- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Yang Qin, Assistant Professor
- Numer telefonu: +869183336007
- E-mail: qinyang@tjus.edu.cni@iau.ir
Kopia zapasowa kontaktu do badania
- Nazwa: Jiarui Xing, assistant professor
- E-mail: xingjrrr@sina.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
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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).
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Brak interwencji: 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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Cognitive Anxiety Score
Ramy czasowe: 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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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.
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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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Change in Baseline-Referenced Football Performance Index
Ramy czasowe: 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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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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Worry Subscale Score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Time frame: T0, T1 at 8 weeks, T2 at approximately 12 weeks.
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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
Ramy czasowe: 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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Współpracownicy i badacze
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
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
Słowa kluczowe
Inne numery identyfikacyjne badania
- TUS-LST-22FTYB009-01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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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