NCT05149066

Brief Summary

The #KindGirlsInACTion project started in 2017 and developed and implemented a psychotherapeutic intervention program in Portuguese female adolescents. This program aimed to improve the overall quality of life and well-being of the participants, and specifically to promote a qualitative improvement in body image and interpersonal relationships, through the promotion of self-compassion, compassion and psychological flexibility. #KindGirlsInACTion is a school-based program, with 9 sessions over 9 weeks. It is essentially practical and interactive, with exercises created specifically for the program, as well as the regular practice of mindfulness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable quality-of-life

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
Last Updated

December 8, 2021

Status Verified

November 1, 2021

Enrollment Period

2.5 years

First QC Date

November 15, 2021

Last Update Submit

November 25, 2021

Conditions

Keywords

Intervention ProgrammeSchool-basedAdolescenceGirlsPsychological well-beingCompassionPsychological flexibilityPositive body image

Outcome Measures

Primary Outcomes (3)

  • Psychological Well-being

    Kidscreen-27

    5 months

  • Psychological Well-being

    Kidscreen-27

    3 months

  • Psychological Wel--being

    Kidscreen-27

    Baseline

Secondary Outcomes (12)

  • Eating Disorders

    Baseline

  • Eating Disorders

    3 months

  • Eating Disorders

    5 months

  • Positive body image

    Baseline

  • Positive body image

    3 months

  • +7 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group was administered a 9-sessions weekly programme in the school context. It completed three assessment moments: pre-intervention, post-intervention and a 3-months after the intervention follow-up.

Behavioral: #KindGirlsInACTion

Control group

NO INTERVENTION

The control group did not receive any intervention. It completed three assessment moments: pre-intervention, post-intervention and a 3-months after the intervention follow-up.

Interventions

9-session weekly cognitive-behavioural intervention to promote psychological well-being and prevent body image and eating-related disordered behaviours.

Experimental group

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • being a female adolescent;
  • being aged between 12 and 18;
  • being a part of a classroome with immediate availability to attend the sessions.

You may not qualify if:

  • Having a clinical condition that could compromise the completion of self-report questionnaires;
  • Having a significant score on screening measures administered pre-intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CINEICC

Coimbra, 3000-115, Portugal

Location

MeSH Terms

Conditions

Feeding and Eating DisordersFeeding BehaviorEmotional RegulationPsychological Well-Being

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavior, AnimalBehaviorSelf-ControlSocial BehaviorPersonal Satisfaction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Integrated non-PhD member of CINEICC

Study Record Dates

First Submitted

November 15, 2021

First Posted

December 8, 2021

Study Start

September 1, 2017

Primary Completion

February 28, 2020

Study Completion

September 1, 2021

Last Updated

December 8, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations