Whether you’re exploring new treatment options, interested in research, or just looking for more information, we’re glad you’re here. It’s natural to have questions about what a clinical trial is, what it involves, and whether it is the right fit for your family. Our team is here to help you understand the clinical trial process so you can make an informed decision that is right for you.

What Is a Clinical Trial?

A clinical trial is a type of research study that tests whether new treatments—such as medications, behavioral therapies, or digital devices—are safe and effective.

Clinical trials are necessary to advance the field of psychiatry. These studies help us discover new and more effective treatments, understand how current therapies work for different people, and improve the overall quality of care for those living with mental health conditions.

Why Do We Have Clinical Trials?

We conduct clinical trials to accomplish the following:

• develop new treatment options for mental health conditions that are difficult to manage with current approaches
• improve existing treatments by learning how they work in different ages, diagnoses, or symptom presentations
• ensure safety and effectiveness of new medications and therapies before they are made widely available
• advance early detection and diagnosis by studying new tools and technologies
• personalize care to individual needs

Every clinical trial contributes to the growing body of knowledge in mental health, helping us deliver more thoughtful, effective, and individualized care.

What Is an Example of a Clinical Trial?

In psychiatry, clinical trials may explore many kinds of questions to help improve mental health care. These are some of the different types of clinical studies that may be conducted:

• testing new medications, devices, or other treatments (for instance, investigating a new antidepressant for adolescents with treatment-resistant depression)
• developing new screening or diagnostic methods (for instance, testing a new digital tool to spot early signs of ADHD in children)
• exploring new uses for existing treatments (for instance, studying whether a medication already approved for schizophrenia may help manage irritability in patients with autism)
• understanding how the brain or treatment works in healthy volunteers (for instance, studying the effects of sleep on attention in healthy adolescents)
• focusing on one mental health diagnosis or condition, and aiming to test new treatments or approaches for that specific group—such asa study testing a new therapy for youth with obsessive–compulsive disorder (OCD)

What Happens in a Clinical Trial?

If you are considering enrolling your child in one of our studies, our team is here to guide and support you at every step.

Screening and Informed Consent

During screening and informed consent, you meet with a member of our research team who walks you through study details. You learn about what participation looks like at each of the clinical trial visits and any potential risks or benefits. You also have time to ask questions. We may ask some screening questions to see if your child is eligible to take part in the study. Parents or legal guardians are required to provide written permission (called consent), and in most cases, children are also asked to give verbal or written agreement (assent), depending on their age.

Eligibility Evaluation

Some studies have very specific criteria, such as age range, diagnosis, or treatment history, to make sure the research is a good fit for your child. Your child may complete some initial assessments, such as physical exams, short surveys, or questionnaires, to determine if they are eligible.

Participation and Visits

If your child is eligible and you consent to enroll them in the study, your child will attend study visits that may include medical checkups, lab tests, interviews, or answering surveys. Some studies may involve taking a study medication, testing out a new medical device, or participating in a behavioral intervention. Caregivers are often asked to share their observations about their child’s health and behavior, and to complete questionnaires or surveys. The number of visits, the length of visits, and how long the study lasts varies depending on the trial.

Monitoring and Support

Your child’s wellbeing is our top priority. Our research team checks in regularly to monitor your child’s health and is available during and between visits to answer any questions. You will be given contact information to our lead doctor on the study (called the principal investigator, or PI) and the study team’s research coordinator, as well as the ethics board (Institutional Review Board) if you need additional support. You can choose to stop participation at any time, and your decision—whether to take part or not—never affects the care your child receives at NYU Langone.

What Are the Different Phases of Clinical Trials?

Clinical trials usually happen in steps, called phases, to make sure any new treatments that become available are safe and effective. Each phase has a specific purpose:

• Phase 1 studies test a new treatment. This is usually done in a small group that is often made up of healthy volunteers or those with the condition. The goal of this is to learn about the treatment’s safety, determine appropriate dosage, and identify any potential side effects.
• Phase 2 expands testing to a larger group and involves more participants with a specific condition. The goal of this phase is to focus on how well the treatment works and to continue monitoring for side effects.
• Phase 3, which expands to an even larger group of participants, compares the new treatment to standard treatments or placebo (no treatment). This phase helps confirm how well the treatment works, how it compares to what is already available, and how safe it is across different people. This usually provides key data to move the treatment toward approval.
• Phase 4 studies happen after the treatment has been approved by the Food and Drug Administration (FDA) and has become available to the public. Researchers collect long-term data on safety, effectiveness, and how the treatment performs in everyday, real-world use.

Why Participate?

Families decide to participate in clinical trials for many reasons, including these:

• access to promising new treatments before they become widely available
• opportunities to explore new approaches when existing treatments haven’t been effective
• new insights into a child’s symptoms, diagnosis, or response to care
• close collaboration with research teams who may offer additional resources, guidance, and support throughout the process
• access to treatment, assessments, or testing at no cost
• the chance to contribute to research that may lead to better, more effective treatments for others

Where Can I Get More Information?

The resources below offer additional information about how clinical trials work, what to expect, and how to explore current research opportunities:

• ClinicalTrials.gov: a searchable, global database of clinical studies, with information on study goals, participation criteria, locations, and study collaborators
• FDA Step 3 Clinical Research : an overview of the clinical trial process that explains the route from development of new therapies to FDA approval
• NIH Clinical Trials and You: Parents and Children : a family-friendly site with explanations of what participation is like for children and what caregivers should know, links to videos explaining the importance of participating in research, and a link to additional resources