- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05149066
#KindGirlsInACTion: A Programme for the Promotion of Mental Health of Female Adolescents (KindGirlsACT)
November 25, 2021 updated by: Ana Laura Mendes, University of Coimbra
#KindGirlsInACTion: A School-based Intervention to Promote Compassive Competences and Psychological Flexibility in Female Adolescents
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- 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
-
-
-
Coimbra, Portugal, 3000-115
- CINEICC
-
-
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
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
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: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
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. |
9-session weekly cognitive-behavioural intervention to promote psychological well-being and prevent body image and eating-related disordered behaviours.
|
No Intervention: Control group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychological Well-being
Time Frame: 5 months
|
Kidscreen-27
|
5 months
|
Psychological Well-being
Time Frame: 3 months
|
Kidscreen-27
|
3 months
|
Psychological Wel--being
Time Frame: Baseline
|
Kidscreen-27
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eating Disorders
Time Frame: Baseline
|
Eating Disorders Examination Questionnaire, EDE-Q
|
Baseline
|
Eating Disorders
Time Frame: 3 months
|
Eating Disorders Examination Questionnaire, EDE-Q
|
3 months
|
Eating Disorders
Time Frame: 5 months
|
Eating Disorders Examination Questionnaire, EDE-Q
|
5 months
|
Positive body image
Time Frame: Baseline
|
Body Appreciation Scale, BAS-2
|
Baseline
|
Positive body image
Time Frame: 3 months
|
Body Appreciation Scale, BAS-2
|
3 months
|
Positive body image
Time Frame: 5 months
|
Body Appreciation Scale, BAS-2
|
5 months
|
Social safeness
Time Frame: Baseline
|
Social Safeness and Pleasure Scale, SSPS
|
Baseline
|
Social safeness
Time Frame: 3 months
|
Social Safeness and Pleasure Scale, SSPS
|
3 months
|
Social safeness
Time Frame: 5 months
|
Social Safeness and Pleasure Scale, SSPS
|
5 months
|
Body image shame
Time Frame: Baseline
|
Body Image Shame Scale, BISS
|
Baseline
|
Body image shame
Time Frame: 3 months
|
Body Image Shame Scale, BISS
|
3 months
|
Body image shame
Time Frame: 5 months
|
Body Image Shame Scale, BISS
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
September 1, 2017
Primary Completion (Actual)
February 28, 2020
Study Completion (Actual)
September 1, 2021
Study Registration Dates
First Submitted
November 15, 2021
First Submitted That Met QC Criteria
November 25, 2021
First Posted (Actual)
December 8, 2021
Study Record Updates
Last Update Posted (Actual)
December 8, 2021
Last Update Submitted That Met QC Criteria
November 25, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #KindGirlsInACTion
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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