Clinical trial NCT03690674: Lifestyle Enhancement for ADHD Program
Official title: Lifestyle Enhancement for ADHD Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: ADHD
Physical Activity
Behavioral Management Training
Mobile Health
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2018-10-01
Enrollment: 35
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Moderate to Vigorous Physical Activity (MVPA)
timeFrame: Baseline (measured prior to week 1 of Treatment Group) and week 9
measure: Garmin Wear Time
timeFrame: Weeks 1 - 9
measure: Number of Facebook Posts
timeFrame: Weeks 1 - 9
measure: Number of Caregivers With Attendance at the Focus Group
timeFrame: Week 9
Secondary outcomes:
measure: Stop Signal Reaction Time (SSRT) Task Score
timeFrame: Baseline to week 9
measure: Digit Span (DS) Task - Total Score
timeFrame: Baseline to week 9
measure: Finger Windows (FW) Task
timeFrame: Change between baseline and week 9
measure: Behavior Rating Inventory of Executive Function (BRIEF)
timeFrame: Change between baseline and week 9
measure: Impairment Rating Scale (IRS)
timeFrame: Change between baseline and week 9
measure: Alabama Parenting Questionnaire (APQ)
timeFrame: Change between baseline and week 9
measure: Health Behaviors Survey
timeFrame: Baseline and week 9
measure: Child's Sleep Habits Questionnaire (Pre-school and School-aged Children)
timeFrame: Baseline and week 9
measure: Conners-3 Questionnaire
timeFrame: Change between baseline and week 9
measure: Teacher Vanderbilt
timeFrame: Baseline and week 9
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Research Institute
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Pooja Tandon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seattle Children's Hospital
name: Erin Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
References: