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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Well-Being, Psychological, Child, Only

Intervention / Treatment
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* Behavioral: A Lust for Life
* Behavioral: Waiting List Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A Lust for Life programme group<br>A Lust for Life programme will be delivered to participants by their class teachers in ten weekly sessions | Behavioral: A Lust for Life<br>* 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.<br>|
| Other: Waiting list control group<br>Participants will receive curriculum as usual from their class teacher, and placed on a 12-week waiting list for the programme. | Behavioral: Waiting List Control<br>* Control group placed on a 12-week waiting list for the A Lust for Life School programme.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wellbeing measured by the Feeling Better Scale | Scores on the Feeling Better Scale range from 0 to 152. Higher scores indicate higher levels of wellbeing. | 10 weeks after beginning the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wellbeing measured by the Stirling Children's Wellbeing Scale | Scores on the Stirling Children's Wellbeing Scale range from 12 to 60. Higher scores indicate higher wellbeing. | 10 weeks after beginning the intervention | 
| Anxiety and low mood measured by the Revised Children's Anxiety and Depression Scale | Scores on the Revised Children's Anxiety and Depression Scale range from 0 to 75. Higher scores indicate greater severity of anxiety and low mood. | 10 weeks after beginning the intervention | 
| Programme Satisfaction with the Satisfaction Scale | Scores on the Satisfaction Scale range from 8 to 56. Higher scores indicate higher satisfaction | 10 weeks after beginning the intervention |