What side effects are associated with this type of intervention?

Common treatments for ADHD include stimulant medications such as methylphenidate and amphetamines, which can cause side effects like insomnia, decreased appetite, weight loss, increased heart rate, and potential for substance misuse. Non-stimulant medications like atomoxetine and guanfacine may lead to side effects such as fatigue, gastrointestinal issues, and changes in blood pressure. Behavioral therapies and organizational skills interventions, including those delivered through online platforms, generally have fewer side effects but may cause initial frustration or anxiety as new routines and skills are being learned.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of ADHD, including stimulants like methylphenidate and amphetamines, which are effective in reducing core symptoms of ADHD. Non-stimulant medications such as atomoxetine and extended-release guanfacine have also been approved and are used to manage symptoms. These medications can help improve behavioral and organizational skills, which are critical areas of focus in interventions like the Organizational Skills Intervention being studied. Additionally, combining these medications with behavioral therapies has shown to enhance overall treatment outcomes.

What other types of research exist?

Promising novel alternatives to Organizational Skills Intervention for ADHD patients include: 1) Online Mindfulness-Based Interventions (iMBI), which have shown potential in reducing inattention and hyperactivity-impulsivity and improving executive functioning. 2) Family Skills Training for ADHD-Related Symptoms (Family STARS), which combines behavioral parent training and child-focused behavioral activation therapy. 3) Web-Based Interventions for Teachers, which provide evidence-based strategies to reduce ADHD symptoms and impairment in the classroom setting. These alternatives leverage technology and comprehensive approaches to address ADHD symptoms effectively.

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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

No Placebo-Only Group

Summary

This trial is developing an online tool to help teenagers with ADHD improve their organizational skills. The tool uses fun activities and rewards to keep teens engaged, tracks their progress, and involves their families. It aims to make learning more effective and enjoyable for teens who struggle with traditional treatments.

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.

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.

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.

Select...

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:

Select...

I am enrolled in all-day special education or core classes outside regular classrooms.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Impairment Rating Scale (IRS) Parent Version

Impairment Rating Scale (IRS) Teacher Version

System Usability Scale

+2 more

Secondary study objectives

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

0 / 3Eligibility criteria met

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.