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Lifestyle Enhancement for ADHD Program

Lifestyle Enhancement for ADHD Program

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03690674
Acronym
LEAP
Enrollment
35
Registered
2018-10-01
Start date
2018-11-15
Completion date
2020-01-21
Last updated
2022-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

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

BEHAVIORALLifestyle 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.

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Seattle Children's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Moderate to Vigorous Physical Activity (MVPA)Baseline (measured prior to week 1 of Treatment Group) and week 9Measured by accelerometer worn by participating children
Garmin Wear TimeWeeks 1 - 9The length of time (in days) each participant wore the Garmin device as a measure of feasibility
Number of Facebook PostsWeeks 1 - 9The 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 GroupWeek 9Attendance will be taken at the focus group as a measure of study acceptability

Secondary

MeasureTime frameDescription
Impairment Rating Scale (IRS)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.
Alabama Parenting Questionnaire (APQ)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.
Health Behaviors SurveyBaseline and week 9Measure 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 ScoreBaseline to week 9Measure of executive function completed by the child. Score is time in ms for participant to respond. Lower score is better.
Conners-3 QuestionnaireChange between baseline and week 9Measure 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 VanderbiltBaseline and week 9Pre 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 9The 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 ScoreBaseline to week 9Measure of executive function completed by the child. Digit Span Task. Minimum score: 0; Maximum score: 54. Higher score is better outcome.
Finger Windows (FW) TaskChange between baseline and week 9Measure of executive function completed by the child
Behavior Rating Inventory of Executive Function (BRIEF)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.

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

ArmCount
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
Total33

Baseline characteristics

CharacteristicLifestyle Enhancement for ADHD Program
Age, Continuous7.6 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 typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 350 / 35
other
Total, other adverse events
1 / 352 / 35
serious
Total, serious adverse events
0 / 350 / 35

Outcome results

Primary

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.

ArmMeasureValue (MEAN)Dispersion
Lifestyle Enhancement for ADHD ProgramGarmin Wear Time49.18 DaysStandard Deviation 14.96
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Lifestyle Enhancement for ADHD ProgramModerate to Vigorous Physical Activity (MVPA)Baseline (prior to week 1) MVPA53.1 Moderate-Vigorous Minutes per dayStandard Deviation 27.7
Lifestyle Enhancement for ADHD ProgramModerate to Vigorous Physical Activity (MVPA)Week 9 MVPA51.8 Moderate-Vigorous Minutes per dayStandard Deviation 24.4
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Lifestyle Enhancement for ADHD ProgramNumber of Caregivers With Attendance at the Focus Group29 Participants
Primary

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.

ArmMeasureValue (MEAN)Dispersion
Lifestyle Enhancement for ADHD ProgramNumber of Facebook Posts7.91 Facebook PostsStandard Deviation 18.92
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.

Time frame: Change between baseline and week 9

ArmMeasureGroupValue (MEAN)Dispersion
Lifestyle Enhancement for ADHD ProgramAlabama Parenting Questionnaire (APQ)Pre23.3 score on a scaleStandard Deviation 2.48
Lifestyle Enhancement for ADHD ProgramAlabama Parenting Questionnaire (APQ)Post22.6 score on a scaleStandard Deviation 2.24
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.

Time frame: Change between baseline and week 9

ArmMeasureGroupValue (MEAN)Dispersion
Lifestyle Enhancement for ADHD ProgramBehavior Rating Inventory of Executive Function (BRIEF)Pre71.7 T-ScoreStandard Deviation 8.69859
Lifestyle Enhancement for ADHD ProgramBehavior Rating Inventory of Executive Function (BRIEF)Post68.4 T-ScoreStandard Deviation 8.00259
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.

Time frame: Baseline and week 9

Population: 24 participants that completed measure at both timepoints.

ArmMeasureGroupValue (MEAN)Dispersion
Lifestyle Enhancement for ADHD ProgramChild's Sleep Habits Questionnaire (Pre-school and School-aged Children)Pre47 units on a scaleStandard Deviation 9.371557339
Lifestyle Enhancement for ADHD ProgramChild's Sleep Habits Questionnaire (Pre-school and School-aged Children)Post44 units on a scaleStandard Deviation 7.541191233
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.

Time frame: Change between baseline and week 9

Population: 28 participants that completed measure at both timepoints.

ArmMeasureGroupValue (MEAN)Dispersion
Lifestyle Enhancement for ADHD ProgramConners-3 QuestionnaireConnors Inattention - PRE78.71 Score on a scaleStandard Error 11.346
Lifestyle Enhancement for ADHD ProgramConners-3 QuestionnaireConnors Inattention - POST75.75 Score on a scaleStandard Error 9.721
Lifestyle Enhancement for ADHD ProgramConners-3 QuestionnaireConnors - Hyperactivity/Impulsivity - PRE74.89 Score on a scaleStandard Error 12.968
Lifestyle Enhancement for ADHD ProgramConners-3 QuestionnaireConnors - Hyperactivity/Impulsivity - POST71.68 Score on a scaleStandard Error 11.898
Lifestyle Enhancement for ADHD ProgramConners-3 QuestionnaireConnors Aggression/Defiance - PRE69.21 Score on a scaleStandard Error 16.601
Lifestyle Enhancement for ADHD ProgramConners-3 QuestionnaireConnors Aggression/Defiance - POST63.21 Score on a scaleStandard Error 14.444
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.

Time frame: Baseline to week 9

Population: 29 children completed this assessment at both pre and post timepoints

ArmMeasureGroupValue (MEAN)Dispersion
Lifestyle Enhancement for ADHD ProgramDigit Span (DS) Task - Total ScorePre9.9 score on a scaleStandard Deviation 3.177
Lifestyle Enhancement for ADHD ProgramDigit Span (DS) Task - Total ScorePost10.31 score on a scaleStandard Deviation 2.753
Secondary

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.

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.

Time frame: Baseline and week 9

Population: 29 participants that completed measure at both timepoints.

ArmMeasureGroupValue (NUMBER)
Lifestyle Enhancement for ADHD ProgramHealth Behaviors SurveyHBS item - Needs 1:1 supervision - (POST)4 participants
Lifestyle Enhancement for ADHD ProgramHealth Behaviors SurveyHBS Item - Needs 1:1 supervision (Pre)13 participants
Lifestyle Enhancement for ADHD ProgramHealth Behaviors SurveyHBS Item - Doesn't do well in a group - PRE7 participants
Lifestyle Enhancement for ADHD ProgramHealth Behaviors SurveyHBS Item - Doesn't do well in a group - POST4 participants
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.

Time frame: Change between baseline and week 9

ArmMeasureGroupValue (MEAN)Dispersion
Lifestyle Enhancement for ADHD ProgramImpairment Rating Scale (IRS)Pre72.2414 score on a scaleStandard Deviation 18.13374
Lifestyle Enhancement for ADHD ProgramImpairment Rating Scale (IRS)Post64.7586 score on a scaleStandard Deviation 18.10417
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.

Time frame: Baseline to week 9

Population: 28 participant children completed this task.

ArmMeasureGroupValue (MEAN)Dispersion
Lifestyle Enhancement for ADHD ProgramStop Signal Reaction Time (SSRT) Task ScorePre240.4285714 millisecondsStandard Deviation 59.77019483
Lifestyle Enhancement for ADHD ProgramStop Signal Reaction Time (SSRT) Task ScorePost244.8214286 millisecondsStandard Deviation 69.76258871
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.

Time frame: Baseline and week 9

Population: 33 teachers that reported according to their experience with participant in their class.

ArmMeasureGroupValue (MEAN)Dispersion
Lifestyle Enhancement for ADHD ProgramTeacher VanderbiltVanderbilt Inattention - teacher-report - PRE4.91 symptomsStandard Deviation 3.263
Lifestyle Enhancement for ADHD ProgramTeacher VanderbiltVanderbilt Inattention - teacher-report - POST3.61 symptomsStandard Deviation 2.989
Lifestyle Enhancement for ADHD ProgramTeacher VanderbiltVanderbilt Hyperactive/Impulsive - teacher-report - PRE3.67 symptomsStandard Deviation 3.266
Lifestyle Enhancement for ADHD ProgramTeacher VanderbiltVanderbilt Hyperactive/Impulsive - teacher-report - POST2.64 symptomsStandard Deviation 2.988

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026