ADHDLEAPNCT03690674
Lifestyle Enhancement for ADHD Program
A study testing Lifestyle Enhancement for ADHD Program in people with ADHD, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to investigate if physical activity (PA) can increase in children with Attention Deficit/Hyperactivity Disorder (ADHD) using a modified behavioral management training (BMT) program. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- Lifestyle Enhancement for ADHD Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2018to 21 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age 5-10 years
- ADHD diagnosis
- CGI-S rating >4 and <7
- Per caregiver report, engage in <60 min/day of MVPA for at least 5 days per week
- One adult caregiver willing to participate in the study and complete baseline/follow-up measures
- Caregiver able to complete forms in English
- Caregiver owns a smart phone or similar Garmin compatible mobile device (e.g. iPod Touch) or willing to borrow iPod from study coordinators during the study period
- Agree to install and share data from the Garmin smart phone app with investigators
Who cannot join
- younger than 5 years old or older than 10 years old
- do not meet criteria for ADHD diagnosis
- Meet diagnostic criteria for psychiatric co-morbidities including Autism Spectrum Disorder, Depressive Disorder, Mood Disorder, Psychotic Disorder, or Intellectual Disability that could interfere with intervention uptake
- Per caregiver report, engage in >60 min/day of MVPA for at least 5 days per week
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Research Institute
Seattle, Washington, 98145
About this study
The purpose of this study is to investigate if physical activity (PA) can increase in children with Attention Deficit/Hyperactivity Disorder (ADHD) using a modified behavioral management training (BMT) program.
Read the detailed description
The purpose of this study is to increase physical activity (PA) in children with ADHD using a novel, family-based intervention that promotes PA within the context of evidence-based behavioral management training (BMT) for parents, enhanced with mobile health (mHealth) behavior change strategies. Our first aim is to test the feasibility and acceptability, of an 8-week, family-based, multi-level intervention (BMT-Health) to promote PA in young children with ADHD. Our second aim is to derive an estimate of the effect size of the intervention on PA.
- Conditions
- ADHD
- Being tested
- Lifestyle Enhancement for ADHD Program
- Keywords
- ADHD, Physical Activity, Behavioral Management Training, Mobile Health
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Enhancement for ADHD ProgramBehavioural
Also called LEAP
The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Enhancement for ADHD Program | Experimental | There is no comparison/control arm. Receives: Behavioral: Lifestyle Enhancement for ADHD Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate to Vigorous Physical Activity (MVPA)
Measured by accelerometer worn by participating children
Measured: Baseline (measured prior to week 1 of Treatment Group) and week 9
Garmin Wear Time
The length of time (in days) each participant wore the Garmin device as a measure of feasibility
Measured: Weeks 1 - 9
Number of Facebook Posts
The amount of contribution to the Facebook page (comments, likes, etc) by each participant is a measure of feasibility
Measured: Weeks 1 - 9
Number of Caregivers With Attendance at the Focus Group
Attendance will be taken at the focus group as a measure of study acceptability
Measured: Week 9
Secondary outcomes (10)
Stop Signal Reaction Time (SSRT) Task Score
Measure of executive function completed by the child. Score is time in ms for participant to respond. Lower score is better.
Measured: Baseline to week 9
Digit Span (DS) Task - Total Score
Measure of executive function completed by the child. Digit Span Task. Minimum score: 0; Maximum score: 54. Higher score is better outcome.
Measured: Baseline to week 9
Finger Windows (FW) Task
Measure of executive function completed by the child
Measured: Change between baseline and week 9
Behavior Rating Inventory of Executive Function (BRIEF)
Measure of executive function completed by the parent. Parent rates whether the child displays each behavior never, sometimes, or often. Global Executive Composite Score: Minimum 35; Maximum 90. Higher score indicates better outcome.
Measured: Change between baseline and week 9
Impairment Rating Scale (IRS)
Measure of functional impairment completed by the parent. The rating scale measures from 0 to 7, where 0 equals no problem and 7 equals extreme problem. Outcome provided as mean of total raw score. Minimum: 0; Maximum: 100. Higher number indicates higher impairment.
Measured: Change between baseline and week 9
Alabama Parenting Questionnaire (APQ)
Measure of parenting completed by the parent. The responses are on a 1-5 scale, 1 equals never and 5 equals always. Outcome provided as total raw score. Minimum: 9; Maximum: 45.Higher number indicates better outcome.
Measured: Change between baseline and week 9
Health Behaviors Survey
Measure of physical activity, sleep, media use, medication use and complementary/alternative medicine use. Measure reported is the number of Caregivers responding 'yes' to item.
Measured: Baseline and week 9
Child's Sleep Habits Questionnaire (Pre-school and School-aged Children)
The Child's Sleep Habits Questionnaire (pre-school and school-aged children) is a measure of sleep problems completed by the parent. The parent rates each behavior based on their frequency: 'Usually' if something occurs 5 or more times in a week, 'Sometimes' if it occurs 2-4 times in a week, or 'rarely' if something occurs never or 1 times during a week. Parents can also indicate whether or not a sleep habit is a problem by choosing Yes, No, or Not applicable. Total score provided is the sum of all 33 items. Item units are on a scale of 1 -3 points. The Total score range is 33 - 99. The higher the number, the more sleep problems are indicated for the child.
Measured: Baseline and week 9
Conners-3 Questionnaire
Measure of ADHD symptoms reported by the parent. The scale ranges from 0 to 3 with 0 equaling not true at all and 3 equaling very much true. The Conners t-score range from 0 - 100. The higher the number, the worse the outcome.
Measured: Change between baseline and week 9
Teacher Vanderbilt
Pre and Post measures of ADHD symptoms reported by the teacher. The measure items' scale ranges from 0 to 3, with 0 equaling never and 3 equaling very often. The Inattention outcome measure reported is the average number of items (symptoms) in the Inattention Sub-scale of the Vanderbilt that teachers rated their students as 2 or higher on the 0-3 scale. There are 9 items in the Inattention sub-scale, and the range of Inattention Symptoms reported by the teacher is 0-9. The Hyperactive/Impulsive outcome measure reported is the average number of items (symptoms) in the Hyperactive/Impulsive Sub-scale of the Vanderbilt that teachers rated their students as 2 or higher on the 0-3 scale. There are 9 items in the Hyperactive/Impulsive sub-scale, and the range of Hyperactive/Impulsive Symptoms reported by the teacher is 0-9.The higher the number, the more symptoms teachers are reporting.
Measured: Baseline and week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start15 Nov 2018
- Primary completion9 Dec 2019
- Study completion21 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ADHDStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Pooja Tandon, Seattle Children's Hospital
- Investigators
- Pooja Tandon, MD, Principal investigator, Seattle Children's HospitalErin Gonzalez, MD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690674
- Sponsor's protocol ID
- STUDY00001046
- Other IDs
- R21AT010041-01
- Acronym
- LEAP
- Status last verified
- Mar 2022
- First submitted
- 18 Sep 2018
- Last updated
- 21 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Enhancement for ADHD Program
- ClinicalTrials.gov ID
- NCT03690674
- Acronym / sponsor ID
- LEAP / STUDY00001046
- Conditions
- ADHD
- Keywords
- ADHD, Physical Activity, Behavioral Management Training, Mobile Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Posted 21 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate if physical activity (PA) can increase in children with Attention Deficit/Hyperactivity Disorder (ADHD) using a modified behavioral management training (BMT) program.
Detailed description
The purpose of this study is to increase physical activity (PA) in children with ADHD using a novel, family-based intervention that promotes PA within the context of evidence-based behavioral management training (BMT) for parents, enhanced with mobile health (mHealth) behavior change strategies. Our first aim is to test the feasibility and acceptability, of an 8-week, family-based, multi-level intervention (BMT-Health) to promote PA in young children with ADHD. Our second aim is to derive an estimate of the effect size of the intervention on PA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Enhancement for ADHD Program | Experimental | Behavioral: Lifestyle Enhancement for ADHD ProgramThere is no comparison/control arm. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- age 5-10 years
- ADHD diagnosis
- CGI-S rating >4 and <7
- Per caregiver report, engage in <60 min/day of MVPA for at least 5 days per week
- One adult caregiver willing to participate in the study and complete baseline/follow-up measures
Key exclusion criteria (4 listed)
- younger than 5 years old or older than 10 years old
- do not meet criteria for ADHD diagnosis
- Meet diagnostic criteria for psychiatric co-morbidities including Autism Spectrum Disorder, Depressive Disorder, Mood Disorder, Psychotic Disorder, or Intellectual Disability that could interfere with intervention uptake
- Per caregiver report, engage in >60 min/day of MVPA for at least 5 days per week
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 |
|---|---|---|
| Lifestyle Enhancement for ADHD ProgramAlso: LEAPThe LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting. | Behavioural | Lifestyle Enhancement for ADHD Program |
Primary outcome
Moderate to Vigorous Physical Activity (MVPA)
Time frame: Baseline (measured prior to week 1 of Treatment Group) and week 9
Measured by accelerometer worn by participating children
Garmin Wear Time
Time frame: Weeks 1 - 9
The length of time (in days) each participant wore the Garmin device as a measure of feasibility
Number of Facebook Posts
Time frame: Weeks 1 - 9
The amount of contribution to the Facebook page (comments, likes, etc) by each participant is a measure of feasibility
Number of Caregivers With Attendance at the Focus Group
Time frame: Week 9
Attendance will be taken at the focus group as a measure of study acceptability
10 secondary outcomes
Stop Signal Reaction Time (SSRT) Task Score
Time frame: Baseline to week 9
Digit Span (DS) Task - Total Score
Time frame: Baseline to week 9
Finger Windows (FW) Task
Time frame: Change between baseline and week 9
Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: Change between baseline and week 9
Impairment Rating Scale (IRS)
Time frame: Change between baseline and week 9
Alabama Parenting Questionnaire (APQ)
Time frame: Change between baseline and week 9
Health Behaviors Survey
Time frame: Baseline and week 9
Child's Sleep Habits Questionnaire (Pre-school and School-aged Children)
Time frame: Baseline and week 9
Conners-3 Questionnaire
Time frame: Change between baseline and week 9
Teacher Vanderbilt
Time frame: Baseline and week 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for ADHD
Not yet recruitingObservational study
Phase 1: Thrive Together: A Feasibility and Acceptability Evaluation of Peer Mentoring for High Schoolers With ADHD and Their Caregivers
Attention-Deficit/Hyperactivity Disorder (ADHD)
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Active, not recruiting
Parent-Educator Action Response
Attention Deficit and Disruptive Behavior Disorders
RecruitingPhase 3
A Long-term Trial of EB-1020 in Adult Patients With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
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.
Pooja Tandon, MD principal investigator
Seattle Children's Hospital
Erin Gonzalez, MD principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Enhancement for ADHD Program in people with ADHD, run by Seattle Children's Hospital 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 8 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 21 Apr 2022. 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?
Yes. Results are posted in the registry (first posted 21 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Moderate to Vigorous Physical Activity (MVPA) (time frame: Baseline (measured prior to week 1 of Treatment Group) and week 9). 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 21 Apr 2022.