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

Sponsor
University College Dublin (Other)
Overall Status
Recruiting
CT.gov ID
NCT06135779
Collaborator
(none)
300
1
2
10
30

Study Details

Study Description

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 8 to 11 years, who are attending 3rd class or 4th class in primary level education in Ireland.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: A Lust for Life
  • Behavioral: Waiting List Control
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Effectiveness of a Universal School-based Intervention to Improve the Well-being of Children Aged 8-11 Years.
Actual Study Start Date :
Aug 31, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. Wellbeing measured by the Feeling Better Scale [10 weeks after beginning the intervention]

    Scores on the Feeling Better Scale range from 0 to 152. Higher scores indicate higher levels of wellbeing.

Secondary Outcome Measures

  1. Wellbeing measured by the Stirling Children's Wellbeing Scale [10 weeks after beginning the intervention]

    Scores on the Stirling Children's Wellbeing Scale range from 12 to 60. Higher scores indicate higher wellbeing.

  2. Anxiety and low mood measured by the Revised Children's Anxiety and Depression Scale [10 weeks after beginning the intervention]

    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.

  3. Programme Satisfaction with the Satisfaction Scale [10 weeks after beginning the intervention]

    Scores on the Satisfaction Scale range from 8 to 56. Higher scores indicate higher satisfaction

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 11 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University College Dublin Dublin Leinster Ireland Dublin 4

Sponsors and Collaborators

  • University College Dublin

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University College Dublin
ClinicalTrials.gov Identifier:
NCT06135779
Other Study ID Numbers:
  • HS-22-80-Carr
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 18, 2023