AnxietyNCT05061381
Effectiveness of a School Wellbeing Programme for Internalising Problems in Irish Primary School Children
A study testing A Lust for Life Schools Programme in people with Anxiety and Low Mood, run by University College Dublin at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- What is being tested?
- A Lust for Life Schools Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteIreland
- Study dates
- 11 Oct 2021to 30 Nov 2022
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Child
- 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.
About this study
Official title: Evaluating the Impact of a School Wellbeing Programme on Internalising Problems in Primary School Children
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.
Read the 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.
- Being tested
- A Lust for Life Schools Programme
- Medical subject headings
- Anxiety Disorders, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Lust for Life Schools ProgrammeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| A Lust for Life Schools Programme Group | Experimental | 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. Receives: Behavioral: A Lust for Life Schools Programme |
| Waiting list control group | No intervention | Participants will be placed on a sixteen-week waiting list for the programme. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (2)
Coping skills as measured by the Coping Strategy Indicator
33-item measure that measures three coping factors: seeking social support, problem-solving, and avoidance.
Measured: 16 weeks
Self-efficacy as measured by the Self-Efficacy Questionnaire for Children
24-item questionnaire that measures three factors: academic, social and emotional self-efficacy.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start11 Oct 2021
- Primary completion1 Jul 2022
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aoife Clancy, Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061381
- Sponsor's protocol ID
- aclancy
- Status last verified
- Jul 2022
- First submitted
- 7 Sep 2021
- Last updated
- 4 Nov 2022
- 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 anxiety, depression, coping skills and self-efficacy.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of a School Wellbeing Programme on Internalising Problems in Primary School Children
- ClinicalTrials.gov ID
- NCT05061381
- Acronym / sponsor ID
- aclancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 29 Sep 2021 (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 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.
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 Schools Programme Group | Experimental | Behavioral: A Lust for Life Schools ProgrammeA 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. |
| Waiting list control group | No intervention | –Participants will be placed on a sixteen-week waiting list for the programme. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Child
- 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 Life Schools ProgrammeA 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. | Behavioural | A Lust for Life Schools Programme Group |
Primary outcome
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.
2 secondary outcomes
Coping skills as measured by the Coping Strategy Indicator
Time frame: 16 weeks
Self-efficacy as measured by the Self-Efficacy Questionnaire for Children
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- 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 anxiety, depression, coping skills and self-efficacy.
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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.
Aoife Clancy 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 Schools Programme in people with Anxiety and Low Mood, 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 4 Nov 2022. 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?
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?
Symptoms of anxiety and low mood measured by the Revised Children's Anxiety and Depression Scale Short Form (time frame: 16 weeks). 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 4 Nov 2022.