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临床试验/NCT05869253
NCT05869253已完成不适用

The Efficacy of Attention Skill Therapy (ASTride), an Equine Assisted Occupational Therapy Intervention, for Children With Attention Deficit Hyperactivity Disorder (ADHD) on Cognitive-emotional Aspects, Daily Function and Participation

Tel Aviv University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
The Behavior Rating Inventory of Executive Function (BRIEF) (Gioia, Isquith, Guy, & Kenworthy, 2000)

研究概览

简要总结

The goal of this clinical trial is to develop and validate an Equine Assisted Occupational Therapy Intervention for children aged 6-12 with Attention Deficit Hyperactivity Disorder.

The research aims to study the effect of an EAOT intervention on cognitive-emotional aspects, daily function and participation among these children using various measurements including physiological measures (EEG, heart rate for rider and horse), questionnaires and different tasks. It aims to enable the creation of an evidence based protocol for professionals in order to provide a better suited therapy for children with ADHD and enable them to live a full life. Participants will enroll in a 12 week EAOT intervention including one session per week of 45 minutes with a waiting period prior the intervention. Participants will go through assessments prior waiting time, prior the intervention and post intervention.

详细描述

Introduction

Attention deficit/hyperactivity disorder (ADHD), characterized by inattention, hyperactivity and impulsivity, is currently one of the most common diagnoses given to children. ADHD is characterized by a developmental and chronic impairment, Executive Functions (EFs), cognitive-emotional and sensory-motor functions, as well as a wide variety of difficulties in daily tasks beyond the core symptoms. Literature review indicated that current intervention protocols include pharmacological treatment and address specific aspects such as behavioral or psychological, though scarce interventions address both.

Objectives: The purpose of this study is to examine the feasibility of conducting an Equine Assisted Occupational Therapy (EAOT) intervention for children with ADHD aiming to improve EFs, cognitive-emotional functions and participation.

Method: A prospective cohort study with Interrupted Time-Series design will be conducted. Forty participants and their parents who were referred to EAOT will be recruited from the waiting list of Harey Yehuda stables. Assessments will take place at four time points. Time 1: baseline-when referred for EAOT. Time 2: pre-test, before first treatment session, end of 12 week waiting period. Time 3: post-test after 12 weeks of intervention and time 4: post intervention assessment, three months follow up. The intervention will be administered by a licensed EAOT, and assessments will be done by a blinded licensed occupational therapist (OT). Standardized assessment measures will be used to measure EFs, cognitive-emotional and sensory-motor aspects as well as participation at each time point.

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

盲法说明

The intervention will be administered by a licensed EAOT, and assessments will be done by a blinded licensed occupational therapist (OT).

入排标准

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

入选标准

  • Children between 6 and 12 years of age
  • Diagnosis of ADHD from a medical professional based on DSM-5 criteria with or without medication (e.g., psychostimulant medication)
  • General doctors' approval and referral for participating in EAS

排除标准

  • Moderate to severe cognitive impairment
  • Neurological disorders (e.g., epilepsy)
  • Children with additional developmental disorders (e.g., Autism, Cerebral Palsy)
  • Children who will begin new medicine treatment or change existing treatment during intervention
  • Children with severe sensory loss (e.g., blindness).

结局指标

主要结局

The Behavior Rating Inventory of Executive Function (BRIEF) (Gioia, Isquith, Guy, & Kenworthy, 2000)

时间窗: 3 months

standardized ecological rating scale filled by a parent, designed to reflect the neuropsychological constructs of EF in everyday situations for children aged 5-18

次要结局

  • The Screen for Child Anxiety Related Emotional Disorders (SCARED)(3 months)
  • Canadian Occupational Performance Measure (COPM) (Law et al., 2014)(3 months)
  • The children Participation Questionnaire (CPQ)(3 months)
  • The new General Self-efficacy Scale (NGSE)(3 months)
  • The Brain Engagement Index; BEI (Shahaf et al., 2018)(3 months)
  • The Hebrew adaptation of The Children's Hope Scale (Snyder, 2002)(3 months)
  • The Short Sensory Profile (SSP)(3 months)
  • the Tower of Hanoi test (Lezak et al., 2004).(3 months)
  • The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)(3 months)
  • The Child Performance Skill Questionnaire (PSQ)(3 months)

研究者

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

Orit Bart PhD

Lead investigator

Tel Aviv University

研究点 (2)

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