Effectiveness of a School Wellbeing Programme for Internalising Problems in Irish Primary School Children

November 3, 2022 updated by: University College Dublin

Evaluating the Impact of a School Wellbeing Programme on Internalising Problems in Primary School Children

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Childhood and adolescence are important developmental phases for wellbeing and mental health. School has been noted in psychological literature to be a favourable environment for mental health initiatives, such as school-based programmes. Universal programmes are programmes delivered to all pupils irrespective of perceived need and have several advantages, including having a wide reach, avoiding the need for screening and are less stigmatising.

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

Study participants will complete the Revised Children's Anxiety and Depression Scale Short Format, Coping strategy indicator and Self-Efficacy Questionnaire for Children pre-intervention. Following this, schools randomly assigned to the experimental group will receive A Lust for Life, while those randomly assigned to the control group will be placed on a sixteen-week waiting list. The questionnaire measures and a Brief Satisfaction Scale will be completed by participants at post-intervention. In addition, a six-week follow-up assessment will determine whether the effects of the programme are sustained over a period of time. The programme will be delivered in the waiting list control group schools after the six-week follow-up assessment.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tipperary
      • Dublin, Tipperary, Ireland, E41 AT10
        • University College Dublin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Child
  • Enrolled in primary school in Ireland
  • Obtain written informed consent from parents/guardians
  • Provide written assent

Exclusion Criteria:

  • Failure to meet inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A Lust for Life Schools Programme Group
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.
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.
No Intervention: Waiting list control group
Participants will be placed on a sixteen-week waiting list for the programme.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms of anxiety and low mood measured by the Revised Children's Anxiety and Depression Scale Short Form
Time Frame: 16 weeks
25-item self-report measure of anxiety and depression symptoms of individuals aged 8-18 years.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coping skills as measured by the Coping Strategy Indicator
Time Frame: 16 weeks
33-item measure that measures three coping factors: seeking social support, problem-solving, and avoidance.
16 weeks
Self-efficacy as measured by the Self-Efficacy Questionnaire for Children
Time Frame: 16 weeks
24-item questionnaire that measures three factors: academic, social and emotional self-efficacy.
16 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with the programme measured by the Brief Satisfaction Scale
Time Frame: 10 weeks
Scores on each item of the Brief Satisfaction Scale range from 1 to 7
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Aoife Clancy, University College Dublin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2021

Primary Completion (Actual)

July 1, 2022

Study Completion (Anticipated)

November 30, 2022

Study Registration Dates

First Submitted

September 7, 2021

First Submitted That Met QC Criteria

September 20, 2021

First Posted (Actual)

September 29, 2021

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • aclancy

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 anxiety, depression, coping skills and self-efficacy.

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 anxiety, depression, coping skills and self-efficacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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