- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04231604
Evaluation of a School-based Programme Aimed at Promoting Well-being in Adolescents
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Leinster
-
Dublin, Leinster, Irland
- University College Dublin
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Andet: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Well-being measured by the Adolescent Mental Health Continuum-Short Form
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Resilience measured by the Connor-Davidson Resilience Scale-10
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Emotional literacy measured by the Emotional Literacy and Intervention Inventory-Pupil Checklist
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- moconnor1
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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