Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2026-03-03 @ 4:09 AM
Study NCT ID:
NCT00552006
Status:
COMPLETED
Last Update Posted:
2011-03-08
First Post:
2007-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Formerly Abducted Children (FAC) in Uganda
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-07', 'studyFirstSubmitDate': '2007-10-31', 'studyFirstSubmitQcDate': '2007-10-31', 'lastUpdatePostDateStruct': {'date': '2011-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Load of traumatic symptoms measured via the CAPS (Clinician-administered PTSD scale)', 'timeFrame': '3 months, 6 months and 1 year after completion of treatment'}], 'secondaryOutcomes': [{'measure': 'Load of depressive symptoms measured via the MINI, strength of suicidal ideation measured via the MINI, functionality measured via the CAPS, feelings of guilt measured via the CAPS, stigmatization measured via an adapted version of the PSQ', 'timeFrame': '3 months, 6 months and 1 year after completion of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PTSD', 'Treatment', 'Randomized Controlled Clinical Trial', 'Combat', 'Child Soldiers', 'Dissemination', 'Narrative Exposure Therapy', 'Africa'], 'conditions': ['Stress Disorders, Post-Traumatic']}, 'referencesModule': {'references': [{'pmid': '21813428', 'type': 'DERIVED', 'citation': 'Ertl V, Pfeiffer A, Schauer E, Elbert T, Neuner F. Community-implemented trauma therapy for former child soldiers in Northern Uganda: a randomized controlled trial. JAMA. 2011 Aug 3;306(5):503-12. doi: 10.1001/jama.2011.1060.'}]}, 'descriptionModule': {'briefSummary': 'In the aftermath of traumatic experiences like natural disasters or man-caused traumatic events, such as war experiences, a substantial part of the affected individuals develop a number of psychological symptoms. The characteristic symptom pattern occurring in the aftermath of traumatic events is called posttraumatic stress disorder (PTSD) and includes functional impairment of the affected individuals. The investigators want to test whether Narrative Exposure Therapy (NET) is an effective tool in reducing trauma related symptoms in formerly abducted children and youths and former child soldiers, when applied by lay personnel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of PTSD (Post-Traumatic Stress Disorder) derived from expert interviews\n* member of the group of formerly abducted people or former child soldiers\n\nExclusion Criteria:\n\n* current substance dependence\n* mental retardation\n* psychotic disorder'}, 'identificationModule': {'nctId': 'NCT00552006', 'briefTitle': 'Treatment of Formerly Abducted Children (FAC) in Uganda', 'organization': {'class': 'OTHER', 'fullName': 'University of Konstanz'}, 'officialTitle': 'A Randomized Controlled Clinical Trial (RCCT) to Test the Effectiveness of Narrative Exposure Therapy (NET) Versus an Attention Control Condition (AC) in Reducing Trauma Related Symptoms in Formerly Abducted Children and Former Child Soldiers Suffering From Posttraumatic Stress Disorder (PTSD)', 'orgStudyIdInfo': {'id': 'NE 1390/2-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NET', 'interventionNames': ['Behavioral: Narrative Exposure Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AC', 'interventionNames': ['Behavioral: Academic Counseling']}, {'type': 'NO_INTERVENTION', 'label': 'WL', 'description': 'Waiting list'}], 'interventions': [{'name': 'Narrative Exposure Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['NET'], 'description': 'Narrative Exposure Therapy (NET) is based on Testimony Therapy in combination with cognitive behavioural exposure techniques and elements of client-centered counselling. In cooperation with the therapist the clients can restore their autobiographic memories about their traumatic experiences. In this way fragmentary memories are transformed into a coherent narrative structure. This practice enables the processing of painful emotions and the construction of clear contingencies of dangerous and safe conditions, generally leading to significant emotional recovery. Therapeutic aims are the reduction of PTSD-Symptomload via activation of fear-network and habituation of fear and the placement of traumatic experiences in a reconstructed, detailed and consistent autobiography.\n\nNET will be applied in eight sessions (90-120min/session) in a standardized, manualized manner.', 'armGroupLabels': ['NET']}, {'name': 'Academic Counseling', 'type': 'BEHAVIORAL', 'otherNames': ['AC'], 'description': 'Missing time in educational life is one major issue for formerly abducted people. The Academic Counseling (AC) intervention is an active Control condition and improves English skills and works at the same time on concentration, learning and memory abilities. The clients will gain some of the abilities and skills they might have lost or developed weaknesses in due to their abduction.\n\nAC will be applied in eight sessions (90-120min/session) in a standardized, manualized manner.', 'armGroupLabels': ['AC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anaka', 'state': 'Amuru', 'country': 'Uganda', 'facility': 'Vivo Counselling Centre', 'geoPoint': {'lat': 2.60114, 'lon': 31.94749}}], 'overallOfficials': [{'name': 'Frank Neuner, Univ.-Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bielefeld University'}, {'name': 'Thomas Elbert, Univ.-Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Konstanz'}, {'name': 'Verena Ertl, Dipl.-Psych. (MSc)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bielefeld University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Konstanz', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Prof.Dr. Frank Neuner', 'oldOrganization': 'Bielefeld University'}}}}