Viewing Study NCT06135766



Ignite Creation Date: 2024-05-06 @ 7:47 PM
Last Modification Date: 2024-10-26 @ 3:14 PM
Study NCT ID: NCT06135766
Status: RECRUITING
Last Update Posted: 2024-01-18
First Post: 2023-11-13

Brief Title: Evaluating the Effectiveness of a School-based Intervention to Improve the Wellbeing of Children Aged 10 to 13 Years
Sponsor: University College Dublin
Organization: University College Dublin

Study Overview

Official Title: Evaluation of the Effectiveness of a Universal School-based Intervention to Improve the Wellbeing of Children Aged 10 to 13 Years
Status: RECRUITING
Status Verified Date: 2024-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 10 to 13 years who are attending 5th class or 6th 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 10 and 13 years All study participants will complete the Feeling Better Scale Stirling Childrens Wellbeing Scale and Revised Childrens 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None