NCT04850872

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

4.5 years

First QC Date

April 14, 2021

Last Update Submit

March 19, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    From baseline to 6-months follow-up

Secondary Outcomes (5)

  • Changes in Mindfulness

    From baseline to 6-months follow-up

  • Changes in Psychological Inflexibility

    From baseline to 6-months follow-up

  • Changes in Self-compassion

    From baseline to 6-months follow-up

  • Changes in shame

    From baseline to 6-months follow-up

  • Changes in self-criticism

    From baseline to 6-months follow-up

Study Arms (2)

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

Control

NO INTERVENTION

Participants of control group do not receive the intervention Programme (PLAYwithHEART), nor any other program, and only complete self-report measures.

Interventions

PLAYwithHEART programme for adolescent athletes is an intervention programme based on Mindfulness, Acceptance, and Compassion for adolescent athletes

Experimental

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Different sports clubs in Portugal

Coimbra, Portugal

Location

Study Officials

  • Sara Oliveira, MS

    University of Coimbra

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MS

Study Record Dates

First Submitted

April 14, 2021

First Posted

April 20, 2021

Study Start

February 1, 2020

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

March 21, 2024

Record last verified: 2024-03

Locations