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临床试验/NCT06624527
NCT06624527已完成不适用

The Effect of Cognitive Behavior Therapy-Based Psychoeducation Given to Children With Attention Deficit Hyperactivity Disorder on Children's Quality of Life, Anxiety and Depression

Hasan Kalyoncu University2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2023年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
试验地点
2
主要终点
Psycho-educational application based on Cognitive Behavioral Therapy

研究概览

简要总结

The aim of this study was planned to determine the changes that cognitive behavior therapy-based psycho-education against the negativities brought by the disease in the long term of children diagnosed with Attention Deficit Hyperactivity Disorder will create changes in the child's quality of life, anxiety and depression status and disease symptoms.

As a result of this study, if cognitive behavior-based psycho-education has a positive effect on anxiety, depression and quality of life of children with Attention Deficit Hyperactivity Disorder, it is thought to contribute positively to the development of the disease for the sick child and parents by organizing psycho-education programs with the training to be given to child health nurses.

详细描述

  1. Research Model This study was planned as a pre-test/post-test, single blind randomized controlled experimental design.
  2. Hypotheses of the Study Hypothesis 1 (H1): Does cognitive behavior therapy-based psycho-education given to children with ADHD affect children's quality of life? Hypothesis 2 (H2): Does cognitive behavior therapy-based psycho-education given to children with ADHD affect children's anxiety and depression levels?
  3. Place and Time of the Study This study was conducted at Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital / Department of Child and Adolescent Psychiatry between September 25, 2023 and December 30, 2024.
  4. Ethical Aspects of the Study
  • With the decision numbered 2022/29 of Hasan Kalyoncu University Health Sciences Institute Board of Directors, this research was accepted as a doctoral thesis subject on 19.12.2022.
  • Ethics committee permission was obtained from Hasan Kalyoncu University Faculty of Health Sciences Non-Interventional Research Ethics Committee with the decision numbered 2023/31 dated 31.01.2023.
  • Written institutional permission was obtained from Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital, where the research will be conducted, with decision number 24523 dated 22.09.2023.
  • Within the scope of the research, "CBT Practitioner Training in Children and Adolescents" was received from Fatih Sultan Mehmet University (Barcode No: UN_041054323475554869027).
  • The research was supported by the Scientific and Technical Research Council of Turkey 1002- A Rapid Support (Project No: 323S232).
  • For the scales used in the study, permission was obtained from the scale developers via e-mail.
  • Within the scope of the study, all participants who agreed to participate in the study were given preliminary information about the study.
  • Confidentiality of patients' names and information was taken as a basis.
  • No fee was requested from the patients to participate in the study and no additional payment was made to the patients participating in the study.
  • Participation in the study was voluntary.
  1. Population and Sample of the Study The population of the study consisted of all children with ADHD (newly diagnosed children and children who were followed up) and their parents who applied to the outpatient clinic.

The sample of the study consisted of patients who met the inclusion criteria and agreed to participate in the study. Before starting the study to determine the sample size, reference results were evaluated based on literature reviews. In line with the data entered into the G Power 3.1.9.7 program, alpha: 0.05, effect size 0.8, confidence interval 95%, the number of participants to be included in the study for each group was calculated as at least 35 children and 35 parents for the control and intervention groups separately, for a total of 70 control and 70 intervention groups. Considering the losses during the study, the study was started with groups of 40 participants each. 6. Sample Inclusion Criteria Criteria for children's participation in the study;

  • Diagnosed with ADHD according to DSM-V diagnostic criteria,
  • No other comorbid disease accompanying ADHD,
  • No mental disability,
  • Not receiving pharmacological treatment,
  • 8-16 years old,
  • Can read and write,
  • Communication and cooperation,
  • Children who agree to participate in the study (their parents and/or themselves) will be included in the study.

Criteria for parental participation in the study:

  • Allowing their child to participate in the study,
  • Living with her child,
  • the child's natural parent,
  • No hearing-speech impairment,
  • Without a diagnosed and treated mental illness,
  • Mothers who can communicate and are open to cooperation will be included in the study.
  1. Data Collection Tools In the collection of data, the "Personal Information Form" created in line with the literature, the "Revised Children's Anxiety and Depression Scale" filled out separately by the child and the parent to determine the anxiety and depression levels of children, and the "Quality of Life Scale for Children" to determine the quality of life of children were used.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

In this study, the sample group was determined in the masking process. The sample group was divided into a control group and an intervention group using a random sampling method. It was not disclosed which group the participants were in.

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children who are diagnosed with ADHD according to DSM-V diagnostic criteria,
  • Do not have another psychiatric disorder not specific to ADHD,
  • Do not have a mental disability,
  • Do not seek pharmacological treatment,
  • Are between the ages of 8-16,
  • Can read and write,
  • Can communicate and cooperate,
  • Agree to participate in the study (parents and/or themselves) are included in the study.

排除标准

  • Those with another psychiatric disorder not specific to ADHD,
  • Those with mental retardation,
  • Those receiving pharmacological treatment,
  • Those between the ages of 8-16,
  • Those who cannot read or write,
  • Those who request to withdraw from the study

结局指标

主要结局

Psycho-educational application based on Cognitive Behavioral Therapy

时间窗: 4 weeks

This study will investigate how cognitive behavior-based psychoeducation given to children diagnosed with Attention Deficit Hyperactivity Disorder will affect the child's quality of life, anxiety, and depression. Two scales will be used to measure the results of the interventions made in the research. These scales are: 1-Child Anxiety and Depression Scale; consists of 47 items. 2.Quality of life scale for children consists of 23 items.

次要结局

未报告次要终点

研究者

发起方
Hasan Kalyoncu University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vedat ARGIN

Lecturer

Hasan Kalyoncu University

研究点 (2)

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