The Effects of Cognitive Behavioral Play Intervention on the Quality of Life of Children With Childhood-onset Epileptic Syndromes."
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- effect of cognitive behavioral play intervention on quality of life
研究概览
简要总结
The goal of this clinical trial is to assess the effectiveness of Cognitive Behavioral Play Therapy interventions in patients with epilepsy.
Children with epilepsy will be randomly assigned to one of two intervention conditions: the experimental group will receive cognitive-behavioral play intervention, while the control group will engage in free play. Assessments will be done at the start (T0) and end (T1) of the intervention, measuring behaviors, coping strategies, positive thinking, problem-solving, and quality of life.
详细描述
Cognitive-Behavioral Play Therapy (CBPT) adapts Cognitive-Behavioral Therapy techniques into a play-based intervention for preschool and school-age children, especially for those facing challenges like hospitalization or chronic illnesses. Studies show that play has therapeutic value, helping children understand critical events, reduce anxiety, and cope with illness. This research aims to explore how CBPT can be applied in hospitals, specifically for children with epilepsy, to improve their quality of life, enhance problem-solving, and foster positive coping strategies. The goal is to validate CBPT as a supportive tool for enhancing psycho-emotional development and complementing medical care in hospital settings.
The study proposes a randomized controlled trial with two groups: children with epilepsy will be randomly assigned to either the cognitive-behavioral play intervention or free play. The study will assess internalizing and externalizing behaviors, coping strategies, positive thinking, problem-solving skills, and quality of life at baseline (T0) and after the 8 intervention sessions (T1).
The goal is to determine whether cognitive-behavioral play improves quality of life more than free play.
Both groups will participate in 8 weekly 40-minute play sessions, with an initial and final meeting to administer the questionnaires.
The psychologist conducting the assessments will be unaware of group assignments.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The person responsible for enrollment and the one responsible for pre- and post-intervention evaluations of participants will be blinded (single-blind) to the assignment to intervention conditions. Unblinding of the intervention condition may occur in the case of adverse clinical conditions that may arise during the study or due to the participants' early withdrawal from the study at their personal request.
The person responsible for randomization and statistical analyses, as well as those who will administer the treatments, will be aware of the participants' assignment condition.
入排标准
- 年龄范围
- 6 Years 至 10 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the purposes of the study, children aged between 6 and 10 years, of both sexes, will be recruited.
- •inclusion criteria Children diagnosed with the following types of epilepsy will be included: childhood self-limiting focal epilepsy (SeLFE); childhood absence epilepsy (CAE); self-limiting centrotemporal paroxysmal epilepsy (SeLECTS); self-limiting epilepsy with autonomic seizures (SeLEAS); childhood occipital epilepsy (COVE); photosensitive occipital lobe epilepsy (POLE).
排除标准
- •Children with epilepsy in comorbidity with cognitive disabilities (the relevant cognitive disabilities must be specified with IQ scores)
- •reduced visual or expressive hearing acuity (visually impaired or deaf) will be excluded.
研究组 & 干预措施
Experimental condition cognitive behavioral play intervention CBPI
In the CBPI condition, children are given dolls and miniature props to play with, aiming to promote positive thinking. Each session includes stories on health, emotional well-being, social activities, and school life. The researcher teaches problem-solving by modeling steps like identifying the problem, generating solutions, evaluating them, and choosing the best solution. In each session, the researcher models the process four times and makes positive affirmations.
The CBPI intervention and the free play control condition are similar, with both groups engaging in pretend play. The researcher uses standardized prompts and spends equal time and attention with each child. The key difference is that in the CBPI intervention, the researcher uses dolls to model positive thinking and problem-solving, while encouraging children's imagination and emotional expression. Techniques from play therapy are used to help children integrate their feelings into the stories
干预措施: cognitive behavioral play intervention (Behavioral)
control condition of free playFP
The free play (FP) control condition allows the researcher to assess the effects of pretend play and provide positive attention to children. Children in this condition receive the same dolls and props, and hear the same stories as those in the cognitive-behavioral play intervention. After each story, they are encouraged to create their own story, but are free to play as they wish, often engaging in play unrelated to the story prompt. The researcher follows the child's lead, offering positive attention and non-specific praise but does not guide the play. The main difference between the two conditions is that in the FP condition, the researcher provides attention without directing the play, while in the intervention condition, the researcher actively guides the child's play to model problem-solving and positive thinking.
结局指标
主要结局
effect of cognitive behavioral play intervention on quality of life
时间窗: 2 months
To assess whether there is an improvement in the quality of life in children with epilepsy following a cognitive-behavioral play intervention , and whether these improvements are greater in this group compared to the control group. The Pediatric Quality of Life Inventory (PedsQL) Epilepsy Module will be used to measure the variable targeted by the intervention. The questionnaire uses a 5-point scale ranging from 0 (Never a problem) to 4 (Almost always a problem) for child and parent-report forms. For overall scores, it's possible to calculate a summary score with a range from 0 (worst possible health-related quality of life) to 100 (best possible health-related quality of life). Higher scores on the PedsQL Epilepsy Module indicate a better outcome, reflecting better health-related quality of life. Lower scores suggest a worse outcome.
次要结局
- effect of cognitive behavioral play intervention on coping strategies(2 months)
- effect of cognitive behavioral play intervention on positive thinking(2 months)
