attention Deficit Hyperactivity Disorder, run by Children's National Research Institute at 1 site in United States.
Trial summary
This study develops and refines an online platform that will support clinician-directed behavioral and organizational skills intervention for adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) with input guided from key stakeholders during focus groups and interviews (phase 1), extended usability testing… Read more about this study
- Who is it for?
- Ages 11 to 14 years
- Conditions the study is for
- ADHD, Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder
- What is being tested?
- Homework Organization and Planning Skills (HOPS) Intervention and Digital Health Application (Online Platform) for Encouraging Skills Practice
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2021to 14 Nov 2024
- Phase
- Phase 1
- 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 11 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Youth ages of 11 to 14 that are attending a participating school
- referred by school mental health provider as a youth with apparent ADHD-related problems
- ≥6 symptoms (item score ≥2) of Inattention or Hyperactivity-Impulsivity on the pooled parent and teacher Vanderbilt ADHD Rating Scale
- ≥3 on the Impairment Rating Scale by parent and teacher (cross-situational impairment)
- Parent consent and youth assent must be provided
Who cannot join
- No presence of conditions that are incompatible with this study's treatment including: Parent or adolescent report of a prior diagnosis of either Autism Spectrum Disorder, Bipolar Disorder, a Dissociative Disorder, Severe visual or hearing impairment, severe language delay or intellectual impairment, or a Psychotic Disorder will be excluded. Rationale: Individuals with these disorders often have very dysregulated behavior and impairments that deviate from the focus of this study.
- Adolescent is in all-day special education classes or if core classes not in regular education classrooms. Rationale: The vast majority of adolescent with ADHD are served in regular education classrooms and students in full-day self-contained classrooms often have different challenges than students in regular education.
- Adolescent planning to change (start or stop) psychotropic medication. Note: Adolescents taking medication will be required to meet all entry criteria, including impairment criteria, thus indicating a need for the intervention. Adolescent taking medication for attention or behavior are eligible as long as their medication regimens are stable. Participating parents will also need to be able to read/speak English because all measures are in English, and the intervention will be conducted in English.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's National Research Institute
Washington D.C., District of Columbia, 20010
Melissa R Dvorsky, Ph.D., 202-476-5000, ATOM@childrensnational.org
Melissa R Dvorsky, Ph.D.
About this study
Official title: Development of a Technology-Enhanced Executive Functioning Skills Intervention for Adolescents With ADHD
This study develops and refines an online platform that will support clinician-directed behavioral and organizational skills intervention for adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) with input guided from key stakeholders during focus groups and interviews (phase 1), extended usability testing (phase 2), and a pilot randomized trial (phase 3) of the online tool used in conjunction with an organizational skills intervention.
Read the detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most common childhood mental health disorders, affecting 7-9% of youth and leading to substantial impairment in adolescence. Despite evidence suggesting that behavioral interventions are efficacious, 41-60% of adolescents receiving behavioral treatment show little to no improvement and skills are rarely generalized beyond treatment sessions. Lack of adolescent motivation and engagement, between-session skills use, reward saliency, and family involvement are key contributors to these limited effects. Mobile digital health strategies and gamification techniques offer transformative opportunities for overcoming the barriers of evidence-based treatments specific to ADHD by using interactive tools to reinforce in-vivo skill practice, providing opportunities for immediate reinforcement, and motivating adolescents with digital rewards. The goal of this proposal is to develop and evaluate an online platform tool that will support clinician-directed behavioral treatment for adolescents with ADHD by improving executive functioning skills acquisition and utilization, providing in-vivo skills reinforcement, and monitoring adolescents' skill utilization. This study will use an empirically supported intervention specifically designed to address the domains of impairment frequently experienced by adolescents with ADHD. This study will use an iterative stakeholder-centered design to develop, refine, and preliminarily test a scalable digital health tool, applied as an adjunct to behavioral treatment for adolescents with ADHD. This includes focus groups with key stakeholders (Define), extended formative usage evaluation (Refine), and an open preliminary feasibility trial and usability testing (Pilot). Our goal is to develop and preliminary test an online platform that increases engagement, skills generalization, and family involvement in an empirically-supported organization skills intervention for adolescents with ADHD.
- Conditions
- ADHD, Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder, ADD, ADHD Predominantly Inattentive Type, ADHD - Combined Type
- Being tested
- Homework Organization and Planning Skills (HOPS) Intervention, Digital Health Application (Online Platform) for Encouraging Skills Practice
- Keywords
- ADHD, Attention-Deficit/Hyperactivity Disorder, Executive Functioning
- 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.
Homework Organization and Planning Skills (HOPS) InterventionBehavioural
A behavioral/organizational skills intervention focused on improving adolescents' homework, organization, and planning skills
Digital Health Application (Online Platform) for Encouraging Skills PracticeDevice
Also called Advanced Tools for Organization Management
This online platform can be used on participants' personal devices including laptops, phones, tablets, or other computers and is designed to encourage adolescent's skills practice, monitor and reward treatment progress, and optimize motivation in treatment
| Study group | Role | What they receive |
|---|---|---|
| Organizational/behavioral intervention + digital health tool | Experimental | Participants will receive sixteen 30-minute sessions of the organizational/behavioral skills intervention (i.e., Homework Organization and Planning Skills [HOPS]) plus the online digital health application during treatment Receives: Behavioral: Homework Organization and Planning Skills (HOPS) Intervention; Device: Digital Health Application (Online Platform) for Encouraging Skills Practice |
| Organizational/behavioral intervention only | Active comparator | Participants will receive sixteen 30-minute sessions of the organizational/behavioral skills intervention (i.e., Homework Organization and Planning Skills [HOPS]) only, without the online digital health application during treatment Receives: Behavioral: Homework Organization and Planning Skills (HOPS) Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vanderbilt ADHD Diagnostic Rating Scales (VADRS) Parent Version
The Vanderbilt scales are DSM-based with teacher- and parent-report forms (Wolraich et al., 1998, 2003). The 18 ADHD symptom items on the Vanderbilt have excellent internal consistency reliability, Cronbach's alpha >.90, and high concurrent validity with other instruments (see Wolraich et al., 2003). Items are rated from 0 (Never) to 3 (Very Often) and the total ADHD severity score range from 0 to 54 with higher scores representing presence of greater parent-rated symptom severity. The present study will examine change in ADHD symptom severity from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later), and 6-months post-intervention follow-up.
Measured: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
Vanderbilt ADHD Diagnostic Rating Scales (VADRS) Teacher Version
The Vanderbilt scales are DSM-based with teacher- and parent-report forms (Wolraich et al., 1998, 2003). The 18 ADHD symptom items on the Vanderbilt have excellent internal consistency reliability, Cronbach's alpha >.90, and high concurrent validity with other instruments (see Wolraich et al., 2003). Items are rated from 0 (Never) to 3 (Very Often) and the total ADHD severity score range from 0 to 54 with higher scores representing presence of greater parent-rated symptom severity. The present study will examine change in ADHD symptom severity from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later), and 6-months post-intervention follow-up.
Measured: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
Impairment Rating Scale (IRS) Parent Version
The IRS (7-items) was developed to assess the areas of functioning that typically characterize youth with ADHD and is effective in discriminating between youth with and without ADHD (Fabiano et al., 2006). All items are rated from 0 (No Problem) to 6 (Extreme Problem), with higher scores indicating higher levels parent-rated of functional impairment. The present study will examine change in functional impairment levels from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later), and 6-months post-intervention follow-up.
Measured: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
Impairment Rating Scale (IRS) Teacher Version
The IRS (7-items) was developed to assess the areas of functioning that typically characterize youth with ADHD and is effective in discriminating between youth with and without ADHD (Fabiano et al., 2006). All items are rated from 0 (No Problem) to 6 (Extreme Problem), with higher scores indicating higher levels teacher-rated of functional impairment. The present study will examine change in functional impairment levels from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later), and 6-months post-intervention follow-up.
Measured: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
System Usability Scale
10-item technology agnostic scale assessing technology product usability. The total SUS score ranges from 0 to 100, with higher scores indicating higher usability. SUS scores above 80 indicated good usability. The SUS has high internal consistency (α=.91) and high convergent validity with a separate rating of usability and user satisfaction (r=.8). The present study will assess change system usability at the end of software development (month 6), during the intervention trial (month 10), at post-treatment (month 12), and at 6-months post-intervention follow-up (month 18).
Measured: Month 6, Month 10, Month 12, Month 18
Secondary outcomes (3)
Barkley Deficits in Executive Functioning Scale (BDEFS-CA)
The BDEFS-CA (Barkley, 2012) is measure of children's daily life executive functioning normed on a representative sample of youth. The BDEFS-CA will be collected from parents and adolescents to evaluate the major components of executive functioning.
Measured: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
Behavioral Inhibition System/ Behavioral Activation System, BIS/BAS Scales
The BIS/BAS Scales (Carver \& White, 1994; Pagliaccio et al., 2016) is a 24-item (includes 4 filler items) self-report measure of reinforcement/reward sensitivity rated on a four-point scale to assess theoretical concepts of BIS and BAS function and their roles in motivation, behavior, and affect. Specifically, items on BAS assess pursuit of appetitive goals, reward responsivity, tendencies to seek new, potentially rewarding experiences, and tendencies to act quickly towards goals. Items assessing BIS sensitivity focus more narrowly on concerns about possible negative/punishing events and sensitivity to the occurrence of such events. Higher scores on the BIS and BASC scales indicate greater sensitivity to rewards and punishments. The present study will examine change in reward and reinforcement sensitivity from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later), and 6-months post-intervention follow-up.
Measured: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
Revised Child Anxiety and Depression Scales (RCADS)
The RCADS (Chorpita et al., 2005) is a 47-item measure (in the public domain) that assesses adolescent-report of DSM-based anxiety and depression symptoms. The RCADS has been validated for use with students in 3rd through 12th grade. The RCADS has excellent reliability and validity in clinical and school-based samples (Ebesutani et al., 2010). Items are rated from 0 (Never) to 3 (Always), with higher scores indicating higher levels of anxiety and depressive symptoms. The present study will examine change in anxiety and depressive symptom severity from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later), and 6-months post-intervention follow-up.
Measured: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start3 Feb 2021
- Primary completion14 Nov 2024 (estimated)
- Study completion14 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A preliminary feasibility effectiveness trial comparing two groups: (1) organizational/behavioral skills intervention augmented with digital health application and (2) organizational/behavioral skills intervention only
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Dvorsky, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729439
- Sponsor's protocol ID
- PRO#00014877
- Status last verified
- Feb 2023
- First submitted
- 25 Jan 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Technology-Enhanced Executive Functioning Skills Intervention for Adolescents With ADHD
- ClinicalTrials.gov ID
- NCT04729439
- Acronym / sponsor ID
- PRO#00014877
- Conditions
- ADHD, Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder, ADD, ADHD Predominantly Inattentive Type, ADHD - Combined Type
- Keywords
- ADHD, Attention-Deficit/Hyperactivity Disorder, Executive Functioning
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 14 Nov 2024 (estimated)
- Study completion
- 14 Nov 2024 (estimated)
- First posted
- 28 Jan 2021 (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 develops and refines an online platform that will support clinician-directed behavioral and organizational skills intervention for adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) with input guided from key stakeholders during focus groups and interviews (phase 1), extended usability testing (phase 2), and a pilot randomized trial (phase 3) of the online tool used in conjunction with an organizational skills intervention.
Detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most common childhood mental health disorders, affecting 7-9% of youth and leading to substantial impairment in adolescence. Despite evidence suggesting that behavioral interventions are efficacious, 41-60% of adolescents receiving behavioral treatment show little to no improvement and skills are rarely generalized beyond treatment sessions. Lack of adolescent motivation and engagement, between-session skills use, reward saliency, and family involvement are key contributors to these limited effects. Mobile digital health strategies and gamification techniques offer transformative opportunities for overcoming the barriers of evidence-based treatments specific to ADHD by using interactive tools to reinforce in-vivo skill practice, providing opportunities for immediate reinforcement, and motivating adolescents with digital rewards. The goal of this proposal is to develop and evaluate an online platform tool that will support clinician-directed behavioral treatment for adolescents with ADHD by improving executive functioning skills acquisition and utilization, providing in-vivo skills reinforcement, and monitoring adolescents' skill utilization. This study will use an empirically supported intervention specifically designed to address the domains of impairment frequently experienced by adolescents with ADHD. This study will use an iterative stakeholder-centered design to develop, refine, and preliminarily test a scalable digital health tool, applied as an adjunct to behavioral treatment for adolescents with ADHD. This includes focus groups with key stakeholders (Define), extended formative usage evaluation (Refine), and an open preliminary feasibility trial and usability testing (Pilot). Our goal is to develop and preliminary test an online platform that increases engagement, skills generalization, and family involvement in an empirically-supported organization skills intervention for adolescents with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A preliminary feasibility effectiveness trial comparing two groups: (1) organizational/behavioral skills intervention augmented with digital health application and (2) organizational/behavioral skills intervention only
| Arm | Type | Receives |
|---|---|---|
| Organizational/behavioral intervention + digital health tool | Experimental | Behavioral: Homework Organization and Planning Skills (HOPS) Intervention, Device: Digital Health Application (Online Platform) for Encouraging Skills PracticeParticipants will receive sixteen 30-minute sessions of the organizational/behavioral skills intervention (i.e., Homework Organization and Planning Skills [HOPS]) plus the online digital health application during treatment |
| Organizational/behavioral intervention only | Active comparator | Behavioral: Homework Organization and Planning Skills (HOPS) InterventionParticipants will receive sixteen 30-minute sessions of the organizational/behavioral skills intervention (i.e., Homework Organization and Planning Skills [HOPS]) only, without the online digital health application during treatment |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Youth ages of 11 to 14 that are attending a participating school
- referred by school mental health provider as a youth with apparent ADHD-related problems
- ≥6 symptoms (item score ≥2) of Inattention or Hyperactivity-Impulsivity on the pooled parent and teacher Vanderbilt ADHD Rating Scale
- ≥3 on the Impairment Rating Scale by parent and teacher (cross-situational impairment)
- Parent consent and youth assent must be provided
Key exclusion criteria (3 listed)
- No presence of conditions that are incompatible with this study's treatment including: Parent or adolescent report of a prior diagnosis of either Autism Spectrum Disorder, Bipolar Disorder, a Dissociative Disorder, Severe visual or hearing impairment, severe language delay or intellectual impairment, or a Psychotic Disorder will be excluded. Rationale: Individuals with these disorders often have very dysregulated behavior and impairments that deviate from the focus of this study.
- Adolescent is in all-day special education classes or if core classes not in regular education classrooms. Rationale: The vast majority of adolescent with ADHD are served in regular education classrooms and students in full-day self-contained classrooms often have different challenges than students in regular education.
- Adolescent planning to change (start or stop) psychotropic medication. Note: Adolescents taking medication will be required to meet all entry criteria, including impairment criteria, thus indicating a need for the intervention. Adolescent taking medication for attention or behavior are eligible as long as their medication regimens are stable. Participating parents will also need to be able to read/speak English because all measures are in English, and the intervention will be conducted in English.
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 |
|---|---|---|
| Homework Organization and Planning Skills (HOPS) InterventionA behavioral/organizational skills intervention focused on improving adolescents' homework, organization, and planning skills | Behavioural | Organizational/behavioral intervention + digital health tool, Organizational/behavioral intervention only |
| Digital Health Application (Online Platform) for Encouraging Skills PracticeAlso: Advanced Tools for Organization ManagementThis online platform can be used on participants' personal devices including laptops, phones, tablets, or other computers and is designed to encourage adolescent's skills practice, monitor and reward treatment progress, and optimize motivation in treatment | Device | Organizational/behavioral intervention + digital health tool |
Primary outcome
Vanderbilt ADHD Diagnostic Rating Scales (VADRS) Parent Version
Time frame: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
The Vanderbilt scales are DSM-based with teacher- and parent-report forms (Wolraich et al., 1998, 2003). The 18 ADHD symptom items on the Vanderbilt have excellent internal consistency reliability, Cronbach's alpha >.90, and high concurrent validity with other instruments (see Wolraich et al., 2003). Items are rated from 0 (Never) to 3 (Very Often) and the total ADHD severity score range from 0 to 54 with higher scores representing presence of greater parent-rated symptom severity. The present study will examine change in ADHD symptom severity from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later), and 6-months post-intervention follow-up.
Vanderbilt ADHD Diagnostic Rating Scales (VADRS) Teacher Version
Time frame: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
The Vanderbilt scales are DSM-based with teacher- and parent-report forms (Wolraich et al., 1998, 2003). The 18 ADHD symptom items on the Vanderbilt have excellent internal consistency reliability, Cronbach's alpha >.90, and high concurrent validity with other instruments (see Wolraich et al., 2003). Items are rated from 0 (Never) to 3 (Very Often) and the total ADHD severity score range from 0 to 54 with higher scores representing presence of greater parent-rated symptom severity. The present study will examine change in ADHD symptom severity from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later), and 6-months post-intervention follow-up.
Impairment Rating Scale (IRS) Parent Version
Time frame: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
The IRS (7-items) was developed to assess the areas of functioning that typically characterize youth with ADHD and is effective in discriminating between youth with and without ADHD (Fabiano et al., 2006). All items are rated from 0 (No Problem) to 6 (Extreme Problem), with higher scores indicating higher levels parent-rated of functional impairment. The present study will examine change in functional impairment levels from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later), and 6-months post-intervention follow-up.
Impairment Rating Scale (IRS) Teacher Version
Time frame: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
The IRS (7-items) was developed to assess the areas of functioning that typically characterize youth with ADHD and is effective in discriminating between youth with and without ADHD (Fabiano et al., 2006). All items are rated from 0 (No Problem) to 6 (Extreme Problem), with higher scores indicating higher levels teacher-rated of functional impairment. The present study will examine change in functional impairment levels from baseline/pre-intervention (month 0) to post intervention (up to 12 weeks later), and 6-months post-intervention follow-up.
System Usability Scale
Time frame: Month 6, Month 10, Month 12, Month 18
10-item technology agnostic scale assessing technology product usability. The total SUS score ranges from 0 to 100, with higher scores indicating higher usability. SUS scores above 80 indicated good usability. The SUS has high internal consistency (α=.91) and high convergent validity with a separate rating of usability and user satisfaction (r=.8). The present study will assess change system usability at the end of software development (month 6), during the intervention trial (month 10), at post-treatment (month 12), and at 6-months post-intervention follow-up (month 18).
3 secondary outcomes
Barkley Deficits in Executive Functioning Scale (BDEFS-CA)
Time frame: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
Behavioral Inhibition System/ Behavioral Activation System, BIS/BAS Scales
Time frame: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
Revised Child Anxiety and Depression Scales (RCADS)
Time frame: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Homework Organization and Planning Skills (HOPS) Intervention and Digital Health Application (Online Platform) for Encouraging Skills Practice in people with ADHD and Attention Deficit Hyperactivity Disorder, run by Children's National Research Institute 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 5 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: status not confirmed, as of the sponsor's last update on 21 Feb 2023. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melissa R Dvorsky, Ph.D. (202-476-5000, ATOM@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vanderbilt ADHD Diagnostic Rating Scales (VADRS) Parent Version (time frame: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention). The study lists 5 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 21 Feb 2023.