Diagnostic Algorithm for ADHD

N/A

Recruiting

Led By Jeffrey Newcorn, MD Professor

Research Sponsored by MindTension

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the beginning of clinical assessment until the end of testing (approximately 1-2 days).

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to show that the MT1 algorithm, used with the MindTension biometric sensor device, can help healthcare providers diagnose ADHD in children and teenagers between the ages of 6 and 17.

Who is the study for?

This trial is for children aged 6 to 17 who may have ADHD. They must be willing to follow the study rules and can't have taken stimulants recently, or they must stop them for three days before testing. Kids with ADHD symptoms confirmed by specific assessments are included, while those without any diagnosable disorder on these tests are excluded.

What is being tested?

The study is testing a new tool called the MT1 algorithm with a device named MindTension that measures how kids react to sounds. It's being compared to an established test (T.O.V.A.) to see if it helps doctors diagnose ADHD more accurately in young people.

What are the potential side effects?

Since this trial involves diagnostic procedures rather than medication, there aren't typical side effects like you'd expect from drugs. However, participants might feel bored or uncomfortable sitting through the tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the beginning of clinical assessment until the end of testing (approximately 1-2 days).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the beginning of clinical assessment until the end of testing (approximately 1-2 days).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the beginning of clinical assessment until the end of testing (approximately 1-2 days). for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall Agreement Rate (OAR) - probability that the test will be normal and the condition is normal or positive and the condition is positive, out of all subjects.

Secondary study objectives

Negative Predicted Value (NPV) - conditional probability that the condition will be normal if the test is normal.

Positive Predicted Value (PPV) - conditional probability that the condition will be positive if the test is positive.

Sensitivity - conditional probability that the test will be positive if the condition is positive.

+1 more

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

Group I: Non-ADHD groupExperimental Treatment2 Interventions

Subjects will be evaluated using clinically established reference standard interviews and psychometric tools with demonstrated validity, including the K-SADS and ADHD-RS-5, in accordance with DSM-5 criteria. IQ will be estimated using two subtests of the WASI.

Group II: ADHD groupExperimental Treatment2 Interventions

Subjects will be evaluated for ADHD using clinically established reference standard interviews and psychometric tools with demonstrated validity, including the K-SADS and ADHD-RS-5, in accordance with DSM-5 criteria. IQ will be estimated using two subtests of the WASI.

Do I qualify?Apply below to find out