- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04231604
Evaluation of a School-based Programme Aimed at Promoting Well-being in Adolescents
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Leinster
-
Dublin, Leinster, Irlande
- University College Dublin
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Autre: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Well-being measured by the Adolescent Mental Health Continuum-Short Form
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Resilience measured by the Connor-Davidson Resilience Scale-10
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Emotional literacy measured by the Emotional Literacy and Intervention Inventory-Pupil Checklist
Délai: 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
|
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Emotional literacy measured by the Emotional Literacy and Intervention Inventory-Pupil Checklist
Délai: 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
Délai: 6 weeks after beginning intervention: 19/10/2020
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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
Délai: 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
|
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Satisfaction with the programme measured by the Brief Satisfaction Scale
Délai: 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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Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
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Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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