Effectiveness of a School Wellbeing Programme for Internalising Problems in Irish Primary School Children
Primary Purpose
Anxiety, Low Mood
Status
Active
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
A Lust for Life Schools Programme
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
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
Sites / Locations
- University College Dublin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A Lust for Life Schools Programme Group
Waiting list control group
Arm Description
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.
Participants will be placed on a sixteen-week waiting list for the programme.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Coping skills as measured by the Coping Strategy Indicator
33-item measure that measures three coping factors: seeking social support, problem-solving, and avoidance.
Self-efficacy as measured by the Self-Efficacy Questionnaire for Children
24-item questionnaire that measures three factors: academic, social and emotional self-efficacy.
Full Information
NCT ID
NCT05061381
First Posted
September 7, 2021
Last Updated
November 3, 2022
Sponsor
University College Dublin
1. Study Identification
Unique Protocol Identification Number
NCT05061381
Brief Title
Effectiveness of a School Wellbeing Programme for Internalising Problems in Irish Primary School Children
Official Title
Evaluating the Impact of a School Wellbeing Programme on Internalising Problems in Primary School Children
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 11, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College Dublin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Low Mood
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A Lust for Life Schools Programme Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting list control group
Arm Type
No Intervention
Arm Description
Participants will be placed on a sixteen-week waiting list for the programme.
Intervention Type
Behavioral
Intervention Name(s)
A Lust for Life Schools Programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Symptoms of anxiety and low mood measured by the Revised Children's Anxiety and Depression Scale Short Form
Description
25-item self-report measure of anxiety and depression symptoms of individuals aged 8-18 years.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Coping skills as measured by the Coping Strategy Indicator
Description
33-item measure that measures three coping factors: seeking social support, problem-solving, and avoidance.
Time Frame
16 weeks
Title
Self-efficacy as measured by the Self-Efficacy Questionnaire for Children
Description
24-item questionnaire that measures three factors: academic, social and emotional self-efficacy.
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Satisfaction with the programme measured by the Brief Satisfaction Scale
Description
Scores on each item of the Brief Satisfaction Scale range from 1 to 7
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aoife Clancy
Organizational Affiliation
University College Dublin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College Dublin
City
Dublin
State/Province
Tipperary
ZIP/Postal Code
E41 AT10
Country
Ireland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Effectiveness of a School Wellbeing Programme for Internalising Problems in Irish Primary School Children
We'll reach out to this number within 24 hrs