Clinical trial NCT06135766: Evaluating the Effectiveness of a School-based Intervention to Improve the Wellbeing of Children Aged 10 to 13 Years.
Official title: Evaluation of the Effectiveness of a Universal School-based Intervention to Improve the Wellbeing of Children Aged 10 to 13 Years.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Well-Being, Psychological
Child, Only
Lead sponsor: University College Dublin
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 300
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Failure to meet inclusion criteria

Primary outcomes:
measure: Wellbeing measured by the Feeling Better Scale
timeFrame: 10 weeks after beginning the intervention
Secondary outcomes:
measure: Wellbeing measured by the Stirling Children's Wellbeing Scale
timeFrame: 10 weeks after beginning the intervention
measure: Anxiety and low mood measured by the Revised Children's Anxiety and Depression Scale
timeFrame: 10 weeks after beginning the intervention
measure: Programme satisfaction with the Satisfaction Scale
timeFrame: 10 weeks after beginning the intervention
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University College Dublin
state: Leinster
Study officials:
affiliation: University College Dublin
name: Alan Carr, Professor
role: PRINCIPAL_INVESTIGATOR
References: