NCT06135779

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

10 months

First QC Date

November 13, 2023

Last Update Submit

January 15, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Wellbeing measured by the Stirling Children's Wellbeing Scale

    10 weeks after beginning the intervention

  • Anxiety and low mood measured by the Revised Children's Anxiety and Depression Scale

    10 weeks after beginning the intervention

  • Programme Satisfaction with the Satisfaction Scale

    10 weeks after beginning the intervention

Study Arms (2)

A Lust for Life programme group

EXPERIMENTAL

A Lust for Life programme will be delivered to participants by their class teachers in ten weekly sessions

Behavioral: A Lust for Life

Waiting list control group

OTHER

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

Interventions

A Lust for LifeBEHAVIORAL

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.

A Lust for Life programme group

Control group placed on a 12-week waiting list for the A Lust for Life School programme.

Waiting list control group

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Dublin

Dublin, Leinster, Dublin 4, Ireland

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Alan Carr, Professor

    University College Dublin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alan Carr, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2023

First Posted

November 18, 2023

Study Start

August 31, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

January 18, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
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.
Access Criteria
Data may be accessed for use in research into well-being.

Locations