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| ID | Type | Description | Link |
|---|---|---|---|
| R21AT010041-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Enhancement for ADHD Program | Experimental | There is no comparison/control arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Enhancement for ADHD Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Moderate to Vigorous Physical Activity (MVPA) | Measured by accelerometer worn by participating children | 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 | 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 | 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 | Week 9 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to week 9 |
| Digit Span (DS) Task - Total Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pooja Tandon, MD | Seattle Children's Hospital | Principal Investigator |
| Erin Gonzalez, MD | Seattle Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Research Institute | Seattle | Washington | 98145 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline Population Description is based on the number of parents that began treatment group. 35 were initially enrolled (provided consent), but 2 withdrew before treatment groups began.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Moderate to Vigorous Physical Activity (MVPA) | Measured by accelerometer worn by participating children | Only child participants wore the accelerometer. Number analyzed at post reflects participants who withdrew from study and/or did not complete this measurement. | Posted | Mean | Standard Deviation | Moderate-Vigorous Minutes per day | Baseline (measured prior to week 1 of Treatment Group) and week 9 |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Concussion | Injury, poisoning and procedural complications | Non-systematic Assessment | Mother received a concussion due to accident unrelated to study participation. She missed a group session and had a self-reported decline in physical activity due to her accident. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pooja Tandon | Seattle Children's Research Institute | 206-884-1130 | pooja.tandon@seattlechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2019 | Jul 4, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 14, 2019 | Jan 20, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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Measure of executive function completed by the child. Digit Span Task. Minimum score: 0; Maximum score: 54. Higher score is better outcome.
| Baseline to week 9 |
| Finger Windows (FW) Task | Measure of executive function completed by the child | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline and week 9 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Garmin Wear Time | The length of time (in days) each participant wore the Garmin device as a measure of feasibility | 66 participants (33 dyads) who wore the Garmin devices. | Posted | Mean | Standard Deviation | Days | Weeks 1 - 9 |
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| Primary | Number of Facebook Posts | The amount of contribution to the Facebook page (comments, likes, etc) by each participant is a measure of feasibility | 33 caregivers (children were not part of the Facebook groups). 2 dyads dropped out of the study after consent and before group started. | Posted | Mean | Standard Deviation | Facebook Posts | Weeks 1 - 9 |
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| Primary | Number of Caregivers With Attendance at the Focus Group | Attendance will be taken at the focus group as a measure of study acceptability | 33 dyads were still enrolled and participating at this timepoint. | Posted | Count of Participants | Participants | Week 9 |
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| Secondary | 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. | 28 participant children completed this task. | Posted | Mean | Standard Deviation | milliseconds | Baseline to week 9 |
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| Secondary | 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. | 29 children completed this assessment at both pre and post timepoints | Posted | Mean | Standard Deviation | score on a scale | Baseline to week 9 |
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| Secondary | Finger Windows (FW) Task | Measure of executive function completed by the child | This task was not utilized during the study due to study team decision due to time consideration and burden on participants. | Posted | Change between baseline and week 9 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | T-Score | Change between baseline and week 9 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Change between baseline and week 9 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Change between baseline and week 9 |
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| Secondary | 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. | 29 participants that completed measure at both timepoints. | Posted | Number | participants | Baseline and week 9 |
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| Secondary | 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. | 24 participants that completed measure at both timepoints. | Posted | Mean | Standard Deviation | units on a scale | Baseline and week 9 |
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| Secondary | 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. | 28 participants that completed measure at both timepoints. | Posted | Mean | Standard Error | Score on a scale | Change between baseline and week 9 |
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| Secondary | 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. | 33 teachers that reported according to their experience with participant in their class. | Posted | Mean | Standard Deviation | symptoms | Baseline and week 9 |
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| 0 |
| 35 |
| 0 |
| 35 |
| 1 |
| 35 |
| EG001 | 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. | 0 | 35 | 0 | 35 | 2 | 35 |
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| Stomach Flu | Gastrointestinal disorders | Non-systematic Assessment | 2 children were reported per parents of having contracted the stomach flu. All recovered within 3-4 days. |
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| Title | Measurements |
|---|---|
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| HBS Item - Doesn't do well in a group - POST |
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| Connors - Hyperactivity/Impulsivity - POST |
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| Connors Aggression/Defiance - PRE |
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| Connors Aggression/Defiance - POST |
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| Vanderbilt Hyperactive/Impulsive - teacher-report - POST |
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