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临床试验/NCT02349529
NCT02349529Unknown不适用

An Exploratory Randomised Controlled Trial of a Manualised Psychosocial Group Intervention for Young People With Epilepsy (PIE)

NHS Greater Glasgow and Clyde0 个研究点目标入组 200 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
主要终点
Effectiveness of the PIE group

研究概览

简要总结

Children and young people with epilepsy are at increased risk of poorer outcomes related to emotional and psychological adjustment, peer relationship problems, lower academic attainment and mental health problems across the lifespan. Despite the well understood risks, there continues to be a lack of psychological and psychosocial support for young people with epilepsy, and a corresponding lack of evidence regarding the effectiveness of psychosocial interventions. This study aims to evaluate a manualised psychosocial group intervention for adolescents with epilepsy. A cognitive behaviour therapy approach is used, aimed at increasing awareness of how epilepsy may impact upon thoughts, feelings and activities and to develop strategies for improved psychological adjustment. In addition, an epilepsy knowledge component aimed at improving a sense of control and epilepsy self-management is included. A group delivery format allows an opportunity for social modelling, and social problem solving, helping others and relating to other young people with similar experiences. The social learning context and availability of knowledgable facilitators (an epilepsy nurse specialist and clinical psychologist) are also key aspects of the intervention. The study will allow us to establish a standard manualised group intervention that can be used throughout the UK which aims to; establish the effectiveness and desirability of this approach; improve the overall quality of life, psychological health and social integration of young people with epilepsy; and to improve epilepsy knowledge and selfmanagement skills aimed at maximising seizure control and overall management.

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
None

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Written informed consent
  • Diagnosis of epilepsy (controlled or refractory) of at least 6 months duration
  • Between the ages of 1217 years old
  • Have a reasonable level of expressive and receptive English language abilities to enable them to fully participate and contribute to the group process
  • In mainstream schooling.

排除标准

  • Formal diagnosis of Learning Disability or attendance at a school for children with Special Educational Needs
  • Complex and severe mental health problems;
  • Diagnosis of nonepileptic seizures in the absence of epileptic seizures
  • Epilepsies occurring in the context of:
  • Postnatally acquired structural lesions (e.g. TBI or neurooncological conditions)
  • Immune mediated disorders (e.g. limbic or antiNMDAR encephalopathy)
  • Metabolic disorders (e.g. GLUT1 deficiency)

结局指标

主要结局

Effectiveness of the PIE group

时间窗: 6 months

次要结局

  • The Paediatric Index of Emotional Distress (PIED).(Baseline, 6 weeks, 3 months and 6 months)
  • The Seizure Self Efficacy Scale for Children (SSEC)(Baseline, 6 weeks, 3 months and 6 months)
  • Epilepsy Knowledge ProfileGeneral (EKPG)(Baseline, 6 weeks, 3 months and 6 months)
  • Brief Illness Representations Questionnaire (BIPQ).(Baseline, 6 weeks, 3 months and 6 months)
  • Participant social functioning(Baseline, 6 weeks, 3 months and 6 months)
  • seizure control(Baseline, 6 weeks, 3 months and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

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