Lifestyle Enhancement for ADHD Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Number of Facebook Posts
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of Facebook Posts
时间窗: 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
时间窗: Week 9
Attendance will be taken at the focus group as a measure of study acceptability
Garmin Wear Time
时间窗: Weeks 1 - 9
The length of time (in days) each participant wore the Garmin device as a measure of feasibility
Moderate to Vigorous Physical Activity (MVPA)
时间窗: Baseline (measured prior to week 1 of Treatment Group) and week 9
Measured by accelerometer worn by participating children
次要结局
- Alabama Parenting Questionnaire (APQ)(Change between baseline and week 9)
- Stop Signal Reaction Time (SSRT) Task Score(Baseline to week 9)
- Behavior Rating Inventory of Executive Function (BRIEF)(Change between baseline and week 9)
- Health Behaviors Survey(Baseline and week 9)
- Finger Windows (FW) Task(Change between baseline and week 9)
- Digit Span (DS) Task - Total Score(Baseline to week 9)
- Impairment Rating Scale (IRS)(Change between baseline and week 9)
- Child's Sleep Habits Questionnaire (Pre-school and School-aged Children)(Baseline and week 9)
- Conners-3 Questionnaire(Change between baseline and week 9)
- Teacher Vanderbilt(Baseline and week 9)
研究者
Pooja Tandon
Assistant Professor
Seattle Children's Hospital