Trial Outcomes & Findings for Lifestyle Enhancement for ADHD Program (NCT NCT03690674)
NCT ID: NCT03690674
Last Updated: 2022-04-21
Results Overview
Measured by accelerometer worn by participating children
COMPLETED
NA
35 participants
Baseline (measured prior to week 1 of Treatment Group) and week 9
2022-04-21
Participant Flow
70 participants consisting of 35 dyads (caregver+child) were initially enrolled in the study. 2 dyads withdrew from the study before the group treatment sessions began.
Participant milestones
| Measure |
Caregivers - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lifestyle Enhancement for ADHD Program
Baseline characteristics by cohort
| Measure |
Lifestyle Enhancement for ADHD Program
n=33 Participants
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
|---|---|
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Age, Continuous
|
7.6 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Baseline (measured prior to week 1 of Treatment Group) and week 9Population: Only child participants wore the accelerometer. Number analyzed at post reflects participants who withdrew from study and/or did not complete this measurement.
Measured by accelerometer worn by participating children
Outcome measures
| Measure |
Lifestyle Enhancement for ADHD Program
n=34 Participants
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
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|---|---|---|
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Moderate to Vigorous Physical Activity (MVPA)
Baseline (prior to week 1) MVPA
|
53.1 Moderate-Vigorous Minutes per day
Standard Deviation 27.7
|
—
|
|
Moderate to Vigorous Physical Activity (MVPA)
Week 9 MVPA
|
51.8 Moderate-Vigorous Minutes per day
Standard Deviation 24.4
|
—
|
PRIMARY outcome
Timeframe: Weeks 1 - 9Population: 66 participants (33 dyads) who wore the Garmin devices.
The length of time (in days) each participant wore the Garmin device as a measure of feasibility
Outcome measures
| Measure |
Lifestyle Enhancement for ADHD Program
n=66 Participants
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
|---|---|---|
|
Garmin Wear Time
|
49.18 Days
Standard Deviation 14.96
|
—
|
PRIMARY outcome
Timeframe: Weeks 1 - 9Population: 33 caregivers (children were not part of the Facebook groups). 2 dyads dropped out of the study after consent and before group started.
The amount of contribution to the Facebook page (comments, likes, etc) by each participant is a measure of feasibility
Outcome measures
| Measure |
Lifestyle Enhancement for ADHD Program
n=33 Participants
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
|---|---|---|
|
Number of Facebook Posts
|
7.91 Facebook Posts
Standard Deviation 18.92
|
—
|
PRIMARY outcome
Timeframe: Week 9Population: 33 dyads were still enrolled and participating at this timepoint.
Attendance will be taken at the focus group as a measure of study acceptability
Outcome measures
| Measure |
Lifestyle Enhancement for ADHD Program
n=33 Participants
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
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|---|---|---|
|
Number of Caregivers With Attendance at the Focus Group
|
29 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 9Population: 28 participant children completed this task.
Measure of executive function completed by the child. Score is time in ms for participant to respond. Lower score is better.
Outcome measures
| Measure |
Lifestyle Enhancement for ADHD Program
n=28 Participants
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
|---|---|---|
|
Stop Signal Reaction Time (SSRT) Task Score
Pre
|
240.4285714 milliseconds
Standard Deviation 59.77019483
|
—
|
|
Stop Signal Reaction Time (SSRT) Task Score
Post
|
244.8214286 milliseconds
Standard Deviation 69.76258871
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 9Population: 29 children completed this assessment at both pre and post timepoints
Measure of executive function completed by the child. Digit Span Task. Minimum score: 0; Maximum score: 54. Higher score is better outcome.
Outcome measures
| Measure |
Lifestyle Enhancement for ADHD Program
n=29 Participants
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
|---|---|---|
|
Digit Span (DS) Task - Total Score
Pre
|
9.9 score on a scale
Standard Deviation 3.177
|
—
|
|
Digit Span (DS) Task - Total Score
Post
|
10.31 score on a scale
Standard Deviation 2.753
|
—
|
SECONDARY outcome
Timeframe: Change between baseline and week 9Population: This task was not utilized during the study due to study team decision due to time consideration and burden on participants.
Measure of executive function completed by the child
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change between baseline and week 9Measure 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.
Outcome measures
| Measure |
Lifestyle Enhancement for ADHD Program
n=30 Participants
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
|---|---|---|
|
Behavior Rating Inventory of Executive Function (BRIEF)
Pre
|
71.7 T-Score
Standard Deviation 8.69859
|
—
|
|
Behavior Rating Inventory of Executive Function (BRIEF)
Post
|
68.4 T-Score
Standard Deviation 8.00259
|
—
|
SECONDARY outcome
Timeframe: Change between baseline and week 9Measure 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.
Outcome measures
| Measure |
Lifestyle Enhancement for ADHD Program
n=29 Participants
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
|---|---|---|
|
Impairment Rating Scale (IRS)
Pre
|
72.2414 score on a scale
Standard Deviation 18.13374
|
—
|
|
Impairment Rating Scale (IRS)
Post
|
64.7586 score on a scale
Standard Deviation 18.10417
|
—
|
SECONDARY outcome
Timeframe: Change between baseline and week 9Measure 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.
Outcome measures
| Measure |
Lifestyle Enhancement for ADHD Program
n=30 Participants
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
|---|---|---|
|
Alabama Parenting Questionnaire (APQ)
Pre
|
23.3 score on a scale
Standard Deviation 2.48
|
—
|
|
Alabama Parenting Questionnaire (APQ)
Post
|
22.6 score on a scale
Standard Deviation 2.24
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 9Population: 29 participants that completed measure at both timepoints.
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.
Outcome measures
| Measure |
Lifestyle Enhancement for ADHD Program
n=29 Participants
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
|---|---|---|
|
Health Behaviors Survey
HBS Item - Needs 1:1 supervision (Pre)
|
13 participants
|
—
|
|
Health Behaviors Survey
HBS item - Needs 1:1 supervision - (POST)
|
4 participants
|
—
|
|
Health Behaviors Survey
HBS Item - Doesn't do well in a group - PRE
|
7 participants
|
—
|
|
Health Behaviors Survey
HBS Item - Doesn't do well in a group - POST
|
4 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 9Population: 24 participants that completed measure at both timepoints.
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.
Outcome measures
| Measure |
Lifestyle Enhancement for ADHD Program
n=24 Participants
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
|---|---|---|
|
Child's Sleep Habits Questionnaire (Pre-school and School-aged Children)
Pre
|
47 units on a scale
Standard Deviation 9.371557339
|
—
|
|
Child's Sleep Habits Questionnaire (Pre-school and School-aged Children)
Post
|
44 units on a scale
Standard Deviation 7.541191233
|
—
|
SECONDARY outcome
Timeframe: Change between baseline and week 9Population: 28 participants that completed measure at both timepoints.
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.
Outcome measures
| Measure |
Lifestyle Enhancement for ADHD Program
n=28 Participants
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
|---|---|---|
|
Conners-3 Questionnaire
Connors Inattention - PRE
|
78.71 Score on a scale
Standard Error 11.346
|
—
|
|
Conners-3 Questionnaire
Connors Inattention - POST
|
75.75 Score on a scale
Standard Error 9.721
|
—
|
|
Conners-3 Questionnaire
Connors - Hyperactivity/Impulsivity - PRE
|
74.89 Score on a scale
Standard Error 12.968
|
—
|
|
Conners-3 Questionnaire
Connors - Hyperactivity/Impulsivity - POST
|
71.68 Score on a scale
Standard Error 11.898
|
—
|
|
Conners-3 Questionnaire
Connors Aggression/Defiance - PRE
|
69.21 Score on a scale
Standard Error 16.601
|
—
|
|
Conners-3 Questionnaire
Connors Aggression/Defiance - POST
|
63.21 Score on a scale
Standard Error 14.444
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 9Population: 33 teachers that reported according to their experience with participant in their class.
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.
Outcome measures
| Measure |
Lifestyle Enhancement for ADHD Program
n=33 Participants
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
|---|---|---|
|
Teacher Vanderbilt
Vanderbilt Inattention - teacher-report - PRE
|
4.91 symptoms
Standard Deviation 3.263
|
—
|
|
Teacher Vanderbilt
Vanderbilt Inattention - teacher-report - POST
|
3.61 symptoms
Standard Deviation 2.989
|
—
|
|
Teacher Vanderbilt
Vanderbilt Hyperactive/Impulsive - teacher-report - PRE
|
3.67 symptoms
Standard Deviation 3.266
|
—
|
|
Teacher Vanderbilt
Vanderbilt Hyperactive/Impulsive - teacher-report - POST
|
2.64 symptoms
Standard Deviation 2.988
|
—
|
Adverse Events
Caregivers - Lifestyle Enhancement for ADHD Program
Children - Lifestyle Enhancement for ADHD Program
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Caregivers - Lifestyle Enhancement for ADHD Program
n=35 participants at risk
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
Children - Lifestyle Enhancement for ADHD Program
n=35 participants at risk
There is no comparison/control arm.
Lifestyle Enhancement for ADHD Program: 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.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Concussion
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected during the 8 weeks of treatment group. Participants were not monitored/assessed for adverse events outside of the treatment group timeframe.
|
0.00%
0/35 • Adverse event data were collected during the 8 weeks of treatment group. Participants were not monitored/assessed for adverse events outside of the treatment group timeframe.
|
|
Gastrointestinal disorders
Stomach Flu
|
0.00%
0/35 • Adverse event data were collected during the 8 weeks of treatment group. Participants were not monitored/assessed for adverse events outside of the treatment group timeframe.
|
5.7%
2/35 • Number of events 2 • Adverse event data were collected during the 8 weeks of treatment group. Participants were not monitored/assessed for adverse events outside of the treatment group timeframe.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place