Improvement of Planning Skills in Daily Life in Children and Adolescents With ADHD Through a Virtual Reality System: CogFun-RV
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 82
- 主要终点
- Self-assessment of daily time management in children (TIME-S)
研究概览
简要总结
The main aim is to know the effectiveness of a program, CogFun-VR, through the use of immersive virtual reality, to improve executive skills, such as self-regulation, organization, planning and time management in life. of children and adolescents with ADHD, between 9 and 16 years old.
The study design is a randomized clinical trial, with a control group on a waiting list. The estimated sample size is 82 participants: 41 in the experimental group and 41 in the control group.
Participants will be randomly assigned to one of the two groups. Four measurements of the variables of interest will be conducted, in the beginning, after the 12-week duration of the intervention, at 3 months and 6 months as a follow-up. The BRIEF, SNAP-IV, SDQ, EQi: YV and several subtests of the WISC-%, BADS and NEPSY-II will be used. All participants will be assessed by an independent evaluator who will be blinded. The intervention program is manualized to assess its integrity and reliability.
详细描述
Planning skills are one of the difficulties that children with ADHD show, being reflected in four of the nine symptoms of inattention according to the DSM-5. In addition, these skills have been associated with performance in different daily, academic, work and leisure activities.
The main objective of the study is to know the effectiveness of an innovative treatment to improve executive skills, such as planning, organization and time management in daily life in children and adolescents between 9 and 16 years old with a diagnosis of ADHD, through a program multimodal of 12 individual sessions of 75 minutes.
The study design is a randomized clinical trial, with a control group on a waiting list. The estimated number of participants is 82, 41 participants in the experimental group and 41 children in the control group on the waiting list. Participants will be randomly assigned to one of two groups. Three measurements of the variables of interest will be made. All participants will be evaluated by an independent evaluator who will be blinded. The intervention program is manualized in order to assess its integrity and reliability. All sessions are divided into two parts: 1) intervention through an immersive virtual reality system, called COGFUN-RV, lasting 30 minutes and 2) teaching strategies to improve cognitive and emotional self-regulation skills. for another 30 minutes. Each session will include practice, at home or at school, of the strategies learned until the next session. The intervention proposal incorporates 15 minutes of psychoeducation with the parents in each session. The project has been submitted for approval to the Ethics and Human Research Committee of the University of Granada, as well as to the PEIBA. All legal guardians will have to give their informed consent and authorization to participate in the project.
The program represents a novelty in the current treatment for several reasons. First, until now most programs have focused only on basic executive functions, such as working memory, inhibitory control, or cognitive flexibility. Instead, this proposal focuses especially on advanced executive functions, such as planning, organization, time management, and problem solving. Secondly, the main approach is through a virtual reality system, in which the child must plan, manage time, organize the action and regulate its emotions, according to the different actions carried out in the activity. The main characteristic of the virtual proposal is to increase the transfer to daily life and, therefore, the ecological validity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
All participants will be evaluated by an independent evaluator who will be blinded. The statistician will also be blinded, will not participate in the evaluation or intervention. For analysis it will only be revealed as group A or group B. Only when the analyzes have been completed will the exact nature of the groups be revealed.
入排标准
- 年龄范围
- 9 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Self-assessment of daily time management in children (TIME-S)
时间窗: At 6 months
Self-assessment for children with disabilities ages 10-17 ability of time perception, time orientation andknowledge on time management in children 10-17 years old
Weiss Functional Impairment Rating Scale-Parent Form for assessing ADHD
时间窗: At 6 months
The Weiss Functional Impairment Rating Scale- Parent Form (WFIRS-P) is a 50-item scale that assesses functional impairment on six clinically relevant domains typically affected in attention-deficit/hyperactivity disorder (ADHD)
次要结局
- Assessment of Executive Function and Sensory Processing (EPYFEI)(Before and after the intervention (12 weeks))
- Conners Behavior Questionnaire for Parents (SNAP-IV)(Before and after the intervention (12 weeks))
- Emotional intelligence scale EQ-i:Yv(Before and after the intervention (12 weeks))
- Digit test(Before and after the intervention (12 weeks))
- Zoo Map Subtest(Before and after the intervention (12 weeks))
- Stroop Test(Before and after the intervention (12 weeks))
- Trail Making Test(Before and after the intervention (12 weeks))
- Strengths and Difficulties Questionnaire (SDQ)-parents(Before and after the intervention (12 weeks))
研究者
Dulce Romero Ayuso
Principal Investigator
Universidad de Granada
