Well-Being, PsychologicalNCT06135766
Evaluating the Effectiveness of a School-based Intervention to Improve the Wellbeing of Children Aged 10 to 13 Years.
A study testing A Lust for Life in people with Well-Being, Psychological and Child, Only, run by University College Dublin at 1 site in Ireland.
Trial summary
The aim of this study is to evaluate the effectiveness of a universal school-based intervention, which aims to improve the wellbeing of children aged 10 to 13 years, who are attending 5th class or 6th class in primary level education in Ireland. Read more about this study
- Who is it for?
- Ages 10 to 13 years
- Conditions the study is for
- Well-Being, Psychological, Child, Only
- 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
- 300 participants
- Where
- 1 siteIreland
- Study dates
- 31 Aug 2023to 30 Jun 2024
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 10 to 13 years
- Enrolled in primary school in Ireland
- Obtain written informed consent from parents/guardians
- Provide written assent
Who cannot join
- Failure to meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
University College Dublin
Dublin, Leinster, Dublin 4
Alan Carr, Professor, 0035317618740, alan.carr@ucd.ie
About this study
Official title: Evaluation of the Effectiveness of a Universal School-based Intervention to Improve the Wellbeing of Children Aged 10 to 13 Years.
The aim of this study is to evaluate the effectiveness of a universal school-based intervention, which aims to improve the wellbeing of children aged 10 to 13 years, who are attending 5th class or 6th class in primary level education in Ireland.
Read the detailed description
An estimated 10-20% of children and adolescents worldwide experience mental health difficulties, with 50% of difficulties emerging before the age of 14 years. School is an influential environment for young people, with school-based interventions consistently delivering positive mental health and wellbeing programmes in a cost-effective manner.
A Lust for Life (ALFL) is a universal teacher-led programme which aims to build resilience, increase wellbeing, and enhance emotional literacy of 8-13 year old school children. The programme spans ten 40-minute classes. The ALFL curriculum draws on multiple sources including contemporary positive psychology; traditional, second, and third wave cognitive behaviour therapy (CBT); and developmental, educational, and health psychology.
In ALFL children learn the following specific self-regulation skills: naming and rating the intensity of emotions; linking thoughts, feelings and actions; mindfulness; breathing exercises; visualization exercises; progressive muscle relaxation; positive self-talk (gratitude, optimism, and cognitive restructuring); obtaining social support from adults and peers; assertiveness; managing bullying; and using the internet safely. Skills are learned through didactic instruction, video modelling, in-class experiential exercises, and homework practice. The ongoing development of the ALFL programme follows best practice, with the most recently refined programme evaluated in this study.
This quasi-experimental randomized controlled trial study involves an experimental group and a waiting list control group of children aged between 10 and 13 years. All study participants will complete the Feeling Better Scale, Stirling Children's Wellbeing Scale, and Revised Children's Anxiety and Depression Scale at pre-intervention. Participants will complete the questionnaires online. Following this, schools randomly assigned to the experimental group will receive the ALFL programme, while those randomly assigned to the control group will be placed on a 12 week waiting list and receive curriculum as usual. At post-intervention, the questionnaire measures will be completed online by all study participants. The participants in the experimental group will also complete a brief Satisfaction Scale. The waiting list control group will then receive the A Lust for Life programme.
- Conditions
- Well-Being, Psychological, Child, Only
- Being tested
- A Lust for Life, Waiting List Control
- Medical subject headings
- Psychological Well-Being
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 (ALFL) is a universal teacher-led programme which aims to build resilience, increase wellbeing, and enhance emotional literacy of 8-13 year old school children. The programme spans ten 40-minute classes. The ALFL curriculum draws on multiple sources including contemporary positive psychology; traditional, second, and third wave cognitive behaviour therapy (CBT); and developmental, educational, and health psychology. In ALFL children learn the following specific self-regulation skills: naming and rating the intensity of emotions; linking thoughts, feelings and actions; mindfulness; breathing exercises; visualization exercises; progressive muscle relaxation; positive self-talk (gratitude, optimism, and cognitive restructuring); obtaining social support from adults and peers; assertiveness; managing bullying; and using the internet safely. Skills are learned through didactic instruction, video modelling, in-class experiential exercises, and homework practice.
Waiting List ControlBehavioural
Control group placed on a 12-week waiting list for the A Lust for Life (ALFL) programme.
| Study group | Role | What they receive |
|---|---|---|
| A Lust for Life programme group | Experimental | A Lust for Life programme will be delivered to participants by their class teachers in ten weekly sessions. Receives: Behavioral: A Lust for Life |
| Waiting list control group | Other | Participants will receive curriculum as usual from their class teacher, and placed on a 12-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.
Wellbeing measured by the Feeling Better Scale
Scores on the Feeling Better Scale range from 0 to 152. Higher scores indicate higher levels of wellbeing.
Measured: 10 weeks after beginning the intervention
Secondary outcomes (3)
Wellbeing measured by the Stirling Children's Wellbeing Scale
Scores on the Stirling Children's Wellbeing Scale range from 12 to 60. Higher scores indicate higher wellbeing.
Measured: 10 weeks after beginning the intervention
Anxiety and low mood measured by the Revised Children's Anxiety and Depression Scale
Scores on the Revised Children's Anxiety and Depression Scale range from 0 to 75. Higher scores indicate greater severity of anxiety and low mood.
Measured: 10 weeks after beginning the intervention
Programme satisfaction with the Satisfaction Scale
Scores on the Satisfaction Scale range from 8 to 56. Higher scores indicate higher satisfaction
Measured: 10 weeks after beginning the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start31 Aug 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-Being, PsychologicalStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan Carr, Professor, Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135766
- Sponsor's protocol ID
- HS-22-80-Carr2
- Status last verified
- Jan 2024
- First submitted
- 13 Nov 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Universal School-based Intervention to Improve the Wellbeing of Children Aged 10 to 13 Years.
- ClinicalTrials.gov ID
- NCT06135766
- Acronym / sponsor ID
- HS-22-80-Carr2
- Conditions
- Well-Being, Psychological, Child, Only
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 18 Nov 2023 (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 study is to evaluate the effectiveness of a universal school-based intervention, which aims to improve the wellbeing of children aged 10 to 13 years, who are attending 5th class or 6th class in primary level education in Ireland.
Detailed description
An estimated 10-20% of children and adolescents worldwide experience mental health difficulties, with 50% of difficulties emerging before the age of 14 years. School is an influential environment for young people, with school-based interventions consistently delivering positive mental health and wellbeing programmes in a cost-effective manner.
A Lust for Life (ALFL) is a universal teacher-led programme which aims to build resilience, increase wellbeing, and enhance emotional literacy of 8-13 year old school children. The programme spans ten 40-minute classes. The ALFL curriculum draws on multiple sources including contemporary positive psychology; traditional, second, and third wave cognitive behaviour therapy (CBT); and developmental, educational, and health psychology.
In ALFL children learn the following specific self-regulation skills: naming and rating the intensity of emotions; linking thoughts, feelings and actions; mindfulness; breathing exercises; visualization exercises; progressive muscle relaxation; positive self-talk (gratitude, optimism, and cognitive restructuring); obtaining social support from adults and peers; assertiveness; managing bullying; and using the internet safely. Skills are learned through didactic instruction, video modelling, in-class experiential exercises, and homework practice. The ongoing development of the ALFL programme follows best practice, with the most recently refined programme evaluated in this study.
This quasi-experimental randomized controlled trial study involves an experimental group and a waiting list control group of children aged between 10 and 13 years. All study participants will complete the Feeling Better Scale, Stirling Children's Wellbeing Scale, and Revised Children's Anxiety and Depression Scale at pre-intervention. Participants will complete the questionnaires online. Following this, schools randomly assigned to the experimental group will receive the ALFL programme, while those randomly assigned to the control group will be placed on a 12 week waiting list and receive curriculum as usual. At post-intervention, the questionnaire measures will be completed online by all study participants. The participants in the experimental group will also complete a brief Satisfaction Scale. The waiting list control group will then receive the A Lust for Life programme.
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 participants by their class teachers in ten weekly sessions. |
| Waiting list control group | Other | Behavioral: Waiting List ControlParticipants will receive curriculum as usual from their class teacher, and placed on a 12-week waiting list for the programme. |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 10 to 13 years
- Enrolled in primary school in Ireland
- Obtain written informed consent from parents/guardians
- Provide written assent
Key exclusion criteria (1 listed)
- Failure to 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 (ALFL) is a universal teacher-led programme which aims to build resilience, increase wellbeing, and enhance emotional literacy of 8-13 year old school children. The programme spans ten 40-minute classes. The ALFL curriculum draws on multiple sources including contemporary positive psychology; traditional, second, and third wave cognitive behaviour therapy (CBT); and developmental, educational, and health psychology. In ALFL children learn the following specific self-regulation skills: naming and rating the intensity of emotions; linking thoughts, feelings and actions; mindfulness; breathing exercises; visualization exercises; progressive muscle relaxation; positive self-talk (gratitude, optimism, and cognitive restructuring); obtaining social support from adults and peers; assertiveness; managing bullying; and using the internet safely. Skills are learned through didactic instruction, video modelling, in-class experiential exercises, and homework practice. | Behavioural | A Lust for Life programme group |
| Waiting List ControlControl group placed on a 12-week waiting list for the A Lust for Life (ALFL) programme. | Behavioural | Waiting list control group |
Primary outcome
Wellbeing measured by the Feeling Better Scale
Time frame: 10 weeks after beginning the intervention
Scores on the Feeling Better Scale range from 0 to 152. Higher scores indicate higher levels of wellbeing.
3 secondary outcomes
Wellbeing measured by the Stirling Children's Wellbeing Scale
Time frame: 10 weeks after beginning the intervention
Anxiety and low mood measured by the Revised Children's Anxiety and Depression Scale
Time frame: 10 weeks after beginning the intervention
Programme satisfaction with the Satisfaction Scale
Time frame: 10 weeks after beginning the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- 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.
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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.
Alan Carr, Professor principal investigator
University College Dublin
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 Well-Being, Psychological and Child, Only, 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alan Carr, Professor (0035317168740, alan.carr@ucd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wellbeing measured by the Feeling Better Scale (time frame: 10 weeks after beginning the intervention). 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 18 Jan 2024.