Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-29 @ 3:34 AM
Study NCT ID:
NCT05149066
Status:
COMPLETED
Last Update Posted:
2021-12-08
First Post:
2021-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
#KindGirlsInACTion: A Programme for the Promotion of Mental Health of Female Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D000080103', 'term': 'Emotional Regulation'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-25', 'studyFirstSubmitDate': '2021-11-15', 'studyFirstSubmitQcDate': '2021-11-25', 'lastUpdatePostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychological Well-being', 'timeFrame': '5 months', 'description': 'Kidscreen-27'}, {'measure': 'Psychological Well-being', 'timeFrame': '3 months', 'description': 'Kidscreen-27'}, {'measure': 'Psychological Wel--being', 'timeFrame': 'Baseline', 'description': 'Kidscreen-27'}], 'secondaryOutcomes': [{'measure': 'Eating Disorders', 'timeFrame': 'Baseline', 'description': 'Eating Disorders Examination Questionnaire, EDE-Q'}, {'measure': 'Eating Disorders', 'timeFrame': '3 months', 'description': 'Eating Disorders Examination Questionnaire, EDE-Q'}, {'measure': 'Eating Disorders', 'timeFrame': '5 months', 'description': 'Eating Disorders Examination Questionnaire, EDE-Q'}, {'measure': 'Positive body image', 'timeFrame': 'Baseline', 'description': 'Body Appreciation Scale, BAS-2'}, {'measure': 'Positive body image', 'timeFrame': '3 months', 'description': 'Body Appreciation Scale, BAS-2'}, {'measure': 'Positive body image', 'timeFrame': '5 months', 'description': 'Body Appreciation Scale, BAS-2'}, {'measure': 'Social safeness', 'timeFrame': 'Baseline', 'description': 'Social Safeness and Pleasure Scale, SSPS'}, {'measure': 'Social safeness', 'timeFrame': '3 months', 'description': 'Social Safeness and Pleasure Scale, SSPS'}, {'measure': 'Social safeness', 'timeFrame': '5 months', 'description': 'Social Safeness and Pleasure Scale, SSPS'}, {'measure': 'Body image shame', 'timeFrame': 'Baseline', 'description': 'Body Image Shame Scale, BISS'}, {'measure': 'Body image shame', 'timeFrame': '3 months', 'description': 'Body Image Shame Scale, BISS'}, {'measure': 'Body image shame', 'timeFrame': '5 months', 'description': 'Body Image Shame Scale, BISS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intervention Programme', 'School-based', 'Adolescence', 'Girls', 'Psychological well-being', 'Compassion', 'Psychological flexibility', 'Positive body image'], 'conditions': ['Quality of Life', 'Eating Disorders', 'Eating Behavior', 'Psychological', 'Emotion Regulation', 'Body Image', 'Relations, Interpersonal']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being a female adolescent;\n* being aged between 12 and 18;\n* being a part of a classroome with immediate availability to attend the sessions.\n\nExclusion Criteria:\n\n* Having a clinical condition that could compromise the completion of self-report questionnaires;\n* Having a significant score on screening measures administered pre-intervention.'}, 'identificationModule': {'nctId': 'NCT05149066', 'acronym': 'KindGirlsACT', 'briefTitle': '#KindGirlsInACTion: A Programme for the Promotion of Mental Health of Female Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University of Coimbra'}, 'officialTitle': '#KindGirlsInACTion: A School-based Intervention to Promote Compassive Competences and Psychological Flexibility in Female Adolescents', 'orgStudyIdInfo': {'id': '#KindGirlsInACTion'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'The experimental group was administered a 9-sessions weekly programme in the school context.\n\nIt completed three assessment moments: pre-intervention, post-intervention and a 3-months after the intervention follow-up.', 'interventionNames': ['Behavioral: #KindGirlsInACTion']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', '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.'}], 'interventions': [{'name': '#KindGirlsInACTion', 'type': 'BEHAVIORAL', 'description': '9-session weekly cognitive-behavioural intervention to promote psychological well-being and prevent body image and eating-related disordered behaviours.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000-115', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'CINEICC', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Coimbra', 'class': 'OTHER'}, 'collaborators': [{'name': 'Joana Marta-Simões', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Integrated non-PhD member of CINEICC', 'investigatorFullName': 'Ana Laura Mendes', 'investigatorAffiliation': 'University of Coimbra'}}}}