What side effects are associated with this type of intervention?

The most common treatments for ADHD include stimulant medications such as methylphenidate and amphetamines, as well as behavioral interventions focusing on sleep, nutrition, and exercise. Stimulant medications are generally well-tolerated but can cause side effects such as decreased appetite, nausea, vomiting, insomnia, and, in some cases, cardiovascular issues. Behavioral interventions, like those studied in the BUILT Program, aim to improve sleep, nutrition, and physical activity, and typically do not have adverse side effects. Instead, they may lead to improvements in overall health behaviors, mental health, and family dynamics.

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 managing core symptoms. Nonstimulant medications such as atomoxetine and extended-release guanfacine have also been approved. These medications help control symptoms and improve self-esteem in children with ADHD. While the BUILT Program emphasizes behavioral interventions focusing on sleep, nutrition, and exercise, these elements are often recommended alongside pharmacotherapy to optimize overall treatment outcomes. Comprehensive treatment plans typically include both medication and behavioral strategies to address the multifaceted needs of children with ADHD.

What other types of research exist?

Promising alternatives to the BUILT Program for ADHD patients include: 1) Mindfulness-Based Cognitive Therapy (MBCT), which combines mindfulness training with cognitive therapy and has shown positive results in some studies. 2) Yoga exercises, which have been found to complement behavioral interventions by improving attention and inhibition. 3) Oligoantigenic (few-foods) diets, which may benefit specific subgroups of ADHD patients. 4) Biofeedback, which is a mind-body therapy used to treat various conditions and may help in managing ADHD symptoms. These alternatives focus on behavioral and lifestyle modifications similar to the BUILT Program.

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Behavioral Intervention

BUILT Family Lifestyle Program for ADHD (BUILT Trial)

N/A

Recruiting

Led By Eduardo E Bustamante, PhD

Research Sponsored by University of Illinois at Chicago

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 baseline (within 2-weeks of intervention start date), posttest (within 2-weeks of intervention end date)

Awards & highlights

Summary

This trial tests the BUILT program, an online course for families in Chicago Park District programs. It aims to improve children's health and behavior through better food, sleep, and exercise routines. Families will participate in challenges to build these healthy habits.

Who is the study for?

The BUILT program is for boys and girls aged 6 to 12 with ADHD, who are enrolled in Chicago Park District programs. They must be able to do aerobic activities and have a parent willing to attend an orientation session.

What is being tested?

BUILT aims to improve children's focus, attention, and behavior through better food, sleep, and exercise routines over an 8-week course. It will measure changes in health behaviors, mental health (especially ADHD symptoms), physical literacy, and family dynamics.

What are the potential side effects?

Since BUILT focuses on lifestyle improvements rather than medication or medical procedures, no direct side effects are expected from the program itself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (within 2-weeks of intervention start date), posttest (within 2-weeks of intervention end date)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (within 2-weeks of intervention start date), posttest (within 2-weeks of intervention end date)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (within 2-weeks of intervention start date), posttest (within 2-weeks of intervention end date) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from Baseline Diet Quality at Posttest

Change from Baseline Moderate-Vigorous Physical Activity at Posttest

Change from Baseline Recreational Screen Time Quantity at Posttest

+1 more

Secondary study objectives

Change from Baseline Child Resilience at Posttest

Change from Baseline Combined ADHD Symptoms at Posttest

Change from Baseline Executive Function at Posttest

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: BUILT StudyExperimental Treatment1 Intervention

One group receives the intervention.

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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 behavioral interventions, stimulant medications, and non-stimulant medications. Behavioral interventions, like those in the BUILT Program, focus on improving sleep, nutrition, and exercise, which can enhance brain function and reduce ADHD symptoms by promoting overall health and well-being. Stimulant medications, such as methylphenidate and amphetamines, work by increasing the levels of dopamine and norepinephrine in the brain, which helps improve attention and reduce impulsivity and hyperactivity. Non-stimulant medications, like atomoxetine, increase norepinephrine levels without the stimulant effects, providing an alternative for patients who may not respond well to stimulants. These treatments are crucial for ADHD patients as they address the underlying neurochemical imbalances and behavioral issues, leading to better management of symptoms and improved daily functioning.

Sleep in Individuals with ADHD: Prevalence, Impacts, Causes, and Treatments.Integrated pharmacologic treatment of attention-deficit hyperactivity disorder (ADHD).

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor

632 Previous Clinical Trials

1,567,399 Total Patients Enrolled

2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)

530 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

UIC Center for Health Equity Research (CHER)UNKNOWN

UIC Chicago Partnership for Health Promotion (CPHP)UNKNOWN

Media Library

Be Unstoppable in Life Together (BUILT) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05464056 — N/A

Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: BUILT Study

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Be Unstoppable in Life Together (BUILT) Highlights & Side Effects. Trial Name: NCT05464056 — N/A

Be Unstoppable in Life Together (BUILT) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05464056 — N/A

~100 spots leftby Sep 2025

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