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临床试验/NCT06770725
NCT06770725已完成不适用

Investigating the Effect of the Temporal Adaptation Approach on Activity Self-Efficacy, Time Perception, and Daily Activity Routine with Executive Skills in Children with ADHD: a 1-Month Follow-Up Randomized Controlled Study

Hacettepe University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年2月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Time Perception Threshold Measurement

研究概览

简要总结

This study investigates the impact of temporal adaptation interventions on children with Attention Deficit Hyperactivity Disorder (ADHD), focusing on activity self-efficacy, time perception, daily activity routines, and executive functions. The intervention aims to address the challenges ADHD children face in time processing abilities, which include understanding the concept of time, being punctual, initiating and completing daily activities independently, planning and completing long-term projects, using a calendar, and hurrying when necessary.

The research will be conducted at the Hacettepe University Faculty of Health Sciences Department of Occupational Therapy's educational and research units. Participants will be children diagnosed with ADHD by a Child and Adolescent Psychiatrist. These children will then be randomly assigned to control and training groups. A total of 60 individuals, 30 for each group, will be included in the study based on power analysis. The effectiveness of the study will be shared, and should it prove effective, the same study will be replicated with the control group.

The intervention consists of activities designed to enhance temporal adaptation, adapted for ADHD from models in the literature. Over 10 weeks, the children will engage in weekly 60-minute sessions, each week focusing on different activities to improve temporal adaptation skills. Activities include teaching concepts of calendars and clocks, rhythm exercises with metronomes, time estimation games, daily and weekly planner preparation, time matching games, and exercises to improve time management and planning abilities.

Data will be collected using various tools including a demographic information form, time perception threshold measurement tasks, temporal production tasks, Child Activity Self-Assessment Scale (COSA), and Executive Functions and Occupational Routines Scale (EFORTS). The study's hypotheses test the null hypothesis that temporal adaptation intervention does not affect activity self-efficacy, time perception, daily activity routine, and executive functions in children aged 9-12 with ADHD.

This comprehensive approach aims to enhance the daily lives of children with ADHD by improving their ability to manage time effectively, thereby positively affecting their education, self-care, social relationships, and overall quality of life.

详细描述

This study explores the efficacy of a temporal adaptation intervention in enhancing the quality of life and functional abilities of children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a neurodevelopmental disorder characterized by patterns of inattention, impulsivity, and hyperactivity that detrimentally influence an individual's academic, social, motor, sensory, and executive functioning. Notably, children with ADHD often struggle with time processing abilities, which can manifest as difficulties in understanding time concepts, adhering to schedules, and managing daily activities.

Background ADHD significantly impacts the cognitive and behavioural domains of affected children, leading to challenges in daily living and academic achievement. Previous research has identified specific issues in time perception and temporal processing among children with ADHD, including time duration discrimination and time reproduction. These difficulties extend to both the understanding and management of time, impacting their daily routines and task completion. Functional and structural imaging studies have shown that the brain regions involved in time processing overlap with areas implicated in the pathogenesis of ADHD, such as the neocerebellum, basal ganglia, and prefrontal cortex. Given the centrality of time management skills to academic performance, self-care, and social interactions, interventions aimed at improving these skills could significantly enhance the functional outcomes for children with ADHD.

Objective The primary objective of this research is to evaluate the effectiveness of a temporal adaptation intervention aimed at improving activity self-efficacy, time perception, daily activity routines, and executive functions among children with ADHD. The intervention seeks to address the specific temporal processing challenges faced by these children, potentially leading to better time management, planning, and organizational skills.

Methods The intervention will be structured around a series of activities and individual sessions designed based on models of temporal adaptation training adapted for ADHD. These activities will target the development of skills related to the understanding and management of time, such as using calendars and clocks, estimating the duration of activities, and planning and executing daily and long-term tasks.

Setting and Participants The research will be carried out at a university's health sciences faculty, utilizing its educational and research facilities. The study will include children who meet the inclusion criteria of being diagnosed with ADHD, within the age range of 9-12 years, and voluntarily agree to participate. Exclusion criteria include the presence of additional diagnoses and the unwillingness of parents to adhere to the intervention protocols.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
9 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Must be between 9 and 12 years of age.
  • •Clinical diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  • •Must be willing to participate and adhere to the study protocols

排除标准

  • •* Additional psychiatric or developmental diagnoses that can interfere with the study outcomes

研究组 & 干预措施

Control Group

Active Comparator

The participants who are allocated to the Control Group arm will receive conventional occupational therapy interventions for the duration of the study.

干预措施: Conventional Occupational Therapy (Behavioral)

Experimental Group

Experimental

Participants allocated to the Experimental Group will receive Temporal Adaptation Intervention during the study.

干预措施: Temporal Adaptation Intervention (Behavioral)

结局指标

主要结局

Time Perception Threshold Measurement

时间窗: From enrollment to the end of treatment at 10 weeks

Assesses the ability to discriminate between different durations.

Temporal Production Task

时间窗: From enrollment to the end of treatment at 10 weeks

Evaluates the accuracy of reproducing time intervals.

Child Occupational Self-Assessment Scale

时间窗: From enrollment to the end of treatment at 10 weeks

The Child Occupational Self-Assessment Scale measures perceived efficacy and importance in daily activities. The scale consists of 25 items that evaluate the children's perceived occupational performance and the importance of the occupations under seven areas. All questions are scored from 1 to 4. The scale yields 14 different sub-scores (a performance and an importance score for each area). The Communication and the Executive Functions sub-scores range between 6 and 24, the Motor Skills sub-scores range between 3 and 12, the Academic sub-scores range between 5 and 20 and the Self Regulation, Intrumental Activities of Daily Living and Activities of Daily Living sub-scores range between 2 and 8. For the performance sub-scores, a higher score indicate better perceived performance. For the importance sub-scores, a higher score indicate higher given importance.

Executive Functions and Occupational Routines Scale

时间窗: From enrollment to the end of treatment at 10 weeks

The scale ssesses executive functioning and daily routines. The scale consists of 30 items, divided into subscales based on everyday functional routines, scored from 1 (never) to 5 (always). The scale does not have a total score, rather, a mean score is calculated for each sub-scale as well as the total scale. The mean score ranges between 1 and 5, with with higher scores indicating better executive control.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gonca Bumin

Supervisor

Hacettepe University

研究点 (1)

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