PLAYwithHEART: PLAY With Happiness, Engagement, Acceptance, and Respect With Your Team

March 19, 2024 updated by: Sara Oliveira, University of Coimbra

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Coimbra, Portugal
        • Different sports clubs in Portugal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: PLAYwithHEART Programme for adolescent athletes
PLAYwithHEART programme for adolescent athletes is an intervention programme based on Mindfulness, Acceptance, and Compassion for adolescent athletes
No Intervention: Control
Participants of control group do not receive the intervention Programme (PLAYwithHEART), nor any other program, and only complete self-report measures.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From baseline to 6-months follow-up
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
From baseline to 6-months follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Mindfulness
Time Frame: From baseline to 6-months follow-up
Measured by the Children´s Acceptance and Mindfulness Measure (CAMM) - higher levels mean a better outcome
From baseline to 6-months follow-up
Changes in Self-compassion
Time Frame: From baseline to 6-months follow-up
Measured by the Self-Compassion Scale (SCS-A) - higher levels mean a better outcome
From baseline to 6-months follow-up
Changes in shame
Time Frame: From baseline to 6-months follow-up
Measured by the External and Internal Shame Scale for adolescents (EISS-A). Lower scores mean a better outcome
From baseline to 6-months follow-up
Changes in self-criticism
Time Frame: From baseline to 6-months follow-up
Measured by the Forms of self-criticizing/attacking and self-reassuring scale (FSCRS-A) - lower scores in self-criticising mean a better outcome
From baseline to 6-months follow-up
Changes in Psychological Inflexibility
Time Frame: From baseline to 6-months follow-up
Measured by the Avoidance and Fusion Questionnaire for Youth (AFQ-Y) - lower levels mean a better outcome
From baseline to 6-months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Coimbra

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sara Oliveira, MS, University of Coimbra

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

No

Studies a U.S. FDA-regulated device product

No

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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