Digital Health Application (Online Platform) for Encouraging Skills Practice for Attention Deficit Hyperactivity Disorder (ADHD)
Children's National Research Institute, Washington, United States
Targeting 6 different conditionsDigital Health Application (Online Platform) for Encouraging Skills Practice +1 morePhase 1RecruitingResearch Sponsored by Children's National Research InstituteEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥3 on the Impairment Rating Scale by parent and teacher (cross-situational impairment)
≥6 symptoms (item score ≥2) of Inattention or Hyperactivity-Impulsivity on the pooled parent and teacher Vanderbilt ADHD Rating Scale
Must not have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upmonth 6, month 10, month 12, month 18
Awards & highlights
No Placebo-Only Group
Study Summary
This trial will create and refine an online platform to help clinicians treat adolescents with ADHD through behavioral and organizational skills interventions, with guidance from key stakeholders.
Eligible Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
Parents and teachers have rated you with a score of 3 or higher on a scale that measures how much your behavior affects your daily life at home and school.
Select...
You have at least 6 symptoms of inattention or hyperactivity-impulsivity, as reported by both your parents and teachers on the Vanderbilt ADHD Rating Scale.
Select...
Both your parents and teachers have noticed significant difficulties in your daily life activities, like schoolwork or behavior.
Select...
You have at least 6 symptoms of inattention or hyperactivity-impulsivity, as reported by both your parents and teachers on the Vanderbilt ADHD Rating Scale.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6, month 10, month 12, month 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6, month 10, month 12, month 18
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Impairment Rating Scale (IRS) Parent Version
Impairment Rating Scale (IRS) Teacher Version
System Usability Scale
+2 moreSecondary outcome measures
Barkley Deficits in Executive Functioning Scale (BDEFS-CA)
Behavioral Inhibition System/ Behavioral Activation System, BIS/BAS Scales
Revised Child Anxiety and Depression Scales (RCADS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Organizational/behavioral intervention + digital health toolExperimental Treatment2 Interventions
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
Group II: Organizational/behavioral intervention onlyActive Control1 Intervention
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
Find a site
Who is running the clinical trial?
Children's National Research InstituteLead Sponsor
198 Previous Clinical Trials
206,367 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
250 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age limit for participation in this trial under 55 years old?
"This clinical trial has specified that participants must be between 11 and 14 years old. 339 studies are recruiting for patients younger than 18, while 651 trials cater to those above the age of 65."
Answered by AI
Are there particular criteria for qualifying to partake in this trial?
"This trial is looking to enrol 60 individuals who demonstrate Attention Deficit Hyperactivity Disorder - Inattentive type and are 11-14 years of age."
Answered by AI
Is utilization of the Digital Health Application a secure way to build skills?
"Our team at Power assigned a score of 1 to the Digital Health Application (Online Platform) for Encouraging Skills Practice, due to it being in Phase 1 clinical trials with limited evidence supporting efficacy and safety."
Answered by AI
Is recruitment still open for participation in this research project?
"According to clinicaltrials.gov, this investigation is currently enrolling participants; it was initially published on February 3rd 2021 and the details were last revised on October 19th 2021."
Answered by AI
How many participants have enrolled in this research trial?
"Affirmative, according to information published on clinicaltrials.gov, the trial is actively enrolling patients at this present moment. It was first uploaded in February 2021 and updated last month. In total, 60 participants need to be recruited from a single medical centre."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
Maryland
Pennsylvania
Other
How old are they?
18 - 65
What site did they apply to?
Children's National Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0