- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04850872
PLAYwithHEART: PLAY With Happiness, Engagement, Acceptance, and Respect With Your Team
PLAYwithHEART: Development and Feasibility Study of a Program for the Promotion of Acceptance and Cooperation Skills for Adolescent Athletes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The sample will include young athletes of different sports with ages ranged 12 to 18 years old. The principal investigator will recruit participants through contact with different sports clubs in Portugal. Athletes who demonstrate interest will go through a Screening interview (previously authorized by your legal guardian) by a licensed psychologist that aims explain the structure and arms of the investigation, to collect demographic data, and whether the athlete meets the inclusion criteria for the study. Athletes who meet the inclusion criteria and demonstrate interest in participating in the study, will sign an informed consent.
All ethical requirements for research with humans are guaranteed. Afterwards, participants will be allocated in two groups (experimental and control group). Additionally, the experimental group will enroll in the PLAYwithHEART programme, also provided by a licensed psychologist and a co-therapist.
Both groups will concurrently complete a protocol of self-report measures (to measure: a) psychological processes; b) quality of life and sports anxiety. These assessments will occur in three different times: before the start of the PLAYwithHEART programme (M0), after the final session of the programme (M1), and 6 months after that (M2).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
-
Coimbra, Portugal
- Different sports clubs in Portugal
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- adolescent competitive athletes
- presentation of the informed consent signed by the participant and respetive legal guardian
- availability to participate in the 8 sessions of the PLAYwithHEART Programme
- inexistence of cognitive difficulties that interfere in completing self-response measures
- not being under psychological / psychiatric appointments
Exclusion Criteria:
- no presentation of the informed consent signed by the participant and respetive legal guardian
- unavailability to participate in the 8 sessions of the PLAYwithHEART Programme
- existence of cognitive difficulties that interfere in completing self-response measures
- being under psychological / psychiatric appointments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental
PLAYwithHEART Programme is a manualized mindfulness, acceptance, and compassionate-based group intervention for adolescent competitive athletes.
It included 8 weekly group sessions, 45 minutes each, run in small groups (ranging from 8 to 12 participants).
Participants of this group complete also self-report measures.
|
PLAYwithHEART programme for adolescent athletes is an intervention programme based on Mindfulness, Acceptance, and Compassion for adolescent athletes
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No Intervention: Control
Participants of control group do not receive the intervention Programme (PLAYwithHEART), nor any other program, and only complete self-report measures.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Quality of Life
Time Frame: From baseline to 6-months follow-up
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Measured by the The KIDSCREEN-10 quality of life measure for children and adolescents - higher levels mean a better outcome
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From baseline to 6-months follow-up
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Changes in competitive anxiety
Time Frame: From baseline to 6-months follow-up
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Measured by the Sport Anxiety Scale (SAS-2) - lower levels mean a better outcome
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From baseline to 6-months follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Mindfulness
Time Frame: From baseline to 6-months follow-up
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Measured by the Children´s Acceptance and Mindfulness Measure (CAMM) - higher levels mean a better outcome
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From baseline to 6-months follow-up
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Changes in Self-compassion
Time Frame: From baseline to 6-months follow-up
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Measured by the Self-Compassion Scale (SCS-A) - higher levels mean a better outcome
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From baseline to 6-months follow-up
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Changes in shame
Time Frame: From baseline to 6-months follow-up
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Measured by the External and Internal Shame Scale for adolescents (EISS-A).
Lower scores mean a better outcome
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From baseline to 6-months follow-up
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Changes in self-criticism
Time Frame: From baseline to 6-months follow-up
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Measured by the Forms of self-criticizing/attacking and self-reassuring scale (FSCRS-A) - lower scores in self-criticising mean a better outcome
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From baseline to 6-months follow-up
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Changes in Psychological Inflexibility
Time Frame: From baseline to 6-months follow-up
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Measured by the Avoidance and Fusion Questionnaire for Youth (AFQ-Y) - lower levels mean a better outcome
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From baseline to 6-months follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sara Oliveira, MS, University of Coimbra
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CINEICC
- SFRH/BD/143410/2019 (Other Grant/Funding Number: Fundação para a Ciência e Tecnologia)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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