NCT04231604

Brief Summary

The aim of this pilot study is to evaluate a universal school-based multi-component intervention whose target is to build well-being and emotional resilience in adolescents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
604

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

January 17, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

January 7, 2020

Last Update Submit

September 27, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Well-being measured by the Adolescent Mental Health Continuum-Short Form

    Scores on the Adolescent Mental Health Continuum-Short Form range from 14 to 84. Higher scores indicate lower well-being.

    6 weeks after beginning intervention: 19/10/2020

  • Well-being measured by the Adolescent Mental Health Continuum-Short Form

    Scores on the Adolescent Mental Health Continuum-Short Form range from 14 to 84. Higher scores indicate lower well-being.

    12 weeks after beginning intervention: 01/12/2020

Secondary Outcomes (2)

  • Resilience measured by the Connor-Davidson Resilience Scale-10

    6 weeks after beginning intervention: 19/10/2020

  • Resilience measured by the Connor-Davidson Resilience Scale-10

    12 weeks after beginning intervention: 01/12/2020

Other Outcomes (5)

  • Emotional literacy measured by the Emotional Literacy and Intervention Inventory-Pupil Checklist

    6 weeks after beginning intervention: 19/10/2020

  • Emotional literacy measured by the Emotional Literacy and Intervention Inventory-Pupil Checklist

    12 weeks after beginning intervention: 01/12/2020

  • Mindfulness measured by the Mindful Attention Awareness Scale for Children

    6 weeks after beginning intervention: 19/10/2020

  • +2 more other outcomes

Study Arms (2)

A Lust for Life programme group

EXPERIMENTAL

A Lust for Life programme will be delivered to adolescents by their school teachers in six weekly lessons. Well-being and resilience will be promoted in each lesson through classroom discussions, videos, classroom activities and homework assignments.

Behavioral: A Lust for Life

Waiting list control group

OTHER

Participants will be placed on a twelve-week waiting list for the programme.

Behavioral: Waiting list control

Interventions

A Lust for LifeBEHAVIORAL

A Lust for Life is a universal school-based multi-component programme whose target is to build well-being and emotional resilience in adolescents. The programme was informed by evidence-based psychological approaches including mindfulness, cognitive behaviour therapy and positive psychology. It is delivered in six weekly lessons by the adolescents' school teacher and involves classroom discussions, videos, classroom activities and homework assignments.

A Lust for Life programme group

Control group placed on a twelve-week waiting list.

Waiting list control group

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescent
  • Enrolled 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, Ireland

Location

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

January 7, 2020

First Posted

January 18, 2020

Study Start

January 17, 2020

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

September 28, 2021

Record last verified: 2021-09

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, resilience, emotional literacy and mindfulness.

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, resilience, emotional literacy and mindfulness.

Locations