Adolescent Well-BeingNCT04231604
Evaluation of a School-based Programme Aimed at Promoting Well-being in Adolescents
A study testing A Lust for Life in people with Adolescent Well-Being and Resilience, Psychological, run by University College Dublin at 1 site in Ireland.
Trial summary
The aim of this pilot study is to evaluate a universal school-based multi-component intervention whose target is to build well-being and emotional resilience in adolescents. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Adolescent Well-Being, Resilience, Psychological
- What is being tested?
- A Lust for Life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 604 participants
- Where
- 1 siteIreland
- Study dates
- 17 Jan 2020to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent
- Enrolled in primary school in Ireland
- Obtain written informed consent from parents/guardians
- Provide written assent
Who cannot join
- Failure to the meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this pilot study is to evaluate a universal school-based multi-component intervention whose target is to build well-being and emotional resilience in adolescents.
Read the 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.
- Conditions
- Adolescent Well-Being, Resilience, Psychological
- Being tested
- A Lust for Life, Waiting list control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Lust for LifeBehavioural
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.
Waiting list controlBehavioural
Control group placed on a twelve-week waiting list.
| Study group | Role | What they receive |
|---|---|---|
| A Lust for Life programme group | Experimental | 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. Receives: Behavioral: A Lust for Life |
| Waiting list control group | Other | Participants will be placed on a twelve-week waiting list for the programme. Receives: Behavioral: Waiting list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Well-being measured by the Adolescent Mental Health Continuum-Short Form
Scores on the Adolescent Mental Health Continuum-Short Form range from 14 to 84. Higher scores indicate lower well-being.
Measured: 6 weeks after beginning intervention: 19/10/2020
Well-being measured by the Adolescent Mental Health Continuum-Short Form
Scores on the Adolescent Mental Health Continuum-Short Form range from 14 to 84. Higher scores indicate lower well-being.
Measured: 12 weeks after beginning intervention: 01/12/2020
Secondary outcomes (2)
Resilience measured by the Connor-Davidson Resilience Scale-10
Scores on the Connor-Davidson Resilience Scale-10 range from 0 to 40. Higher scores indicate greater resilience.
Measured: 6 weeks after beginning intervention: 19/10/2020
Resilience measured by the Connor-Davidson Resilience Scale-10
Scores on the Connor-Davidson Resilience Scale-10 range from 0 to 40. Higher scores indicate greater resilience.
Measured: 12 weeks after beginning intervention: 01/12/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start17 Jan 2020
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Well-BeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231604
- Sponsor's protocol ID
- moconnor1
- Status last verified
- Sep 2021
- First submitted
- 7 Jan 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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 well-being, resilience, emotional literacy and mindfulness.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a School-based Programme Aimed at Promoting Well-being in Adolescents
- ClinicalTrials.gov ID
- NCT04231604
- Acronym / sponsor ID
- moconnor1
- Conditions
- Adolescent Well-Being, Resilience, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this pilot study is to evaluate a universal school-based multi-component intervention whose target is to build well-being and emotional resilience in adolescents.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Lust for Life programme group | Experimental | Behavioral: A Lust for LifeA 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. |
| Waiting list control group | Other | Behavioral: Waiting list controlParticipants will be placed on a twelve-week waiting list for the programme. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adolescent
- Enrolled in primary school in Ireland
- Obtain written informed consent from parents/guardians
- Provide written assent
Key exclusion criteria (1 listed)
- Failure to the meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Lust for LifeA 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. | Behavioural | A Lust for Life programme group |
| Waiting list controlControl group placed on a twelve-week waiting list. | Behavioural | Waiting list control group |
Primary outcome
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.
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.
2 secondary outcomes
Resilience measured by the Connor-Davidson Resilience Scale-10
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: Yes. 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 well-being, resilience, emotional literacy and mindfulness.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Lust for Life in people with Adolescent Well-Being and Resilience, Psychological, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Well-being measured by the Adolescent Mental Health Continuum-Short Form (time frame: 6 weeks after beginning intervention: 19/10/2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.