BUILT Family Lifestyle Program for Children With ADHD (BUILT)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Be Unstoppable in Life Together (BUILT)
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Lifestyle Intervention, Routines, Behavior change, Community-engaged research
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Chicago Park DistrictRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BUILT Study
Arm Description
One group receives the intervention.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05464056
First Posted
May 26, 2022
Last Updated
July 14, 2022
Sponsor
University of Illinois at Chicago
Collaborators
UIC Center for Health Equity Research (CHER), UIC Chicago Partnership for Health Promotion (CPHP), National Institute on Minority Health and Health Disparities (NIMHD)
1. Study Identification
Unique Protocol Identification Number
NCT05464056
Brief Title
BUILT Family Lifestyle Program for Children With ADHD
Acronym
BUILT
Official Title
BUILT Family Lifestyle Program for Children With ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2022 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
UIC Center for Health Equity Research (CHER), UIC Chicago Partnership for Health Promotion (CPHP), National Institute on Minority Health and Health Disparities (NIMHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. Over 8-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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Lifestyle Intervention, Routines, Behavior change, Community-engaged research
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
316 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BUILT Study
Arm Type
Experimental
Arm Description
One group receives the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Be Unstoppable in Life Together (BUILT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Moderate-Vigorous Physical Activity at Posttest
Description
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.
Time Frame
Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Title
Change from Baseline Sleep Quantity at Posttest
Description
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.
Time Frame
Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Title
Change from Baseline Diet Quality at Posttest
Description
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.
Time Frame
Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Title
Change from Baseline Recreational Screen Time Quantity at Posttest
Description
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.
Time Frame
Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Secondary Outcome Measure Information:
Title
Change from Baseline Combined ADHD Symptoms at Posttest
Description
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.
Time Frame
Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Title
Change from Baseline Functional Impairment at Posttest
Description
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.
Time Frame
Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Title
Change from Baseline Executive Function at Posttest
Description
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.
Time Frame
Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Title
Change from Baseline Parental Stress at Posttest
Description
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.
Time Frame
Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Title
Change from Baseline Home Structure at Posttest
Description
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.
Time Frame
Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Title
Change from Baseline Family Cohesion at Posttest
Description
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.
Time Frame
Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Title
Change from Baseline Parent-Child Communication at Posttest
Description
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.
Time Frame
Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Title
Change from Baseline Physical Literacy at Posttest
Description
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.
Time Frame
Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Title
Change from Baseline Child Resilience at Posttest
Description
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.
Time Frame
Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Title
Change from Baseline Social Capital at Posttest
Description
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.
Time Frame
Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo E Bustamante, PhD
Phone
312-413-7270
Email
ebusta2@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo E Bustamante, PhD
Organizational Affiliation
University of Illinois Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chicago Park District
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Escareno
Phone
312-742-4200
Email
Superintendent.Escareno@chicagoparkdistrict.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BUILT Family Lifestyle Program for Children With ADHD
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