Executive Function Enhanced Parent-Based Treatment for Children With ADHD and Overweight or Obesity
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility as measured by number of treatment sessions attended
研究概览
简要总结
The pilot study will be a one group open-label treatment program and will be used to refine a parent-based behavioral treatment enhanced with executive-function training (PBT-EF) for children with comorbid overweight or obesity and Attention-Deficit Hyperactivity Disorder (ADHD).
详细描述
The currently recommended treatment for children with overweight or obesity (OW/OB), family-based behavioral treatment (FBT), results in sustained weight loss for only 1/3 of children. Attention-Deficit Hyperactivity Disorder (ADHD) is one of the most common neurobehavioral disorders in children and is characterized by difficulties in Executive Function (EF). Substantial research suggests higher rates of OW/OB in children with ADHD; thus, children with OW/OB and ADHD are likely to have greater difficulties with EF and achieving success in FBT. The proposed study aims to develop a parent-based behavioral treatment enhanced with EF training (PBT-EF) to improve treatment outcomes for children with comorbid OW/OB and ADHD. The treatment will be administered to parents in 18 group sessions over 5 months. Parents and children will be assessed at baseline, post-treatment, and 3-month follow-up. Assessments will include body mass index (BMI), assessments of executive function, and behavioral questionnaires. This study could provide a novel model to treat OW/OB in children with ADHD, and could inform clinical decision making regarding obesity treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child with overweight or obesity (85-99.9% BMI for age),
- •Child age 8-12,
- •Child with a diagnosis of ADHD,
- •A parent willing to participate who can read and understand English at a minimum of a fifth-grade level, able to attend treatment sessions remotely via Zoom on video.
排除标准
- •Current enrollment in an organized weight control program (parent and child)
- •Medication specifically prescribed for weight loss (child)
- •Medical or psychiatric condition that may interfere with treatment participation or that may require physician monitoring of diet and/or exercise (e.g., acute suicidality; psychosis; substance use disorder) (parent and child)
- •Change in psychotropic medication or other medication that may impact weight or ADHD symptoms during the previous 3 months (child)
研究组 & 干预措施
Executive Function-Enhanced Parent-Based Behavioral Treatment (PBT-EF)
PBT-EF will integrate executive function training with family-based behavioral treatment (FBT) for obesity, the gold-standard behavioral treatment for childhood obesity. PBT-EF will include self-monitoring, calorie reduction, and dietary and physical activity recommendations in addition to planning, organization, and problem-solving skills.
干预措施: PBT-EF (Behavioral)
结局指标
主要结局
Feasibility as measured by number of treatment sessions attended
时间窗: Over the course of 5 months of treatment
Attendance at Treatment Sessions
Acceptability
时间窗: At 5 months
Ratings of usefulness of treatment
次要结局
未报告次要终点
研究者
Dawn Eichen
Assistant Professor
University of California, San Diego