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临床试验/NCT06884007
NCT06884007已完成不适用

Dikkat Eksikliği Ve Hiperaktivite Bozukluğu Olan Çocukların Primer Bakım Verenlerinde Telepsikiyatrik Ebeveyn Eğitimi Programının Etkilerinin İncelenmesi

Uşak University2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2021年9月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
2
主要终点
Zarit Burden Interview (ZBI-22)

研究概览

简要总结

This study was conducted to examine the effects of a telepsychiatric parent training program implemented for primary caregivers of children with Attention Deficit Hyperactivity Disorder (ADHD).

The study employed a quasi-experimental pre-test, post-test, and re-test control group design. It was conducted from March to June 2022 via videoconferencing with primary caregivers of children aged 7-12 years diagnosed with ADHD, registered at the Child and Adolescent Mental Health Outpatient Clinic of Dokuz Eylül University Hospital. Caregivers in the experimental group completed Turkey's first "Telepsychiatric Parent Training" program, featuring nine 60-minute videoconference sessions. Data were collected using the "Descriptive Information Form," "Zarid Burden Interview (ZBI-22)," "Perceived Stress Scale (PSS-14)," and "Strengths and Difficulties Questionnaire (SDQ)." Data were collected before the program, after the program, and at the 2-month follow-up. The program was also implemented with caregivers in the control group after the research process was completed. Data from the experimental and control groups were analyzed using two-way mixed ANOVA. To determine the effect of the intervention, post-hoc power (β) analysis was conducted using the G*Power 3.1.9.7 program, and the level of statistical significance was set at 0.05. Study hypotheses are:

H1: There is a difference in the average scores of the Caregiving Burden Scale (CBS) for primary caregivers of children with ADHD based on time, group, and the group*time interaction after the application of a parent training program.

H2: There is a difference in the average scores of the Perceived Stress Scale (PSS-14) for primary caregivers of children with ADHD based on time, group, and the group*time interaction after the application of a parent training program.

H3: There is a difference in the average scores of the Strengths and Difficulties Questionnaire (SDQ) for primary caregivers of children with ADHD based on time, group, and the group*time interaction after the application of a parent training program.

All caregivers (100%) successfully completed the program. Caregivers showed significant improvements in caregiving burden, stress levels , and difficulties.

详细描述

This study explores the effects of a telepsychiatric parent training program designed for primary caregivers of children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a common neurodevelopmental disorder that significantly impacts children's behavior, attention, and social interactions, leading to challenges for both the children and their caregivers. This study aimed to assess how a structured, remote training program could help caregivers manage these challenges by reducing caregiver burden, stress, and emotional difficulties.

The research employed a quasi-experimental design, involving both experimental and control groups to evaluate the program's effectiveness. The study was conducted from March to June 2022 with caregivers of children aged 7 to 12 years diagnosed with ADHD. Participants were recruited from the Child and Adolescent Mental Health Outpatient Clinic of Dokuz Eylül University Hospital.

Caregivers in the experimental group participated in Turkey's first "Telepsychiatric Parent Training" program, which consisted of nine 60-minute videoconference sessions. The program was delivered remotely, offering flexibility and ease of access for the participants. The training program was specifically designed to provide caregivers with practical tools and strategies for managing the behavioral challenges of children with ADHD. The sessions covered topics such as ADHD symptoms, parenting techniques, emotional regulation, and stress management.

To measure the effectiveness of the program, data were collected at three points: before the program, immediately after the program, and two months following the program. Several established scales were used to assess various aspects of the caregivers' experiences, including the Zarid Burden Interview (ZBI-22) to evaluate caregiving burden, the Perceived Stress Scale (PSS-14) to measure stress levels, and the Strengths and Difficulties Questionnaire (SDQ) to assess emotional and behavioral difficulties in the children. These tools provided a comprehensive view of the impact of the program on both the caregivers and the children.

The data analysis was conducted using two-way mixed ANOVA to assess the differences across time and between the experimental and control groups. The study's findings revealed significant improvements in caregiving burden, stress levels, and child difficulties, with statistical significance observed across pre-test, post-test, and follow-up measurements. These improvements were further supported by post-hoc power analysis, confirming the program's efficacy in addressing the challenges faced by caregivers of children with ADHD.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

In this study, participants were not informed about which group they were assigned to (experimental or control), as this could have influenced their perception and response to the interventions. Participants were randomly assigned to either the experimental or control group by a third-party who was not involved in the study itself. Both the participants and the investigators who interacted with them during the study sessions were blinded to group assignments. Additionally, the outcomes assessor, who evaluated the primary and secondary outcomes, was also blinded to group assignment to ensure objective measurement of the effects of the intervention. This approach aimed to minimize bias and ensure the validity of the results by preventing the influence of prior expectations or knowledge on both participant behavior and data assessment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Willingness to participate in the study.
  • Literacy skills (reading and writing ability).
  • A primary caregiver of a child diagnosed with ADHD (according to DSM V criteria), aged 7-12 years, currently on medication.
  • The primary caregiver must have been responsible for the child's care for at least 3 months.
  • The primary caregiver should be 18 years or older.

排除标准

  • The child has additional mental health conditions such as intellectual disability, psychotic disorders, post-traumatic stress disorder, bipolar disorder, obsessive-compulsive disorder, or pervasive developmental disorder.
  • The caregiver misses more than three sessions of the intervention.

结局指标

主要结局

Zarit Burden Interview (ZBI-22)

时间窗: Baseline (pre-test), immediately after the intervention (post-test, approximately Week 9), and follow-up at 2 months post-intervention (approximately Week 17).

This outcome measures the caregiver burden experienced by parents of children with ADHD. The ZBI-22 assesses various aspects of the emotional, physical, and social burden on caregivers. It evaluates the level of strain experienced by parents in relation to caregiving tasks and their well-being. The total burden score ranges from 0 to 88, with higher scores indicating a greater level of caregiver burden. Time Frame: The measurement will be taken at pre-test, post-test, and during a follow-up period after the intervention (i.e., 2 months post-intervention) to assess changes over time and group differences.

Perceived Stress (PSS-14)

时间窗: Baseline (pre-test), immediately after the intervention (post-test, approximately Week 9), and follow-up at 2 months post-intervention (approximately Week 17).

This outcome measures the perceived stress levels of caregivers using the PSS-14. The scale assesses the extent to which caregivers feel stress in their daily lives, particularly regarding the challenges of caring for children with ADHD. The total perceived stress score ranges from 0 to 56, with higher scores indicating greater perceived stress.

Emotional and Behavioral Issues in Children (SDQ)

时间窗: Baseline (pre-test), immediately after the intervention (post-test, approximately Week 9), and follow-up at 2 months post-intervention (approximately Week 17).

This outcome measures the emotional and behavioral issues in children with ADHD, as reported by their caregivers. The SDQ assesses various domains, including emotional symptoms, conduct problems, hyperactivity/inattention, peer relationships, and prosocial behavior. The total difficulties score ranges from 0 to 40, with higher scores indicating greater emotional and behavioral difficulties.

次要结局

  • Time-Related Changes in the Experimental Group(Baseline (Week 0), immediately after the intervention (Week 9), and follow-up at 2 months post-intervention (approximately Week 17).)

研究者

发起方
Uşak University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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