Ignite Creation Date:
2025-12-24 @ 1:01 PM
Ignite Modification Date:
2025-12-27 @ 9:13 PM
Study NCT ID:
NCT01483261
Status:
COMPLETED
Last Update Posted:
2011-12-02
First Post:
2011-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An RCT of Trauma Focused-Cognitive Behavioral Therapy With Sexually Exploited, War-affected Girls in the DRC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-01', 'studyFirstSubmitDate': '2011-11-29', 'studyFirstSubmitQcDate': '2011-11-29', 'lastUpdatePostDateStruct': {'date': '2011-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index', 'timeFrame': 'baseline, post-intervention and 3-months'}], 'secondaryOutcomes': [{'measure': 'Change in Psychosocial Distress as measured by the African Youth Psychosocial Assessment Instrument', 'timeFrame': 'baseline post-intervention and 3-months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Trauma-Focused Cognitive Behavior Therapy', 'Sexually Exploited Girls', 'Post-traumatic Stress Symptoms', 'Psychosocial Distress'], 'conditions': ['Post-traumatic Stress Symptoms', 'Psychosocial Distress']}, 'referencesModule': {'references': [{'pmid': '23582867', 'type': 'DERIVED', 'citation': "O'Callaghan P, McMullen J, Shannon C, Rafferty H, Black A. A randomized controlled trial of trauma-focused cognitive behavioral therapy for sexually exploited, war-affected Congolese girls. J Am Acad Child Adolesc Psychiatry. 2013 Apr;52(4):359-69. doi: 10.1016/j.jaac.2013.01.013. Epub 2013 Mar 6."}]}, 'descriptionModule': {'briefSummary': 'To date, no RCT has examined the efficacy of Trauma-Focused Cognitive Behavioral Therapy with Sexually Exploited, War Affected Adolescent Girls in the Democratic Republic of Congo. This study seeks to fill this gap by designing, implementing and testing such an intervention using both an intervention and waiting list control group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Suicidal ideation (irrespective of score on any other measure)\n\nExclusion Criteria:\n\n* psychosis\n* mental retardation\n* inability to understand Swahili\n* one standard deviation below the mean on every measure'}, 'identificationModule': {'nctId': 'NCT01483261', 'briefTitle': 'An RCT of Trauma Focused-Cognitive Behavioral Therapy With Sexually Exploited, War-affected Girls in the DRC', 'organization': {'class': 'OTHER', 'fullName': "Queen's University, Belfast"}, 'officialTitle': 'Is Trauma-Focused Cognitive Behavioral Therapy Effective in Reducing Post-traumatic Stress and Psychosocial Distress Among Sexually Exploited, War-affected Girls in the Democratic Republic of Congo.', 'orgStudyIdInfo': {'id': 'PREC23-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trauma-Focused Cognitive Behavioral Therapy', 'interventionNames': ['Behavioral: Trauma-Focused Cognitive Behavioral Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting List Control'}], 'interventions': [{'name': 'Trauma-Focused Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': '15 sessions of manualised, culturally modified trauma-focused cognitive behavior therapy', 'armGroupLabels': ['Trauma-Focused Cognitive Behavioral Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beni', 'state': 'South Kivu', 'country': 'Republic of the Congo', 'facility': 'World Vision Rebound Centre'}], 'overallOfficials': [{'name': 'Dr Ciaran Shannon, BA, MA, DClin', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chartered Clinical Psychologist (British Psychological Society)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University, Belfast", 'class': 'OTHER'}, 'collaborators': [{'name': 'World Vision', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Doctoral Student in Educational, Child and Adolescent Psychology in Queen's University Belfast", 'investigatorFullName': "Paul O'Callaghan", 'investigatorAffiliation': "Queen's University, Belfast"}}}}