- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05061381
Effectiveness of a School Wellbeing Programme for Internalising Problems in Irish Primary School Children
Evaluating the Impact of a School Wellbeing Programme on Internalising Problems in Primary School Children
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tipperary
-
Dublin, Tipperary, Ireland, E41 AT10
- University College Dublin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Aoife Clancy, University College Dublin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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