ADHD
Conditions
Keywords
ADHD, Physical Activity, Behavioral Management Training, Mobile Health
Brief 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.
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.
Interventions
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Moderate to Vigorous Physical Activity (MVPA) | Baseline (measured prior to week 1 of Treatment Group) and week 9 | Measured by accelerometer worn by participating children |
| Garmin Wear Time | Weeks 1 - 9 | The length of time (in days) each participant wore the Garmin device as a measure of feasibility |
| Number of Facebook Posts | 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 | Week 9 | Attendance will be taken at the focus group as a measure of study acceptability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impairment Rating Scale (IRS) | Change between baseline and week 9 | 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. |
| Alabama Parenting Questionnaire (APQ) | Change between baseline and week 9 | 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. |
| Health Behaviors Survey | Baseline and week 9 | 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. |
| Stop Signal Reaction Time (SSRT) Task Score | Baseline to week 9 | Measure of executive function completed by the child. Score is time in ms for participant to respond. Lower score is better. |
| Conners-3 Questionnaire | Change between baseline and week 9 | 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. |
| Teacher Vanderbilt | Baseline and week 9 | 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. |
| Child's Sleep Habits Questionnaire (Pre-school and School-aged Children) | Baseline and week 9 | 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. |
| Digit Span (DS) Task - Total Score | Baseline to week 9 | Measure of executive function completed by the child. Digit Span Task. Minimum score: 0; Maximum score: 54. Higher score is better outcome. |
| Finger Windows (FW) Task | Change between baseline and week 9 | Measure of executive function completed by the child |
| Behavior Rating Inventory of Executive Function (BRIEF) | Change between baseline and week 9 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Lifestyle Enhancement for ADHD Program |
|---|---|
| Age, Continuous | 7.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 1 / 35 | 2 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Garmin Wear Time
The length of time (in days) each participant wore the Garmin device as a measure of feasibility
Time frame: Weeks 1 - 9
Population: 66 participants (33 dyads) who wore the Garmin devices.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Enhancement for ADHD Program | Garmin Wear Time | 49.18 Days | Standard Deviation 14.96 |
Moderate to Vigorous Physical Activity (MVPA)
Measured by accelerometer worn by participating children
Time frame: Baseline (measured prior to week 1 of Treatment Group) and week 9
Population: Only child participants wore the accelerometer. Number analyzed at post reflects participants who withdrew from study and/or did not complete this measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Enhancement for ADHD Program | Moderate to Vigorous Physical Activity (MVPA) | Baseline (prior to week 1) MVPA | 53.1 Moderate-Vigorous Minutes per day | Standard Deviation 27.7 |
| Lifestyle Enhancement for ADHD Program | Moderate to Vigorous Physical Activity (MVPA) | Week 9 MVPA | 51.8 Moderate-Vigorous Minutes per day | Standard Deviation 24.4 |
Number of Caregivers With Attendance at the Focus Group
Attendance will be taken at the focus group as a measure of study acceptability
Time frame: Week 9
Population: 33 dyads were still enrolled and participating at this timepoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lifestyle Enhancement for ADHD Program | Number of Caregivers With Attendance at the Focus Group | 29 Participants |
Number of Facebook Posts
The amount of contribution to the Facebook page (comments, likes, etc) by each participant is a measure of feasibility
Time frame: Weeks 1 - 9
Population: 33 caregivers (children were not part of the Facebook groups). 2 dyads dropped out of the study after consent and before group started.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Enhancement for ADHD Program | Number of Facebook Posts | 7.91 Facebook Posts | Standard Deviation 18.92 |
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.
Time frame: Change between baseline and week 9
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Enhancement for ADHD Program | Alabama Parenting Questionnaire (APQ) | Pre | 23.3 score on a scale | Standard Deviation 2.48 |
| Lifestyle Enhancement for ADHD Program | Alabama Parenting Questionnaire (APQ) | Post | 22.6 score on a scale | Standard Deviation 2.24 |
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.
Time frame: Change between baseline and week 9
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Enhancement for ADHD Program | Behavior Rating Inventory of Executive Function (BRIEF) | Pre | 71.7 T-Score | Standard Deviation 8.69859 |
| Lifestyle Enhancement for ADHD Program | Behavior Rating Inventory of Executive Function (BRIEF) | Post | 68.4 T-Score | Standard Deviation 8.00259 |
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.
Time frame: Baseline and week 9
Population: 24 participants that completed measure at both timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Enhancement for ADHD Program | Child's Sleep Habits Questionnaire (Pre-school and School-aged Children) | Pre | 47 units on a scale | Standard Deviation 9.371557339 |
| Lifestyle Enhancement for ADHD Program | Child's Sleep Habits Questionnaire (Pre-school and School-aged Children) | Post | 44 units on a scale | Standard Deviation 7.541191233 |
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.
Time frame: Change between baseline and week 9
Population: 28 participants that completed measure at both timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Enhancement for ADHD Program | Conners-3 Questionnaire | Connors Inattention - PRE | 78.71 Score on a scale | Standard Error 11.346 |
| Lifestyle Enhancement for ADHD Program | Conners-3 Questionnaire | Connors Inattention - POST | 75.75 Score on a scale | Standard Error 9.721 |
| Lifestyle Enhancement for ADHD Program | Conners-3 Questionnaire | Connors - Hyperactivity/Impulsivity - PRE | 74.89 Score on a scale | Standard Error 12.968 |
| Lifestyle Enhancement for ADHD Program | Conners-3 Questionnaire | Connors - Hyperactivity/Impulsivity - POST | 71.68 Score on a scale | Standard Error 11.898 |
| Lifestyle Enhancement for ADHD Program | Conners-3 Questionnaire | Connors Aggression/Defiance - PRE | 69.21 Score on a scale | Standard Error 16.601 |
| Lifestyle Enhancement for ADHD Program | Conners-3 Questionnaire | Connors Aggression/Defiance - POST | 63.21 Score on a scale | Standard Error 14.444 |
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.
Time frame: Baseline to week 9
Population: 29 children completed this assessment at both pre and post timepoints
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Enhancement for ADHD Program | Digit Span (DS) Task - Total Score | Pre | 9.9 score on a scale | Standard Deviation 3.177 |
| Lifestyle Enhancement for ADHD Program | Digit Span (DS) Task - Total Score | Post | 10.31 score on a scale | Standard Deviation 2.753 |
Finger Windows (FW) Task
Measure of executive function completed by the child
Time frame: Change between baseline and week 9
Population: This task was not utilized during the study due to study team decision due to time consideration and burden on participants.
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.
Time frame: Baseline and week 9
Population: 29 participants that completed measure at both timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lifestyle Enhancement for ADHD Program | Health Behaviors Survey | HBS item - Needs 1:1 supervision - (POST) | 4 participants |
| Lifestyle Enhancement for ADHD Program | Health Behaviors Survey | HBS Item - Needs 1:1 supervision (Pre) | 13 participants |
| Lifestyle Enhancement for ADHD Program | Health Behaviors Survey | HBS Item - Doesn't do well in a group - PRE | 7 participants |
| Lifestyle Enhancement for ADHD Program | Health Behaviors Survey | HBS Item - Doesn't do well in a group - POST | 4 participants |
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.
Time frame: Change between baseline and week 9
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Enhancement for ADHD Program | Impairment Rating Scale (IRS) | Pre | 72.2414 score on a scale | Standard Deviation 18.13374 |
| Lifestyle Enhancement for ADHD Program | Impairment Rating Scale (IRS) | Post | 64.7586 score on a scale | Standard Deviation 18.10417 |
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.
Time frame: Baseline to week 9
Population: 28 participant children completed this task.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Enhancement for ADHD Program | Stop Signal Reaction Time (SSRT) Task Score | Pre | 240.4285714 milliseconds | Standard Deviation 59.77019483 |
| Lifestyle Enhancement for ADHD Program | Stop Signal Reaction Time (SSRT) Task Score | Post | 244.8214286 milliseconds | Standard Deviation 69.76258871 |
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.
Time frame: Baseline and week 9
Population: 33 teachers that reported according to their experience with participant in their class.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Enhancement for ADHD Program | Teacher Vanderbilt | Vanderbilt Inattention - teacher-report - PRE | 4.91 symptoms | Standard Deviation 3.263 |
| Lifestyle Enhancement for ADHD Program | Teacher Vanderbilt | Vanderbilt Inattention - teacher-report - POST | 3.61 symptoms | Standard Deviation 2.989 |
| Lifestyle Enhancement for ADHD Program | Teacher Vanderbilt | Vanderbilt Hyperactive/Impulsive - teacher-report - PRE | 3.67 symptoms | Standard Deviation 3.266 |
| Lifestyle Enhancement for ADHD Program | Teacher Vanderbilt | Vanderbilt Hyperactive/Impulsive - teacher-report - POST | 2.64 symptoms | Standard Deviation 2.988 |