Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT07162402
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2025-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anxiety Among Children: Adaptation and Effectiveness of the Program Super Skills for Life in School Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D066107', 'term': 'Social Skills'}, {'id': 'D000066553', 'term': 'Problem Behavior'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D002652', 'term': 'Child Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'In the intervention arm, 8 sessions Super Skills for Life (SSL), were delivered to students who were screened positive for anxiety symptoms. Whereas Wait-list control group participants were not provided with intervention, they remained as usual with routine activities by teachers.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-31', 'studyFirstSubmitDate': '2025-08-31', 'studyFirstSubmitQcDate': '2025-08-31', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Screen for Child Anxiety Related Emotional Disorders (SCARED)', 'timeFrame': 'Immediately after Intervention and Followup after 6 months', 'description': 'Psychometric tool for Anxiety Measurement'}, {'measure': 'The Center for Epidemiological Studies Depression Scale for Children (CES-DC)', 'timeFrame': 'Immediately post intervention and after 6 months', 'description': 'Psychometric Tool for the measurement of Depression'}], 'secondaryOutcomes': [{'measure': 'The Strength and Difficulties Questionnaire (SDQ)', 'timeFrame': 'Immediately post intervention and after 6 months', 'description': 'Tool for the measurement of overall emotional and behavioural problems'}, {'measure': 'Rosenberg Self-Esteem Scale (RSES)', 'timeFrame': 'Immediately after intervention and after 6 months', 'description': 'Scale for assessing Self-Esteem'}, {'measure': 'Social Skills Questionnaire (SSQ)', 'timeFrame': 'immediately after intervention and after 6 months', 'description': 'tool for assessing Social Skills'}, {'measure': 'Pediatric Quality of Life Inventory (PedsQL)', 'timeFrame': 'immediately after intervention and after 6 months', 'description': 'tool for assessing Pediatric Quality of Life'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anxiety and depressive symptoms, Pakistani Children, Super Skills for Life, Social skills, Quality of life'], 'conditions': ['Childhood Anxiety', 'Childhood Depression', 'Low Self-Esteem', 'Quality of Life (QOL)', 'Social Skills', 'Emotional Problems', 'Behavioral Problems']}, 'descriptionModule': {'briefSummary': 'Super Skills for Life (SSL) is a transdiagnostic prevention program designed for children with anxiety and depressive symptoms based on cognitive-behavioral therapy. This study is a Cluster Randomization Trial(cRCT) to determine the of the effectiveness of the SSL program to reduce anxiety and depressive symptoms along with improving self-esteem, social skills and overall quality of life in a sample of 126, 5th grade children recruited from 6 schools from Pakistan.\n\nSchools were the unit of randomization and were randomly assigned to one of two experimental conditions; intervention group (SSL) and waiting list control (WLC) group. Assessments were conducted before and after the 8 sessions of intervention and follow-up assessment after 6 months.', 'detailedDescription': 'Super Skills for Life (SSL) is a transdiagnostic prevention program designed for children with anxiety and depressive symptoms based on cognitive-behavioral therapy. This study is a Cluster Randomization Trial(cRCT) to determine the of the effectiveness of the SSL program to reduce anxiety and depressive symptoms along with improving self-esteem, social skills and overall quality of life in a sample of 126, 5th grade children recruited from 6 schools from Pakistan.\n\nSchools were the unit of randomization and were randomly assigned to one of two experimental conditions; intervention group (SSL) and waiting list control (WLC) group. Assessments were conducted before and after the 8 sessions of intervention and follow-up assessment after 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion Criteria of the study was a selection of children of Grade 5th presented with anxiety symptoms according to their scores equal to or greater than 25 on a total scale score of The Screen for Child Anxiety Related Emotional Disorders (SCARED) with age 9 and 13 years, who can speak and understand Urdu easily.\n\nExclusion Criteria:\n\n* Children who have any serious physical/medical diseases, diagnosed mental health issues, developmental delays, or learning difficulties, and are under any psychological treatment were excluded. Furthermore, children who had undergone any surgery or experienced serious traumatic events in the past 6 months and who did not get permission from their parents with written informed consent from parents/ not willing to were also excluded.'}, 'identificationModule': {'nctId': 'NCT07162402', 'briefTitle': 'Anxiety Among Children: Adaptation and Effectiveness of the Program Super Skills for Life in School Settings', 'organization': {'class': 'OTHER', 'fullName': 'Fatima Jinnah Women University'}, 'officialTitle': 'Anxiety Among Children: Adaptation and Effectiveness of the Program Super Skills for Life in School Settings', 'orgStudyIdInfo': {'id': 'FJWU/EC/2021/32'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'In the intervention arm, 8 sessions Super Skills for Life (SSL), were delivered to students who were screened positive for anxiety symptoms', 'interventionNames': ['Other: Super Skills for Life (SSL) Program']}, {'type': 'OTHER', 'label': 'Wait-List Control Group', 'description': 'Wait-list control group participants were not provided with intervention, they remained as usual with routine activities by teachers', 'interventionNames': ['Other: No Active Intervention']}], 'interventions': [{'name': 'Super Skills for Life (SSL) Program', 'type': 'OTHER', 'description': 'Its Cognitive Behaviour Therapy (CBT) Based 8 sessions Super Skills for Life (SSL) Program for childhood Anxiety Management.', 'armGroupLabels': ['Intervention Group']}, {'name': 'No Active Intervention', 'type': 'OTHER', 'description': 'Routine Activities in Class', 'armGroupLabels': ['Wait-List Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Fatima Jinnah Women University', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'will plan later after my publications'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatima Jinnah Women University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Psychologist', 'investigatorFullName': 'Nazia Mustafa', 'investigatorAffiliation': 'Fatima Jinnah Women University'}}}}