Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-03 @ 9:27 AM
Study NCT ID:
NCT02181751
Status:
WITHDRAWN
Last Update Posted:
2022-12-01
First Post:
2014-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 1-year Program to Treat Children Who Have Been Victims of Child Sexual Abuse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Study was never initiated', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2014-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-28', 'studyFirstSubmitDate': '2014-07-02', 'studyFirstSubmitQcDate': '2014-07-02', 'lastUpdatePostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post Traumatic Stress Disorder Symptom Severity', 'timeFrame': '4 Months', 'description': 'PTSD symptom severity will be measured using the Child Post-Traumatic Stress Disorder Symptom Scale (CPSS)'}], 'secondaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': '4 Months', 'description': 'Quality of Life will be measured using the KidKindl, a 24 item self-report questionnaire.'}, {'measure': 'Depression and Anxiety', 'timeFrame': '4 Months', 'description': "Depression and Anxiety will be measured using the Revised Children's Anxiety and Depression Scale (RCADS-Short Version)"}, {'measure': 'Level of Attachment', 'timeFrame': '4 Months', 'description': 'Level of Attachment will be measured using 5 secure attachment questions on a Likert scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Child Sexual Abuse', 'CSA', 'Treatment', 'Prevention', 'PTSD', 'Post Traumatic Stress Disorder', 'Depression', 'Anxiety', 'Quality of Life', 'Attachment', 'Cognitive Behavioural Therapy', 'Group Therapy'], 'conditions': ['Sexual Abuse of Child (If Focus of Attention is on Victim)']}, 'descriptionModule': {'briefSummary': 'Our goal in this study is examine if a program designed to decrease the severity of Post-Traumatic Stress Disorder symptoms in sexually abused children between the ages of 8-12 was effective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of sexual abuse\n* Aged 8 - 12 years\n* Developmentally able to be on-site in a "camp-like" treatment facility for 3 weeks with their parent/guardian (or without if family is not available to join the child at the Be Brave Ranch)\n* Able to perform skills of daily living for self care\n* Good physical health\n\nExclusion Criteria:\n\n* Severe mental health issues including (but not limited to):\n* Recent suicide attempt\n* History of psychosis\n* History of significant self-harm\n* History of homicidal thoughts or actions\n* History of violent behaviours sufficient to be considered a threat to others\n* Acute eating disorder.\n* Significant risk of absconding, or history of absconding\n* Serious behavioural problems\n* Significant use of drugs or alcohol\n* History of sexual violence or sexual behaviour towards others\n* Any significant interaction with the justice system or police\n* Cognitive impairment that would interfere with treatment benefits\n* Medical conditions that are not stable\n* Severe medical conditions'}, 'identificationModule': {'nctId': 'NCT02181751', 'briefTitle': 'A 1-year Program to Treat Children Who Have Been Victims of Child Sexual Abuse', 'organization': {'class': 'OTHER', 'fullName': 'Little Warriors'}, 'officialTitle': 'A 1-year Program to Treat Children Who Have Been Victims of Child Sexual Abuse', 'orgStudyIdInfo': {'id': 'LW2014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment Group', 'description': 'Children in the Treatment Group will receive treatment for a Trauma Focused Cognitive Behavioural Therapy Group.', 'interventionNames': ['Other: Trauma Focused Cognitive Behavioural Therapy Group']}], 'interventions': [{'name': 'Trauma Focused Cognitive Behavioural Therapy Group', 'type': 'OTHER', 'description': 'Youth may participate in trauma focused cognitive behavioural group therapy (TF-CBT)', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ardrossan', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Be Brave Ranch', 'geoPoint': {'lat': 53.55014, 'lon': -113.13529}}], 'overallOfficials': [{'name': 'Farrel Greenspan, MC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Little Warriors', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}