Quality of LifeKindGirlsACTNCT05149066
#KindGirlsInACTion: A Programme for the Promotion of Mental Health of Female Adolescents
A study testing #KindGirlsInACTion in people with Quality of Life and Eating Disorders, run by University of Coimbra at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Eating Disorders, Eating Behavior
- What is being tested?
- #KindGirlsInACTion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2017to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- being a female adolescent;
- being aged between 12 and 18;
- being a part of a classroome with immediate availability to attend the sessions.
Who cannot join
- Having a clinical condition that could compromise the completion of self-report questionnaires;
- Having a significant score on screening measures administered pre-intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: #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.
- Conditions
- Quality of Life, Eating Disorders, Eating Behavior, Psychological, Emotion Regulation, Body Image
- Being tested
- #KindGirlsInACTion
- Keywords
- Intervention Programme, School-based, Adolescence, Girls, Psychological well-being, Compassion, Psychological flexibility, Positive body image
- Medical subject headings
- Feeding and Eating Disorders, Feeding Behavior, Emotional Regulation, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
#KindGirlsInACTionBehavioural
9-session weekly cognitive-behavioural intervention to promote psychological well-being and prevent body image and eating-related disordered behaviours.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Well-being
Kidscreen-27
Measured: 5 months
Psychological Well-being
Kidscreen-27
Measured: 3 months
Psychological Wel--being
Kidscreen-27
Measured: Baseline
Secondary outcomes (12)
Eating Disorders
Eating Disorders Examination Questionnaire, EDE-Q
Measured: Baseline
Eating Disorders
Eating Disorders Examination Questionnaire, EDE-Q
Measured: 3 months
Eating Disorders
Eating Disorders Examination Questionnaire, EDE-Q
Measured: 5 months
Positive body image
Body Appreciation Scale, BAS-2
Measured: Baseline
Positive body image
Body Appreciation Scale, BAS-2
Measured: 3 months
Positive body image
Body Appreciation Scale, BAS-2
Measured: 5 months
Social safeness
Social Safeness and Pleasure Scale, SSPS
Measured: Baseline
Social safeness
Social Safeness and Pleasure Scale, SSPS
Measured: 3 months
Social safeness
Social Safeness and Pleasure Scale, SSPS
Measured: 5 months
Body image shame
Body Image Shame Scale, BISS
Measured: Baseline
Body image shame
Body Image Shame Scale, BISS
Measured: 3 months
Body image shame
Body Image Shame Scale, BISS
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Sep 2017
- Primary completion28 Feb 2020
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Joana Marta-Simões
- Responsible party
- Principal investigator, Ana Laura Mendes, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149066
- Sponsor's protocol ID
- #KindGirlsInACTion
- Acronym
- KindGirlsACT
- Status last verified
- Nov 2021
- First submitted
- 15 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- #KindGirlsInACTion: A School-based Intervention to Promote Compassive Competences and Psychological Flexibility in Female Adolescents
- ClinicalTrials.gov ID
- NCT05149066
- Acronym / sponsor ID
- KindGirlsACT / #KindGirlsInACTion
- Conditions
- Quality of Life, Eating Disorders, Eating Behavior, Psychological, Emotion Regulation, Body Image
- Keywords
- Intervention Programme, School-based, Adolescence, Girls, Psychological well-being, Compassion, Psychological flexibility, Positive body image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- Joana Marta-Simões
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: #KindGirlsInACTionThe 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. |
| 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- being a female adolescent;
- being aged between 12 and 18;
- being a part of a classroome with immediate availability to attend the sessions.
Key exclusion criteria (2 listed)
- Having a clinical condition that could compromise the completion of self-report questionnaires;
- Having a significant score on screening measures administered pre-intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| #KindGirlsInACTion9-session weekly cognitive-behavioural intervention to promote psychological well-being and prevent body image and eating-related disordered behaviours. | Behavioural | Experimental group |
Primary outcome
Psychological Well-being
Time frame: 5 months
Kidscreen-27
Psychological Well-being
Time frame: 3 months
Kidscreen-27
Psychological Wel--being
Time frame: Baseline
Kidscreen-27
12 secondary outcomes
Eating Disorders
Time frame: Baseline
Eating Disorders
Time frame: 3 months
Eating Disorders
Time frame: 5 months
Positive body image
Time frame: Baseline
Positive body image
Time frame: 3 months
Positive body image
Time frame: 5 months
Social safeness
Time frame: Baseline
Social safeness
Time frame: 3 months
Social safeness
Time frame: 5 months
Body image shame
Time frame: Baseline
Body image shame
Time frame: 3 months
Body image shame
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing #KindGirlsInACTion in people with Quality of Life and Eating Disorders, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Well-being (time frame: 5 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.