AdolescentsNCT04850872
PLAYwithHEART: PLAY With Happiness, Engagement, Acceptance, and Respect With Your Team
A study testing PLAYwithHEART Programme for adolescent athletes in people with Adolescents and Athletes, run by University of Coimbra at 1 site in Portugal.
Trial summary
This investigation aims to apply and test the feasibility of a structured Program for young athletes. PLAYwithHEART is a program for promoting acceptance and cooperation skills in adolescent athletes. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Adolescents, Athletes
- What is being tested?
- PLAYwithHEART Programme for adolescent athletes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Feb 2020to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PLAYwithHEART: Development and Feasibility Study of a Program for the Promotion of Acceptance and Cooperation Skills for Adolescent Athletes
This investigation aims to apply and test the feasibility of a structured Program for young athletes. PLAYwithHEART is a program for promoting acceptance and cooperation skills in adolescent athletes. This group application program comprises eight weekly sessions and aims to decrease levels of sport anxiety, and increase the psychological quality of life of young athletes, by promoting skills inherent to an affiliation mentality (mindfulness, acceptance, and compassion), as an alternative to a social ranking mentality (based on maladaptive processes, such as shame and self-criticism), to deal with the challenges and demands of the sport context.
Read the 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).
- Conditions
- Adolescents, Athletes
- Being tested
- PLAYwithHEART Programme for adolescent athletes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLAYwithHEART Programme for adolescent athletesBehavioural
PLAYwithHEART programme for adolescent athletes is an intervention programme based on Mindfulness, Acceptance, and Compassion for adolescent athletes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: PLAYwithHEART Programme for adolescent athletes |
| Control | No intervention | Participants of control group do not receive the intervention Programme (PLAYwithHEART), nor any other program, and only complete self-report measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Quality of Life
Measured by the The KIDSCREEN-10 quality of life measure for children and adolescents - higher levels mean a better outcome
Measured: From baseline to 6-months follow-up
Changes in competitive anxiety
Measured by the Sport Anxiety Scale (SAS-2) - lower levels mean a better outcome
Measured: From baseline to 6-months follow-up
Secondary outcomes (5)
Changes in Mindfulness
Measured by the Children´s Acceptance and Mindfulness Measure (CAMM) - higher levels mean a better outcome
Measured: From baseline to 6-months follow-up
Changes in Psychological Inflexibility
Measured by the Avoidance and Fusion Questionnaire for Youth (AFQ-Y) - lower levels mean a better outcome
Measured: From baseline to 6-months follow-up
Changes in Self-compassion
Measured by the Self-Compassion Scale (SCS-A) - higher levels mean a better outcome
Measured: From baseline to 6-months follow-up
Changes in shame
Measured by the External and Internal Shame Scale for adolescents (EISS-A). Lower scores mean a better outcome
Measured: From baseline to 6-months follow-up
Changes in self-criticism
Measured by the Forms of self-criticizing/attacking and self-reassuring scale (FSCRS-A) - lower scores in self-criticising mean a better outcome
Measured: From baseline to 6-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 Feb 2020
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdolescentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Oliveira, University of Coimbra
- Investigators
- Sara Oliveira, MS, Principal investigator, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850872
- Sponsor's protocol ID
- CINEICC
- Other IDs
- SFRH/BD/143410/2019
- Status last verified
- Mar 2024
- First submitted
- 14 Apr 2021
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLAYwithHEART: Development and Feasibility Study of a Program for the Promotion of Acceptance and Cooperation Skills for Adolescent Athletes
- ClinicalTrials.gov ID
- NCT04850872
- Acronym / sponsor ID
- CINEICC
- Conditions
- Adolescents, Athletes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation aims to apply and test the feasibility of a structured Program for young athletes. PLAYwithHEART is a program for promoting acceptance and cooperation skills in adolescent athletes. This group application program comprises eight weekly sessions and aims to decrease levels of sport anxiety, and increase the psychological quality of life of young athletes, by promoting skills inherent to an affiliation mentality (mindfulness, acceptance, and compassion), as an alternative to a social ranking mentality (based on maladaptive processes, such as shame and self-criticism), to deal with the challenges and demands of the sport context.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: PLAYwithHEART Programme for adolescent athletesPLAYwithHEART 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. |
| Control | No intervention | –Participants of control group do not receive the intervention Programme (PLAYwithHEART), nor any other program, and only complete self-report measures. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLAYwithHEART Programme for adolescent athletesPLAYwithHEART programme for adolescent athletes is an intervention programme based on Mindfulness, Acceptance, and Compassion for adolescent athletes | Behavioural | Experimental |
Primary outcome
Changes in Quality of Life
Time frame: From baseline to 6-months follow-up
Measured by the The KIDSCREEN-10 quality of life measure for children and adolescents - higher levels mean a better outcome
Changes in competitive anxiety
Time frame: From baseline to 6-months follow-up
Measured by the Sport Anxiety Scale (SAS-2) - lower levels mean a better outcome
5 secondary outcomes
Changes in Mindfulness
Time frame: From baseline to 6-months follow-up
Changes in Psychological Inflexibility
Time frame: From baseline to 6-months follow-up
Changes in Self-compassion
Time frame: From baseline to 6-months follow-up
Changes in shame
Time frame: From baseline to 6-months follow-up
Changes in self-criticism
Time frame: From baseline to 6-months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Oliveira, MS principal investigator
University of Coimbra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLAYwithHEART Programme for adolescent athletes in people with Adolescents and Athletes, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Quality of Life (time frame: From baseline to 6-months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.