UnknownPhase 1

Technology-Enhanced Executive Functioning Intervention for ADHD

United States60 participantsStarted 2021-02-03

Plain-language 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 (phase 2), and a pilot randomized trial (phase 3) of the online tool used in conjunction with an organizational skills intervention.

Who can participate

Age range

11 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Vanderbilt ADHD Diagnostic Rating Scales (VADRS) Parent Version

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention

System Usability Scale

Timeframe: Month 6, Month 10, Month 12, Month 18

Trial details

NCT IDNCT04729439

SponsorChildren's National Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-14

Contact for this trial

Melissa R Dvorsky, Ph.D.

202-476-5000 ATOM@childrensnational.org

View on ClinicalTrials.gov More ADHD trials

Plain-language summary

Who can participate

Age range

11 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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.

What they're measuring

Vanderbilt ADHD Diagnostic Rating Scales (VADRS) Parent Version

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Change from Baseline (month 0) to Immediate Post-Intervention (up to 12 weeks later) and 6-months Post-Intervention

System Usability Scale

Timeframe: Month 6, Month 10, Month 12, Month 18