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Technology-Enhanced Executive Functioning Intervention for ADHD

Phase 1
Recruiting
Research Sponsored by Children's National Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Youth ages of 11 to 14 that are attending a participating school
≥6 symptoms (item score ≥2) of Inattention or Hyperactivity-Impulsivity on the pooled parent and teacher Vanderbilt ADHD Rating Scale
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6, month 10, month 12, month 18
Awards & highlights

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.

Who is the study for?
This trial is for adolescents aged 11-14 with ADHD, attending a participating school and showing significant symptoms and impairment. They must have parental consent, be referred by a school mental health provider, and not plan to change their psychotropic medication during the study.Check my eligibility
What is being tested?
The study tests an online platform designed to help teens with ADHD improve organizational skills. It involves focus groups, usability testing, and a pilot randomized trial where some participants use this digital tool alongside traditional behavioral interventions.See study design
What are the potential side effects?
Since this intervention is non-medical focusing on skill development through technology, typical medical side effects are not expected. However, users may experience frustration or fatigue from regular use of the digital application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 11 and 14 years old and attend a participating school.
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I have 6 or more symptoms of ADHD according to the Vanderbilt scale.
Select...
I am between 11 and 14 years old and attend a participating school.
Select...
I have 6 or more symptoms of ADHD according to the Vanderbilt scale.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6, month 10, month 12, month 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6, month 10, month 12, month 18 for reporting.

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 more
Secondary 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)

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 Location

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor
209 Previous Clinical Trials
207,685 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
250 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Media Library

Homework Organization and Planning Skills (HOPS) Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04729439 — Phase 1
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Organizational/behavioral intervention only, Organizational/behavioral intervention + digital health tool
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Homework Organization and Planning Skills (HOPS) Intervention Highlights & Side Effects. Trial Name: NCT04729439 — Phase 1
Homework Organization and Planning Skills (HOPS) Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04729439 — Phase 1

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

Why did patients apply to this trial?

I have been taking medication to help with focus.
PatientReceived 2+ prior treatments
~9 spots leftby Nov 2024