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

Child, Only Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06135779
• Other study ID #: HS-22-80-Carr
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: University College Dublin
• Contact: Alan Carr, Professor
• Phone: 0035317168740
• Email: alan.carr[@]ucd.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Child, Only

Intervention

Behavioral:
• A Lust for Life
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.
• Waiting List Control
Control group placed on a 12-week waiting list for the A Lust for Life School programme.

Locations

Country	Name	City	State
Ireland	University College Dublin	Dublin	Leinster

Sponsors (1)

Lead Sponsor	Collaborator
University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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