- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04231604
Evaluation of a School-based Programme Aimed at Promoting Well-being in Adolescents
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Leinster
-
Dublin, Leinster, Irland
- University College Dublin
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Adolescent
- Enrolled in primary school in Ireland
- Obtain written informed consent from parents/guardians
- Provide written assent
Exclusion Criteria:
- Failure to the meet inclusion criteria
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: A Lust for Life programme group
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.
|
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.
|
|
Övrig: Waiting list control group
Participants will be placed on a twelve-week waiting list for the programme.
|
Control group placed on a twelve-week waiting list.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Well-being measured by the Adolescent Mental Health Continuum-Short Form
Tidsram: 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.
|
6 weeks after beginning intervention: 19/10/2020
|
|
Well-being measured by the Adolescent Mental Health Continuum-Short Form
Tidsram: 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.
|
12 weeks after beginning intervention: 01/12/2020
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Resilience measured by the Connor-Davidson Resilience Scale-10
Tidsram: 6 weeks after beginning intervention: 19/10/2020
|
Scores on the Connor-Davidson Resilience Scale-10 range from 0 to 40.
Higher scores indicate greater resilience.
|
6 weeks after beginning intervention: 19/10/2020
|
|
Resilience measured by the Connor-Davidson Resilience Scale-10
Tidsram: 12 weeks after beginning intervention: 01/12/2020
|
Scores on the Connor-Davidson Resilience Scale-10 range from 0 to 40.
Higher scores indicate greater resilience.
|
12 weeks after beginning intervention: 01/12/2020
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Emotional literacy measured by the Emotional Literacy and Intervention Inventory-Pupil Checklist
Tidsram: 6 weeks after beginning intervention: 19/10/2020
|
Scores on the Emotional Literacy and Intervention Inventory-Pupil Checklist are rated on a four-point scale ranging from 'very like me' to 'not like me at all.' Higher scores indicate higher levels of emotional literacy.
|
6 weeks after beginning intervention: 19/10/2020
|
|
Emotional literacy measured by the Emotional Literacy and Intervention Inventory-Pupil Checklist
Tidsram: 12 weeks after beginning intervention: 01/12/2020
|
Scores on the Emotional Literacy and Intervention Inventory-Pupil Checklist are rated on a four-point scale ranging from 'very like me' to 'not like me at all.' Higher scores indicate higher levels of emotional literacy.
|
12 weeks after beginning intervention: 01/12/2020
|
|
Mindfulness measured by the Mindful Attention Awareness Scale for Children
Tidsram: 6 weeks after beginning intervention: 19/10/2020
|
Scores on the Mindful Attention Awareness Scale for Children range from 15 to 90.
Items are reverse scored so that higher scores indicate higher levels of mindfulness.
|
6 weeks after beginning intervention: 19/10/2020
|
|
Mindfulness measured by the Mindful Attention Awareness Scale for Children
Tidsram: 12 weeks after beginning intervention: 01/12/2020
|
Scores on the Mindful Attention Awareness Scale for Children range from 15 to 90.
Items are reverse scored so that higher scores indicate higher levels of mindfulness.
|
12 weeks after beginning intervention: 01/12/2020
|
|
Satisfaction with the programme measured by the Brief Satisfaction Scale
Tidsram: 6 weeks after beginning intervention: 19/10/2020
|
Scores on each item of the Brief Satisfaction Scale range from 1 to 7. Higher scores indicate greater satisfaction with the programme.
|
6 weeks after beginning intervention: 19/10/2020
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
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