Clinical trial NCT05061381: Effectiveness of a School Wellbeing Programme for Internalising Problems in Irish Primary School Children
Official title: Evaluating the Impact of a School Wellbeing Programme on Internalising Problems in Primary School Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Low Mood
Lead sponsor: University College Dublin
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 400
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptoms of anxiety and low mood measured by the Revised Children's Anxiety and Depression Scale Short Form
timeFrame: 16 weeks
Secondary outcomes:
measure: Coping skills as measured by the Coping Strategy Indicator
timeFrame: 16 weeks
measure: Self-efficacy as measured by the Self-Efficacy Questionnaire for Children
timeFrame: 16 weeks
Other outcomes:
measure: Satisfaction with the programme measured by the Brief Satisfaction Scale
timeFrame: 10 weeks
Locations:
city: Dublin
country: Ireland
facility: University College Dublin
state: Tipperary
Study officials:
affiliation: University College Dublin
name: Aoife Clancy
role: PRINCIPAL_INVESTIGATOR
References: