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Clinical Trials/NCT06135779
NCT06135779
Recruiting
N/A

Evaluation of the Effectiveness of a Universal School-based Intervention to Improve the Well-being of Children Aged 8-11 Years.

University College Dublin1 site in 1 country300 target enrollmentAugust 31, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Well-Being, Psychological
Sponsor
University College Dublin
Enrollment
300
Locations
1
Primary Endpoint
Wellbeing measured by the Feeling Better Scale
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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 8 to 11 years, who are attending 3rd class or 4th class in primary level education in Ireland.

Detailed Description

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 8-11 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.

Registry
clinicaltrials.gov
Start Date
August 31, 2023
End Date
June 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Children aged 8-11 years
  • Enrolled in 3rd and 4th classes in Primary School in Ireland
  • Obtain written informed consent from parents/guardians
  • Provide written assent

Exclusion Criteria

  • Failure to meet inclusion criteria

Outcomes

Primary Outcomes

Wellbeing measured by the Feeling Better Scale

Time Frame: 10 weeks after beginning the intervention

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

Secondary Outcomes

  • Wellbeing measured by the Stirling Children's Wellbeing Scale(10 weeks after beginning the intervention)
  • 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)

Study Sites (1)

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