Lifestyle Enhancement for ADHD Program (LEAP) Study 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Effects of intervention on Physical Activity
研究概览
简要总结
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 caregivers, enhanced with mobile health (mHealth) behavior change strategies.
Primary Objective: To evaluate the primary effects of a 9-week, family-based intervention (Lifestyle Enhancement for ADHD Program - LEAP) to promote PA in young children with ADHD
Secondary: To evaluate secondary effects of the LEAP program on child ADHD symptoms and executive functioning
详细描述
This is a randomized trial comparing the LEAP program to standard BMT for ADHD (without the enhanced focus on health behaviors, mHealth technology, or social media). Specifically, 80 families will be randomized to receive either LEAP or a standard BMT program based on Russell Barkley's Defiant Children intervention manual. Moderators (e.g., child sex, medication, BMI) and mediators (e.g., change in PA) will be analyzed as exploratory outcomes. Hypotheses being tested include: 1) LEAP will be successful in increasing PA in children with ADHD in the short-term and over a year, more so than standard BPT and 2) children randomized to LEAP will exhibit greater and more sustained improvement in clinical outcomes relative to standard BMT. If successful, the R33 phase will inform the development of a larger and longer, confirmatory trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 6-10 years
- •ADHD diagnosis
- •CGI-S rating ranging from 4 to
- •Child not wearing a wrist-worn activity tracker more than 50% of days in the past month
- •Inclusion Criteria (caregiver):
- •One adult custodial caregiver (resides with the child at least 50% of the time) 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
- •Inclusion Criteria (supplementary caregiver):
- •An additional caregiver designated by the participating caregiver who provides care for the participating child on at least one occasion every other week
- •Able to participate in one or more group sessions
- •Able to consent in English
排除标准
- •(children):
- •- Younger than 6 years old or older than 10 years old
- •Do not meet criteria currently for ADHD diagnosis
- •Meet diagnostic criteria for psychiatric co-morbidities of Autism Spectrum Disorder, Depressive Disorder, Mood Disorder, Psychotic Disorder, or Intellectual Disability (by history)
- •Per caregiver report, engage in >60 min/day of MVPA consistently for at least 5 days per week
- •Any physical or medical restrictions on PA
- •Child currently/previously used a wearable physical activity sensing device at least 50% of days in the past month
- •Exclusion Criteria (caregiver):
- •Caregiver participated in an evidence-based parent behavior management training program (i.e., Incredible Years, Triple P, PCIT, Barkley's Defiant Child) in the past 24 months.
- •Exclusion Criteria (supplementary caregiver): none
研究组 & 干预措施
LEAP Group
In addition to the components of the BMT group, the LEAP program includes an emphasis on supporting optimal physical activity, limiting screen time, and encouraging adequate sleep. The child and caregiver are also given a wrist-worn activity tracker and caregivers participate in a motivational Facebook group.
干预措施: LEAP (Behavioral)
BMT Group
The BMT Group will take part in a family-based intervention within the context of evidence-based behavioral management training (BMT) for caregivers. Standard BMT represents the current standard of care for childhood ADHD.
干预措施: Standard BMT (Behavioral)
结局指标
主要结局
Effects of intervention on Physical Activity
时间窗: Baseline to 1 year
Comparing within-subject pre to post activity (MVPA) using accelerometer data
Effects of intervention on Physical Activity
时间窗: Baseline to 10 weeks
Comparing within-subject pre to post activity (MVPA) using accelerometer data
Effects of intervention on Physical Activity
时间窗: Baseline to 20 weeks
Comparing within-subject pre to post activity (MVPA) using accelerometer data
次要结局
- Effects of LEAP participation on child ADHD symptoms(Baseline to 1 year)
- Effects of LEAP participation on child executive function(Baseline to 1 year)
- Effects of LEAP participation on child executive function(Baseline to 10 weeks)
- Effects of LEAP participation on child executive function(Baseline to 20 weeks)
- Effects of LEAP participation on child ADHD symptoms(Baseline to 10 weeks)
- Effects of LEAP participation on child ADHD symptoms(Baseline to 20 weeks)
研究者
Pooja Tandon
Principal Investigator
Seattle Children's Hospital