- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04231604
Evaluation of a School-based Programme Aimed at Promoting Well-being in Adolescents
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Leinster
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Dublin, Leinster, Irlandia
- University College Dublin
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
|
|
Inny: Waiting list control group
Participants will be placed on a twelve-week waiting list for the programme.
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Control group placed on a twelve-week waiting list.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Well-being measured by the Adolescent Mental Health Continuum-Short Form
Ramy czasowe: 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.
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6 weeks after beginning intervention: 19/10/2020
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Well-being measured by the Adolescent Mental Health Continuum-Short Form
Ramy czasowe: 12 weeks after beginning intervention: 01/12/2020
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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
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Resilience measured by the Connor-Davidson Resilience Scale-10
Ramy czasowe: 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
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Resilience measured by the Connor-Davidson Resilience Scale-10
Ramy czasowe: 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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Emotional literacy measured by the Emotional Literacy and Intervention Inventory-Pupil Checklist
Ramy czasowe: 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.
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6 weeks after beginning intervention: 19/10/2020
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Emotional literacy measured by the Emotional Literacy and Intervention Inventory-Pupil Checklist
Ramy czasowe: 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.
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12 weeks after beginning intervention: 01/12/2020
|
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Mindfulness measured by the Mindful Attention Awareness Scale for Children
Ramy czasowe: 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.
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6 weeks after beginning intervention: 19/10/2020
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Mindfulness measured by the Mindful Attention Awareness Scale for Children
Ramy czasowe: 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
Ramy czasowe: 6 weeks after beginning intervention: 19/10/2020
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Scores on each item of the Brief Satisfaction Scale range from 1 to 7. Higher scores indicate greater satisfaction with the programme.
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6 weeks after beginning intervention: 19/10/2020
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- moconnor1
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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