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临床试验/CTRI/2026/02/103119
CTRI/2026/02/103119尚未招募不适用

Effectiveness of play based occupational therapy intervention on quality of life among children with attention deficit hyperactivity disorder

G Priyanka1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年2月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1

研究概览

简要总结

This study is a randomized ,Parallel group ,active controlled trial designed to evaluate the EFFECTIVENESS OF PLAY BASED OCCUPATIONAL THERAPY INTERVENTION ON QUALITY OF LIFE AMONG CHILDREN WITH ATTENTION DEFICIT HYPERACTIVE DISORDER .Prior to the initiation of the study, ethical approval will be obtained from the Institutional Review Board of Chettinad University Hospital CHRI, CARE. Before enrolling each child, written informed consent will be obtained from the parents or legal  guardians, and age appropriate assent will be obtained from the children. A total of 50 children aged 5 to 10 years diagnosed with ADHD will be recruited from the Occupational Therapy Department of Chettinad Hospital and Clinics, located in Chengalpattu District. Participants will be selected using a convenience sampling method. Initial screening will be conducted using the Vanderbilt ADHD Diagnostic Parent Rating Scale to confirm the diagnosis and eligibility according to the inclusion and exclusion criteria. After confirmation of eligibility and completion of consent procedures, the participants will be randomly allocated into two groups: an experimental group consisting of 25 children and a control group consisting of 25 children. Before the commencement of the intervention, a baseline (pre-intervention) assessment of quality of life will be conducted for all participants using the Pediatric Quality of Life Inventory. This assessment will provide information on the physical, emotional, social, and school functioning of the children. The experimental group will receive a structured play-based occupational therapy intervention, which includes figurine-based simulation activities combined with sensory integration techniques. These activities will be designed to enhance attention, self-regulation, participation, and functional performance in daily activities. The intervention will be administered for a duration of 4 weeks, with each session lasting 45 minutes, conducted three days per week.During this intervention period, the control group will continue with their routine care and will not receive any additional intervention from the researcher. At the end of the 4-week intervention period, a post-intervention assessment will be carried out for both groups using the same standardized tool, namely the Pediatric Quality of Life Inventory. The pre- and postintervention scores obtained from both the experimental and control groups will be statistically analyzed to determine the effectiveness of the play-based occupational therapy intervention in improving the quality of life of children with ADHD.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
5.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Children aged 5 to 10 years with a confirmed clinical diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) based on clinical evaluation and scores within the diagnostic range on the Vanderbilt ADHD Diagnostic Parent Rating Scale (VADPRS) will be included in the study.
  • Children who demonstrate difficulties in daily functioning and are currently receiving occupational therapy services, where required, will also be eligible for participation.
  • Only children with no reported history of other physical illnesses or medical conditions that could interfere with participation in the intervention will be considered for inclusion.

排除标准

  • Children with neurological disorders, developmental conditions, or psychiatric diagnoses other than ADHD will be excluded from the study.
  • Children younger than 5 years or older than 10 years will not be included.
  • Additionally, children whose VADPRS score fall below the diagnostic range for ADHD will be excluded to ensure homogeneity of the study sample .

研究者

发起方
G Priyanka
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

G PRIYANKA

Chettinad school of occupational therapy

研究点 (1)

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