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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Child, Only; Well-Being, Psychological
• Intervention / Treatment: Behavioral: A Lust for Life; Behavioral: Waiting List Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alan Carr, Professor; Phone Number: 0035317168740; Email: alan.carr@ucd.ie

Study Locations

• Ireland
  • Leinster
    • Dublin, Leinster, Ireland, Dublin 4
      • Recruiting
      • University College Dublin
      • Contact: Alan Carr, Professor; Phone Number: 0035317168740; Email: alan.carr@ucd.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Waiting list control group; 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; Control group placed on a 12-week waiting list for the A Lust for Life School programme.
Experimental: A Lust for Life programme group; A Lust for Life programme will be delivered to participants by their class teachers in ten weekly sessions	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University College Dublin
• Investigators: Principal Investigator: Alan Carr, Professor, University College Dublin

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HS-22-80-Carr

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified data collected in this research will be archived. Other researchers may contact the investigators to access the de-identified data for use in research into well-being.
• IPD Sharing Time Frame: The data collected in this study will be made available for other researchers after a manuscript reporting on the study's findings has been accepted for publication.
• IPD Sharing Access Criteria: Data may be accessed for use in research into well-being.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No