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#KindGirlsInACTion: A Programme for the Promotion of Mental Health of Female Adolescents (KindGirlsACT)

Primary Purpose

Quality of Life, Eating Disorders, Eating Behavior

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
#KindGirlsInACTion
Sponsored by
University of Coimbra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Quality of Life focused on measuring Intervention Programme, School-based, Adolescence, Girls, Psychological well-being, Compassion, Psychological flexibility, Positive body image

Eligibility Criteria

12 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • CINEICC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Psychological Well-being
Kidscreen-27
Psychological Well-being
Kidscreen-27
Psychological Wel--being
Kidscreen-27

Secondary Outcome Measures

Eating Disorders
Eating Disorders Examination Questionnaire, EDE-Q
Eating Disorders
Eating Disorders Examination Questionnaire, EDE-Q
Eating Disorders
Eating Disorders Examination Questionnaire, EDE-Q
Positive body image
Body Appreciation Scale, BAS-2
Positive body image
Body Appreciation Scale, BAS-2
Positive body image
Body Appreciation Scale, BAS-2
Social safeness
Social Safeness and Pleasure Scale, SSPS
Social safeness
Social Safeness and Pleasure Scale, SSPS
Social safeness
Social Safeness and Pleasure Scale, SSPS
Body image shame
Body Image Shame Scale, BISS
Body image shame
Body Image Shame Scale, BISS
Body image shame
Body Image Shame Scale, BISS

Full Information

First Posted
November 15, 2021
Last Updated
November 25, 2021
Sponsor
University of Coimbra
Collaborators
Joana Marta-Simões
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1. Study Identification

Unique Protocol Identification Number
NCT05149066
Brief Title
#KindGirlsInACTion: A Programme for the Promotion of Mental Health of Female Adolescents
Acronym
KindGirlsACT
Official Title
#KindGirlsInACTion: A School-based Intervention to Promote Compassive Competences and Psychological Flexibility in Female Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Coimbra
Collaborators
Joana Marta-Simões

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Eating Disorders, Eating Behavior, Psychological, Emotion Regulation, Body Image, Relations, Interpersonal
Keywords
Intervention Programme, School-based, Adolescence, Girls, Psychological well-being, Compassion, Psychological flexibility, Positive body image

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
#KindGirlsInACTion
Intervention Description
9-session weekly cognitive-behavioural intervention to promote psychological well-being and prevent body image and eating-related disordered behaviours.
Primary Outcome Measure Information:
Title
Psychological Well-being
Description
Kidscreen-27
Time Frame
5 months
Title
Psychological Well-being
Description
Kidscreen-27
Time Frame
3 months
Title
Psychological Wel--being
Description
Kidscreen-27
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Eating Disorders
Description
Eating Disorders Examination Questionnaire, EDE-Q
Time Frame
Baseline
Title
Eating Disorders
Description
Eating Disorders Examination Questionnaire, EDE-Q
Time Frame
3 months
Title
Eating Disorders
Description
Eating Disorders Examination Questionnaire, EDE-Q
Time Frame
5 months
Title
Positive body image
Description
Body Appreciation Scale, BAS-2
Time Frame
Baseline
Title
Positive body image
Description
Body Appreciation Scale, BAS-2
Time Frame
3 months
Title
Positive body image
Description
Body Appreciation Scale, BAS-2
Time Frame
5 months
Title
Social safeness
Description
Social Safeness and Pleasure Scale, SSPS
Time Frame
Baseline
Title
Social safeness
Description
Social Safeness and Pleasure Scale, SSPS
Time Frame
3 months
Title
Social safeness
Description
Social Safeness and Pleasure Scale, SSPS
Time Frame
5 months
Title
Body image shame
Description
Body Image Shame Scale, BISS
Time Frame
Baseline
Title
Body image shame
Description
Body Image Shame Scale, BISS
Time Frame
3 months
Title
Body image shame
Description
Body Image Shame Scale, BISS
Time Frame
5 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: being a female adolescent; being aged between 12 and 18; being a part of a classroome with immediate availability to attend the sessions. Exclusion Criteria: Having a clinical condition that could compromise the completion of self-report questionnaires; Having a significant score on screening measures administered pre-intervention.
Facility Information:
Facility Name
CINEICC
City
Coimbra
ZIP/Postal Code
3000-115
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

#KindGirlsInACTion: A Programme for the Promotion of Mental Health of Female Adolescents

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