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NCT04219280RECRUITINGIRB Ready

Evaluating Treatment of ADHD in Children with Down Syndrome

(TEAM-DS)

Sponsored by Children's Hospital Medical Center, Cincinnati

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 100 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

Children with Down syndrome (DS) have a 3-5 time greater prevalence of Attention Deficit Hyperactivity Disorder (ADHD) than typically developing (TD) children. Despite this higher risk of ADHD, rates of stimulant medication treatment are disproportionately low in children with DS+ADHD, even though stimulants are the most efficacious ADHD treatment and are recommended by consensus guidelines for use in children with intellectual disability and ADHD.

Who Can Participate

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study.
Male or female, between the ages of 6.00-17.99 years at the time of consent.
Able to take oral (liquid) medication.
English is primary language.
Meets criteria for ADHD (hyperactivity, inattention, or combined) on the KSADS
Meets criteria for ADHD (hyperactivity, inattention, or combined) on the Vanderbilt (historically or currently, as indicated by a teacher/professional)

Exclusion Criteria

Current use of ADHD stimulant or non-stimulant medication and unwilling to discontinue for \>/= 3 days prior to starting the study.
Children with psychoses or bipolar disorder based on diagnostic interview with the parent.
Organic Brain Injury: Children must not have a history of head trauma with loss of consciousness, epilepsy, or any other organic disorder that could possibly affect brain function.
Specific heart conditions including the following:

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

100 participants

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Age Range

6 Years - 17 Years

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Gender

ALL

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Sponsor

Children's Hospital Medical Center, Cincinnati

Study Locations

Choose your preferred location or select flexible during enrollment

COMPLETED

Sacramento

California

Location available
View Sacramento location page
RECRUITING

Boston

Massachusetts

Location available
View Boston location page
RECRUITING

Cincinnati

Ohio

Location available
View Cincinnati location page
RECRUITING

Pittsburgh

Pennsylvania

Location available
View Pittsburgh location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for ADHD Treatment in Sacramento?

Join others in California exploring innovative treatment options through clinical research

ADHD Treatment Options in Sacramento, California

If you're searching for ADHD treatment in Sacramento, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Sacramento, Boston, Cincinnati and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with ADHD. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 100 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for ADHD?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for ADHD

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This ADHD Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04219280. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.