Attention Deficit Hyperactivity DisorderBUILTNCT05464056
BUILT Family Lifestyle Program for Children With ADHD
A study testing Be Unstoppable in Life Together (BUILT) in people with Attention Deficit Hyperactivity Disorder, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The investigators have developed BUILT in hopes of empowering families to adopt and sustain healthy food, sleep, and exercise routines that optimize child focus, attention, and behavior. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Be Unstoppable in Life Together (BUILT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2022to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Boys and girls ages 6 to 12 years old
- Parent orientation session summarizing activities
- Child free of conditions that preclude aerobic activity
- Child enrolled in Chicago Park District programming
Who cannot join
- Boys and girls < 6 years old or > 12 years old
- Parent does not participate in orientation session summarizing activities
- Child has conditions that preclude aerobic activity
- Child not enrolled in Chicago Park District programming
Trial locations and contacts
1 site in 1 country.
About this study
The investigators have developed BUILT in hopes of empowering families to adopt and sustain healthy food, sleep, and exercise routines that optimize child focus, attention, and behavior. Over 6-weeks, the BUILT program will explore what science says about the effects of sleep, nutrition, and exercise on brain development and behavior; investigate the food, sleep, and exercise routines of the world's best athletes and intellectuals; and experiment with home routines to find those that best fits with participating families.
It is hypothesized that families participating in BUILT (N=150) will show significant improvements in child health behaviors (sleep, nutrition, physical activity, recreational screen time), child mental health (ADHD symptoms [primary outcome], child functional impairment), child physical literacy, and family dynamics (cohesion, structure, communication) from baseline to posttest.
Read the detailed description
Families enrolled in Chicago Park District programs will be offered the opportunity to participate in the BUILT family lifestyle program. Using a single group design, measures will be taken within two weeks of program start and two weeks after completion. Additional feasibility measures will be taken during the program itself to inform refinements across iterations. The BUILT program will occur largely on-line and consist of weekly home challenges related to food, sleep, and exercise that add up to form a comprehensive home routine--the routine will optimize neurocognitive development and home structure. The program will be co-facilitated by UIC students and Chicago Park District staff. For more information visit the program website: https://built.ahs.uic.edu.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Be Unstoppable in Life Together (BUILT)
- Keywords
- ADHD, Lifestyle Intervention, Routines, Behavior change, Community-engaged research
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Be Unstoppable in Life Together (BUILT)Behavioural
Participants will complete weekly sleep, food, and exercise home challenges focused on creating sustainable healthy eating, sleep, and exercise routines. Parents will participate in weekly support calls by UIC and Chicago Park District staff to provide support and accountability. Children will have the opportunity to win small prizes based on completing weekly challenges. The intervention will be co-facilitated by UIC students and Chicago Park District staff and will largely take place on-line. For additional details visit: https://built.ahs.uic.edu.
| Study group | Role | What they receive |
|---|---|---|
| BUILT Study | Experimental | One group receives the intervention. Receives: Behavioral: Be Unstoppable in Life Together (BUILT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Moderate-Vigorous Physical Activity at Posttest
Physical activity will be monitored for children at each time point with accelerometers worn at the wrist. Accelerometers provide a valid assessment of physical activity in free-living conditions. Data will be analyzed if ≥7 hours are available for ≥4 days. The outcome is minutes of moderate-vigorous physical activity per day and more minutes of moderate-vigorous physical activity are considered a better outcome.
Measured: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Sleep Quantity at Posttest
Sleep quantity will be monitored for children at each time point with accelerometers worn at the wrist. Accelerometers provide a valid assessment of sleep in free-living conditions. Sleep logs will differentiate sleep and wake times. More hours of sleep are considered a better outcome.
Measured: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Diet Quality at Posttest
Diet Quality will be assessed for each child at each time point using a Block Food Frequency Questionnaire (NutritionQuest). Higher scores on Diet Quality are considered a better outcome.
Measured: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Recreational Screen Time Quantity at Posttest
Recreational Screen time will be assessed by parent report of minutes of daily screen time on weekdays and weekends for school and non-school purposes, rounded to the nearest 15-minute increment. Fewer minutes of daily recreational screen time are considered a better outcome.
Measured: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Secondary outcomes (10)
Change from Baseline Combined ADHD Symptoms at Posttest
The Disruptive Behavior Disorder (DBD) Rating Scale lists the DSM-IV criteria for ADHD, ODD, and CD on a 4-point Likert scale from "not at all" to "very much." Each item is assigned a value (0 to 3) and these are summed to generate a continuous score on combined ADHD symptoms. Higher symptom scores are considered a worse outcome.
Measured: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Functional Impairment at Posttest
The Impairment Rating Scale (IRS) assesses the severity of a child's impairment and need for treatment and services. Raters place an X on a line that signifies the child's placement on a continuum of impairment across seven domains. Under each domain rating is a section for the rater to describe his or her view of the child in a narrative. For scoring, the line is divided into seven equally spaced segments, and the segment where the X was placed constitutes the score between 0 (no problem/definitely does not need treatment or special services) and 6 (extreme problem/definitely needs treatment or special services). A 3 or above is scored as an impaired domain and these are summed as a continuous outcome. Higher numbers of domains endorsed as impaired are considered a worse outcome.
Measured: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Executive Function at Posttest
The Behavioral Rating Inventory of Executive Function (BRIEF) assesses everyday manifestations of executive function. The tool consists of 86-items that use a scale from 0 "Never" to 2 "Often." The BRIEF generates a Global Executive Composite (GEC) score, which is standardized as a t-distribution where lower scores are considered a better outcome.
Measured: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Parental Stress at Posttest
Parental stress will be measured by the 10-item Perceived Stress Scale (PSS). Each item on the PSS uses a Likert scale ranging from 0 "Never" to 4 "Very Often." Higher scores on the PSS are considered a worse outcome.
Measured: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Home Structure at Posttest
The Family Routines Inventory (FRI) is a 56-item questionnaire that divides routines into two pieces: the frequency of the routines and the importance of the routine. The frequency of the routine is recorded on a Likert scale from 0 "Almost Never" to 3 "Always Everyday." The importance of the routine is recorded on a Likert scale from 0 "Not at All Important" to 2 "Very Important." Overall higher frequency and importance scores are considered a better outcome.
Measured: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Family Cohesion at Posttest
The Parenting and Family Adjustment Scale (PAFAS) is a brief measure of parental adjustment and parent-child relationship with good internal consistency and satisfactory construct and predictive validity. The PAFAS is a 30-item questionnaire that uses a 4-point scale from 0 (not at all) to 3 (very much). Subscales are summed into a family adjustment score where higher scores are considered a better outcome.
Measured: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Parent-Child Communication at Posttest
Parent-Child Communication will be measured with the Family Problem Solving Communication (FPSC) instrument, a 10-item measure of problem solving communication in families. A Likert scale is utilized for each statement and ranges from 0 "False" to 3 "True." A higher score on affirming communication and a lower score on incendiary communication are considered to be better outcomes.
Measured: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Physical Literacy at Posttest
The Physical Literacy Assessment for Youth (PLAYfun) provides an assessment of key movement skills performed by children. The tool itself is made up of 18 tasks that cover the child's physical abilities. Each ability is graded on a four-point rubric with the following categories: Initial, Emerging, Competent and Proficient. Higher scores are considered to be a better outcome.
Measured: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Child Resilience at Posttest
The Child and Youth Resilience Measure (CYRM-R) is a self-report measure of social-ecological resilience. This 17-item questionnaire uses a 5-point Likert scale that ranges from 0 "Not at All" to 4 "A Lot." Scores are summed and higher scores are considered a better outcome.
Measured: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Social Capital at Posttest
Social capital will be assessed by the 10-item Community Collective Efficacy (CCE) scale. The CCE uses a 5-point Likert scale ranging from 1 "Strongly Agree" to 5 "Strongly Disagree." Scores are summed and lower scores are considered a better outcome.
Measured: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start15 Jul 2022
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- UIC Center for Health Equity Research (CHER), UIC Chicago Partnership for Health Promotion (CPHP), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Eduardo E. Bustamante, University of Illinois Chicago
- Investigators
- Eduardo E Bustamante, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464056
- Sponsor's protocol ID
- 2017-0024
- Acronym
- BUILT
- Status last verified
- Mar 2025
- First submitted
- 26 May 2022
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BUILT Family Lifestyle Program for Children With ADHD
- ClinicalTrials.gov ID
- NCT05464056
- Acronym / sponsor ID
- BUILT / 2017-0024
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Lifestyle Intervention, Routines, Behavior change, Community-engaged research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- UIC Center for Health Equity Research (CHER), UIC Chicago Partnership for Health Promotion (CPHP), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators have developed BUILT in hopes of empowering families to adopt and sustain healthy food, sleep, and exercise routines that optimize child focus, attention, and behavior. Over 6-weeks, the BUILT program will explore what science says about the effects of sleep, nutrition, and exercise on brain development and behavior; investigate the food, sleep, and exercise routines of the world's best athletes and intellectuals; and experiment with home routines to find those that best fits with participating families.
It is hypothesized that families participating in BUILT (N=150) will show significant improvements in child health behaviors (sleep, nutrition, physical activity, recreational screen time), child mental health (ADHD symptoms [primary outcome], child functional impairment), child physical literacy, and family dynamics (cohesion, structure, communication) from baseline to posttest.
Detailed description
Families enrolled in Chicago Park District programs will be offered the opportunity to participate in the BUILT family lifestyle program. Using a single group design, measures will be taken within two weeks of program start and two weeks after completion. Additional feasibility measures will be taken during the program itself to inform refinements across iterations. The BUILT program will occur largely on-line and consist of weekly home challenges related to food, sleep, and exercise that add up to form a comprehensive home routine--the routine will optimize neurocognitive development and home structure. The program will be co-facilitated by UIC students and Chicago Park District staff. For more information visit the program website: https://built.ahs.uic.edu.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BUILT Study | Experimental | Behavioral: Be Unstoppable in Life Together (BUILT)One group receives the intervention. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Boys and girls ages 6 to 12 years old
- Parent orientation session summarizing activities
- Child free of conditions that preclude aerobic activity
- Child enrolled in Chicago Park District programming
Key exclusion criteria (4 listed)
- Boys and girls < 6 years old or > 12 years old
- Parent does not participate in orientation session summarizing activities
- Child has conditions that preclude aerobic activity
- Child not enrolled in Chicago Park District programming
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Be Unstoppable in Life Together (BUILT)Participants will complete weekly sleep, food, and exercise home challenges focused on creating sustainable healthy eating, sleep, and exercise routines. Parents will participate in weekly support calls by UIC and Chicago Park District staff to provide support and accountability. Children will have the opportunity to win small prizes based on completing weekly challenges. The intervention will be co-facilitated by UIC students and Chicago Park District staff and will largely take place on-line. For additional details visit: https://built.ahs.uic.edu. | Behavioural | BUILT Study |
Primary outcome
Change from Baseline Moderate-Vigorous Physical Activity at Posttest
Time frame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Physical activity will be monitored for children at each time point with accelerometers worn at the wrist. Accelerometers provide a valid assessment of physical activity in free-living conditions. Data will be analyzed if ≥7 hours are available for ≥4 days. The outcome is minutes of moderate-vigorous physical activity per day and more minutes of moderate-vigorous physical activity are considered a better outcome.
Change from Baseline Sleep Quantity at Posttest
Time frame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Sleep quantity will be monitored for children at each time point with accelerometers worn at the wrist. Accelerometers provide a valid assessment of sleep in free-living conditions. Sleep logs will differentiate sleep and wake times. More hours of sleep are considered a better outcome.
Change from Baseline Diet Quality at Posttest
Time frame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Diet Quality will be assessed for each child at each time point using a Block Food Frequency Questionnaire (NutritionQuest). Higher scores on Diet Quality are considered a better outcome.
Change from Baseline Recreational Screen Time Quantity at Posttest
Time frame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Recreational Screen time will be assessed by parent report of minutes of daily screen time on weekdays and weekends for school and non-school purposes, rounded to the nearest 15-minute increment. Fewer minutes of daily recreational screen time are considered a better outcome.
10 secondary outcomes
Change from Baseline Combined ADHD Symptoms at Posttest
Time frame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Functional Impairment at Posttest
Time frame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Executive Function at Posttest
Time frame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Parental Stress at Posttest
Time frame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Home Structure at Posttest
Time frame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Family Cohesion at Posttest
Time frame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Parent-Child Communication at Posttest
Time frame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Physical Literacy at Posttest
Time frame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Child Resilience at Posttest
Time frame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Change from Baseline Social Capital at Posttest
Time frame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo E Bustamante, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Be Unstoppable in Life Together (BUILT) in people with Attention Deficit Hyperactivity Disorder, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Moderate-Vigorous Physical Activity at Posttest (time frame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.