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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
Must not have
Adolescent is in all-day special education classes or if core classes not in regular education classrooms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6, month 10, month 12, month 18
Awards & highlights

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am enrolled in all-day special education or core classes outside regular classrooms.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for ADHD include stimulant medications, non-stimulant medications, and behavioral interventions. Stimulant medications like methylphenidate and amphetamines increase dopamine and norepinephrine levels in the brain, improving attention and reducing impulsivity and hyperactivity. Non-stimulant medications such as atomoxetine enhance attention and impulse control by selectively inhibiting norepinephrine reuptake. Behavioral interventions, including organizational skills training, focus on improving executive functioning by teaching strategies to manage time, tasks, and behaviors effectively. These treatments are essential for ADHD patients as they address core symptoms and improve daily functioning, thereby enhancing overall quality of life.
Bibliotherapy as an adjunct to stimulant medication in the treatment of attention-deficit hyperactivity disorder.An evidence-based medicine approach to combined treatment for ADHD in children and adolescents.

Find a Location

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor
214 Previous Clinical Trials
253,476 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
~5 spots leftby Nov 2024