- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04231604
Evaluation of a School-based Programme Aimed at Promoting Well-being in Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adolescence is an important developmental phase for prevention and intervention initiatives for well-being and mental health. Accordingly, school has been recommended as an optimal location for such initiatives. Universal programmes - programmes that are designated for all individuals in a population - have a number of advantages, including reducing the risk of stigma and yielding high recruitment rates.
A Lust for Life is a universal school-based multi-component intervention whose target is to build well-being and emotional resilience in adolescents. 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 adolescents' school teacher on a weekly basis. The lessons involve classroom discussions, videos, classroom activities and homework assignments.
Study participants will complete the Adolescent Mental Health Continuum-Short Form, Connor-Davidson Resilience Scale-10, Emotional Literacy and Intervention Inventory-Pupil Checklist, and Mindful Attention Awareness Scale for Children at 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 twelve-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
-
-
Leinster
-
Dublin, Leinster, Ireland
- University College Dublin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adolescent
- Enrolled in primary school in Ireland
- Obtain written informed consent from parents/guardians
- Provide written assent
Exclusion Criteria:
- Failure to the 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 programme group
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.
|
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.
|
Other: Waiting list control group
Participants will be placed on a twelve-week waiting list for the programme.
|
Control group placed on a twelve-week waiting list.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Well-being measured by the Adolescent Mental Health Continuum-Short Form
Time Frame: 6 weeks after beginning intervention: 19/10/2020
|
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
Time Frame: 12 weeks after beginning intervention: 01/12/2020
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resilience measured by the Connor-Davidson Resilience Scale-10
Time Frame: 6 weeks after beginning intervention: 19/10/2020
|
Scores on the Connor-Davidson Resilience Scale-10 range from 0 to 40.
Higher scores indicate greater resilience.
|
6 weeks after beginning intervention: 19/10/2020
|
Resilience measured by the Connor-Davidson Resilience Scale-10
Time Frame: 12 weeks after beginning intervention: 01/12/2020
|
Scores on the Connor-Davidson Resilience Scale-10 range from 0 to 40.
Higher scores indicate greater resilience.
|
12 weeks after beginning intervention: 01/12/2020
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emotional literacy measured by the Emotional Literacy and Intervention Inventory-Pupil Checklist
Time Frame: 6 weeks after beginning intervention: 19/10/2020
|
Scores on the Emotional Literacy and Intervention Inventory-Pupil Checklist are rated on a four-point scale ranging from 'very like me' to 'not like me at all.' Higher scores indicate higher levels of emotional literacy.
|
6 weeks after beginning intervention: 19/10/2020
|
Emotional literacy measured by the Emotional Literacy and Intervention Inventory-Pupil Checklist
Time Frame: 12 weeks after beginning intervention: 01/12/2020
|
Scores on the Emotional Literacy and Intervention Inventory-Pupil Checklist are rated on a four-point scale ranging from 'very like me' to 'not like me at all.' Higher scores indicate higher levels of emotional literacy.
|
12 weeks after beginning intervention: 01/12/2020
|
Mindfulness measured by the Mindful Attention Awareness Scale for Children
Time Frame: 6 weeks after beginning intervention: 19/10/2020
|
Scores on the Mindful Attention Awareness Scale for Children range from 15 to 90.
Items are reverse scored so that higher scores indicate higher levels of mindfulness.
|
6 weeks after beginning intervention: 19/10/2020
|
Mindfulness measured by the Mindful Attention Awareness Scale for Children
Time Frame: 12 weeks after beginning intervention: 01/12/2020
|
Scores on the Mindful Attention Awareness Scale for Children range from 15 to 90.
Items are reverse scored so that higher scores indicate higher levels of mindfulness.
|
12 weeks after beginning intervention: 01/12/2020
|
Satisfaction with the programme measured by the Brief Satisfaction Scale
Time Frame: 6 weeks after beginning intervention: 19/10/2020
|
Scores on each item of the Brief Satisfaction Scale range from 1 to 7. Higher scores indicate greater satisfaction with the programme.
|
6 weeks after beginning intervention: 19/10/2020
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- moconnor1
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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