NCT05061381

Brief Summary

The aim of this study is to assess the effectiveness of a school-based multi-component universal programme for the reduction of internalising problems (i.e. anxiety and low mood) in primary school pupils.

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
400

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Oct 2021

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

First Submitted

Initial submission to the registry

September 7, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

October 11, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

November 4, 2022

Status Verified

July 1, 2022

Enrollment Period

9 months

First QC Date

September 7, 2021

Last Update Submit

November 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Symptoms of anxiety and low mood measured by the Revised Children's Anxiety and Depression Scale Short Form

    25-item self-report measure of anxiety and depression symptoms of individuals aged 8-18 years.

    16 weeks

Secondary Outcomes (2)

  • Coping skills as measured by the Coping Strategy Indicator

    16 weeks

  • Self-efficacy as measured by the Self-Efficacy Questionnaire for Children

    16 weeks

Other Outcomes (1)

  • Satisfaction with the programme measured by the Brief Satisfaction Scale

    10 weeks

Study Arms (2)

A Lust for Life Schools Programme Group

EXPERIMENTAL

A Lust for Life programme will be delivered to primary school pupils 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 Schools Programme

Waiting list control group

NO INTERVENTION

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

Interventions

A Lust for Life is a universal school-based multi-component programme whose target is to build well-being and emotional resilience in children. 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 childrens' school teacher and involves classroom discussions, videos, classroom activities and homework assignments.

A Lust for Life Schools Programme Group

Eligibility Criteria

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

You may qualify if:

  • Child
  • 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, Tipperary, E41 AT10, Ireland

Location

MeSH Terms

Conditions

Anxiety DisordersConsciousness Disorders

Condition Hierarchy (Ancestors)

Mental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive Disorders

Study Officials

  • Aoife Clancy

    University College Dublin

    PRINCIPAL INVESTIGATOR

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

September 7, 2021

First Posted

September 29, 2021

Study Start

October 11, 2021

Primary Completion

July 1, 2022

Study Completion

November 30, 2022

Last Updated

November 4, 2022

Record last verified: 2022-07

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 anxiety, depression, coping skills and self-efficacy.

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 anxiety, depression, coping skills and self-efficacy.

Locations