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临床试验/NCT06135766
NCT06135766招募中不适用

Evaluation of the Effectiveness of a Universal School-based Intervention to Improve the Wellbeing of Children Aged 10 to 13 Years.

University College Dublin2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年8月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
Wellbeing measured by the Feeling Better Scale

研究概览

简要总结

The aim of this study is to evaluate the effectiveness of a universal school-based intervention, which aims to improve the wellbeing of children aged 10 to 13 years, who are attending 5th class or 6th class in primary level education in Ireland.

详细描述

An estimated 10-20% of children and adolescents worldwide experience mental health difficulties, with 50% of difficulties emerging before the age of 14 years. School is an influential environment for young people, with school-based interventions consistently delivering positive mental health and wellbeing programmes in a cost-effective manner.

A Lust for Life (ALFL) is a universal teacher-led programme which aims to build resilience, increase wellbeing, and enhance emotional literacy of 8-13 year old school children. The programme spans ten 40-minute classes. The ALFL curriculum draws on multiple sources including contemporary positive psychology; traditional, second, and third wave cognitive behaviour therapy (CBT); and developmental, educational, and health psychology.

In ALFL children learn the following specific self-regulation skills: naming and rating the intensity of emotions; linking thoughts, feelings and actions; mindfulness; breathing exercises; visualization exercises; progressive muscle relaxation; positive self-talk (gratitude, optimism, and cognitive restructuring); obtaining social support from adults and peers; assertiveness; managing bullying; and using the internet safely. Skills are learned through didactic instruction, video modelling, in-class experiential exercises, and homework practice. The ongoing development of the ALFL programme follows best practice, with the most recently refined programme evaluated in this study.

This quasi-experimental randomized controlled trial study involves an experimental group and a waiting list control group of children aged between 10 and 13 years. All study participants will complete the Feeling Better Scale, Stirling Children's Wellbeing Scale, and Revised Children's Anxiety and Depression Scale at pre-intervention. Participants will complete the questionnaires online. Following this, schools randomly assigned to the experimental group will receive the ALFL programme, while those randomly assigned to the control group will be placed on a 12 week waiting list and receive curriculum as usual. At post-intervention, the questionnaire measures will be completed online by all study participants. The participants in the experimental group will also complete a brief Satisfaction Scale. The waiting list control group will then receive the A Lust for Life programme.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
10 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 10 to 13 years
  • Enrolled in primary school in Ireland
  • Obtain written informed consent from parents/guardians
  • Provide written assent

排除标准

  • Failure to meet inclusion criteria

结局指标

主要结局

Wellbeing measured by the Feeling Better Scale

时间窗: 10 weeks after beginning the intervention

Scores on the Feeling Better Scale range from 0 to 152. Higher scores indicate higher levels of wellbeing.

次要结局

  • Anxiety and low mood measured by the Revised Children's Anxiety and Depression Scale(10 weeks after beginning the intervention)
  • Programme satisfaction with the Satisfaction Scale(10 weeks after beginning the intervention)
  • Wellbeing measured by the Stirling Children's Wellbeing Scale(10 weeks after beginning the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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