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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05061381
Other study ID # aclancy
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 11, 2021
Est. completion date November 30, 2022

Study information

Verified date July 2022
Source University College Dublin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 400
Est. completion date November 30, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
A Lust for Life Schools Programme
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.

Locations

Country Name City State
Ireland University College Dublin Dublin Tipperary

Sponsors (1)

Lead Sponsor Collaborator
University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Other Satisfaction with the programme measured by the Brief Satisfaction Scale Scores on each item of the Brief Satisfaction Scale range from 1 to 7 10 weeks
Primary 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. 16 weeks
Secondary Coping skills as measured by the Coping Strategy Indicator 33-item measure that measures three coping factors: seeking social support, problem-solving, and avoidance. 16 weeks
Secondary Self-efficacy as measured by the Self-Efficacy Questionnaire for Children 24-item questionnaire that measures three factors: academic, social and emotional self-efficacy. 16 weeks
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