Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2026-02-21 @ 9:48 PM
Study NCT ID:
NCT01612104
Status:
COMPLETED
Last Update Posted:
2015-12-07
First Post:
2012-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychological First Aid With Children in a High Risk Group - a Repeated Single Case Design
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D000275', 'term': 'Adjustment Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088782', 'term': 'Psychological First Aid'}], 'ancestors': [{'id': 'D004637', 'term': 'Emergency Services, Psychiatric'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-04', 'studyFirstSubmitDate': '2012-05-31', 'studyFirstSubmitQcDate': '2012-06-04', 'lastUpdatePostDateStruct': {'date': '2015-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Children's Revised Impact of Event Scale (CRIES)", 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'Child Post-Traumatic Cognition Inventory (CPTCI)', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Post Traumatic Stress Disorder', 'Anxiety symptoms', 'Depressive symptoms', 'Externalizing behavior', 'Reduced quality of life'], 'conditions': ['Post Traumatic Stress Disorder', 'Adjustment Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot-study is to evaluate a cognitive behavioral method "Psychological First Aid" used with a group of children (11-16 years) in high risk of developing psychological problems. Participants are recruited from a low-threshold program ("The Children\'s House in Oslo") where counseling is given to children suspected of being physically or sexually abused, or having witnessed domestic violence. The study includes twelve children and teenagers that receive 2 to 6 sessions of counseling. Psychological problems (e.g. anxiety, depression, reactions to trauma) and quality of life will be assessed at pre- post and follow-up (after 3, 6 and 12 months). In addition, some symptoms of will be assessed daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children/adolescents that:\n\n * contact "The Children\'s House in Oslo" after having experienced potential traumatic event(s).\n * are assessed as having psychological symptoms related to potential trauma\n * are between 11 and 16 years old\n * agree to participate in the study (both the youth and his/her parents(s)\n* understand and speak Norwegian\n\nExclusion Criteria:\n\n\\- Children/adolescents with:\n\n* mental retardation\n* reading skills below 8 year\n* psychosis\n* high risk of suicidal behavior is assumed'}, 'identificationModule': {'nctId': 'NCT01612104', 'briefTitle': 'Psychological First Aid With Children in a High Risk Group - a Repeated Single Case Design', 'organization': {'class': 'OTHER', 'fullName': 'NORCE Norwegian Research Centre AS'}, 'officialTitle': 'Psychological First Aid With Children in a High Risk Group - a Repeated Single Case Design', 'orgStudyIdInfo': {'id': 'RKBU62'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psychological First Aid', 'description': 'Psychological material developed for children and adolescents, based on cognitive behavioral theory, used to structure therapeutic conversations and/or for self-help.', 'interventionNames': ['Behavioral: Psychological First Aid']}], 'interventions': [{'name': 'Psychological First Aid', 'type': 'BEHAVIORAL', 'description': 'A cognitive behavioral (CBT) method structuring and focusing psychological therapy sessions with children and adolescents having been exposed to potential trauma', 'armGroupLabels': ['Psychological First Aid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': "The Children's House in Oslo", 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Bente SM Haugland, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Child and Adolescent Mental Health, Western Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NORCE Norwegian Research Centre AS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}