- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07771972
Life Skills Training for Anxiety and Football Performance in Adolescent Players (LST-Football)
Life Skills Training and Athletic Performance of Non-Elite Adolescent Football Players: The Mediating Role of Reduced Cognitive Anxiety
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The study will use a two-arm parallel longitudinal randomized design with three assessment points: T0 at baseline, T1 immediately after completion of an eight-week intervention, and T2 four weeks after T1. Participants will be 160 non-elite football players aged 14-17 years from 16 teams. Individual randomization will be conducted within team-by-gender strata using a computer-generated random sequence, targeting 80 participants per condition.
The life skills intervention will consist of 16 sessions delivered over eight weeks (two sessions per week; 45-60 minutes per session; approximately 8-10 players per small group). Content will include goal setting, self-management, emotional regulation, problem solving, decision making, communication, teamwork, time management, coping with mistakes, and transfer of skills beyond sport. Control participants will continue usual football training without the structured life skills program during the study period. Attendance, possible control contamination, and concurrent psychological training will be recorded.
Cognitive sport anxiety will be assessed using the 15-item Sport Anxiety Scale-2. Worry will comprise items 3, 5, 8, 9, and 11; Concentration Disruption will comprise items 1, 4, 7, 13, and 15; Somatic Anxiety will comprise items 2, 6, 10, 12, and 14. Cognitive Anxiety will be defined as Worry plus Concentration Disruption. Football performance will be assessed using passing accuracy, shooting accuracy, dribbling time, and agility time. These components will be standardized using fixed baseline reference parameters, with time-based measures reverse-directed, and combined into a T-score Football Performance Index in which higher values indicate better performance.
Primary intervention effects will be evaluated with linear mixed-effects models using condition, time, and condition-by-time fixed effects, while accounting for repeated observations within participants and clustering within teams. Secondary outcome contrasts will be adjusted using the Holm procedure. The longitudinal indirect pathway will be evaluated as intervention allocation → T1 cognitive anxiety reduction → T2 football performance. The indirect effect will be estimated with 5,000 team-cluster bootstrap resamples. Sensitivity analyses will include per-protocol attendance, control contamination, concurrent psychological training, complete T2 cases, multiple imputation with 20 imputed datasets, and alternative FPI scoring.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Yang Qin, Assistant Professor
- Numéro de téléphone: +869183336007
- E-mail: qinyang@tjus.edu.cni@iau.ir
Sauvegarde des contacts de l'étude
- Nom: Jiarui Xing, assistant professor
- E-mail: xingjrrr@sina.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
- Age 14 to 17 years at enrollment.
- Current membership in a non-elite/non-professional football team.
- At least one year of prior football participation.
- Regular participation in team football training.
- Ability and willingness to attend study assessments and, if allocated to the intervention, the life skills training sessions.
- Written informed consent from a parent or legal guardian and age-appropriate assent from the adolescent participant before study participation.
Exclusion Criteria:
- Current membership in a national football team.
- Current professional football contract.
- Current membership in a first-tier professional football academy.
- Any medical, musculoskeletal, or psychological condition that, in the judgment of the study team, would make participation in football-performance testing or the behavioral intervention unsafe or inappropriate.
- Inability to complete baseline assessment or comply with essential study procedures.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Life Skills Training
Participants will receive a structured eight-week life skills training program consisting of 16 small-group sessions delivered twice weekly.
Each session will last 45-60 minutes and will involve approximately 8-10 players.
Training will address goal setting, self-management, emotional regulation, problem solving, decision making, communication, teamwork, time management, coping with mistakes, and transfer of skills beyond sport.
|
An eight-week behavioral life skills program delivered in 16 small-group sessions (2 sessions/week; 45-60 minutes/session; approximately 8-10 players/group).
The program will include goal setting, self-management, emotional regulation, problem solving, decision making, communication, teamwork, time management, coping with mistakes, and transfer of skills beyond sport.
Attendance will be recorded.
Per-protocol adherence will be defined as attendance at ≥80% of sessions (at least 13 of 16 sessions).
|
|
Aucune intervention: Usual Training Control
Participants will continue their usual football training during the eight-week study intervention period and will not receive the structured life skills training program.
Potential exposure to intervention content and concurrent psychological training will be monitored.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Cognitive Anxiety Score
Délai: Baseline (T0), immediately post-intervention at 8 weeks (T1), and 4-week post-intervention follow-up (T2; approximately 12 weeks after baseline)
|
Cognitive Anxiety will be calculated as the sum of the Worry and Concentration Disruption subscales of the 15-item Sport Anxiety Scale-2.
Each subscale contains five items scored from 1 to 4; therefore the Cognitive Anxiety composite will range from 10 to 40, with lower scores indicating less cognitive sport anxiety.
The primary analysis will evaluate differential change between groups over time.
|
Baseline (T0), immediately post-intervention at 8 weeks (T1), and 4-week post-intervention follow-up (T2; approximately 12 weeks after baseline)
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Change in Baseline-Referenced Football Performance Index
Délai: Baseline (T0), immediately post-intervention at 8 weeks (T1), and 4-week post-intervention follow-up (T2; approximately 12 weeks after baseline)
|
The Football Performance Index will combine passing accuracy, shooting accuracy, dribbling time, and agility time.
Each component will be standardized using fixed baseline reference parameters; dribbling and agility time will be reverse-directed so higher standardized values represent better performance.
The composite will be transformed to a T-score metric, with higher scores indicating better football performance.
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Baseline (T0), immediately post-intervention at 8 weeks (T1), and 4-week post-intervention follow-up (T2; approximately 12 weeks after baseline)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Worry Subscale Score
Délai: Time frame: T0, T1 at 8 weeks, T2 at approximately 12 weeks.
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5-item SAS-2 Worry subscale; range 5-20; lower scores indicate less worry.
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Time frame: T0, T1 at 8 weeks, T2 at approximately 12 weeks.
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Concentration Disruption Subscale Score
Délai: Time frame: T0, T1 at 8 weeks, T2 at approximately 12 weeks.
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5-item SAS-2 Concentration Disruption subscale; range 5-20; lower scores indicate less concentration disruption.
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Time frame: T0, T1 at 8 weeks, T2 at approximately 12 weeks.
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Somatic Anxiety Subscale Score
Délai: Time frame: T0, T1 at 8 weeks, T2 at approximately 12 weeks.
|
5-item SAS-2 Somatic Anxiety subscale; range 5-20; lower scores indicate less somatic anxiety.
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Time frame: T0, T1 at 8 weeks, T2 at approximately 12 weeks.
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Passing Accuracy
Délai: ime frame: T0, T1 at 8 weeks, T2 at approximately 12 weeks.
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Football-specific passing accuracy performance measure; higher values indicate better performance.
|
ime frame: T0, T1 at 8 weeks, T2 at approximately 12 weeks.
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
Mots clés
Autres numéros d'identification d'étude
- TUS-LST-22FTYB009-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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