Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT06133569
Status:
RECRUITING
Last Update Posted:
2024-10-10
First Post:
2023-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ReDirection - Self Help Program for Individuals with Sexual Interest in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010378', 'term': 'Pedophilia'}], 'ancestors': [{'id': 'D010262', 'term': 'Paraphilic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Participants are allocated to either the ReDirection intervention or waitlist during the initial phase of the study and those who receive waitlist receive ReDirection during the second phase of the study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2023-10-12', 'studyFirstSubmitQcDate': '2023-11-13', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexual interest involving children', 'timeFrame': 'Pre-intervention, during the intervention, and immediately after the intervention.', 'description': 'Measured by Sexual Symptom Assessment Scale (SASS)(0-48 points; higher scores indicate more interest).'}, {'measure': 'Child sexual abuse material usage', 'timeFrame': 'Pre-intervention, during the intervention, and immediately after the intervention.', 'description': 'Measured with Sexual Child Molestation Risk Assessment (SChiMRA+), part B, item 1 (self-reported time spent last week in hours watching CSAM) including 3 follow up questions (about time/day, severity, and of youngest child).'}, {'measure': 'Other behaviors related to sexual interest in children.', 'timeFrame': 'Pre-intervention, during the intervention, and immediately after the intervention.', 'description': 'Time spent last week (hours), as self reported on the SChiMRA+ scale part B, item 4.'}, {'measure': 'Depressive symtoms', 'timeFrame': 'Pre-intervention, and immediately after the intervention.', 'description': 'Scores on the PHQ-9 questionnaire (Patient Health Questionnaire; 0-27 points; higher scores indicate more severe depressive symptoms).'}], 'secondaryOutcomes': [{'measure': 'Dynamic risk for committing child sexual abuse', 'timeFrame': 'Pre-intervention, during the intervention,and immediately after the intervention.', 'description': 'Scores on Acute-2007 (21 items; 0-42 points; higher scores indicate higher dynamic risk for committing child sexual abuse)'}, {'measure': 'Level of hypersexuality', 'timeFrame': 'Pre-intervention, and immediately after the intervention.', 'description': 'Scores on the HBI-19 questionnaire (Hypersexual Behavior Inventory; 19-95 points; higher scores indicate higher level of sexuality; more than 52 points indicate hypersexuality)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Child sexual abuse material', 'Cognitive behavioral therapy', 'Internet based self-help program', 'Individuals with sexual interest in children'], 'conditions': ['Child Abuse Sexual', 'Pedophilia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.iterapi.se/sites/bridge', 'label': 'Web page for the study'}]}, 'descriptionModule': {'briefSummary': "The overall aim of the study is to evaluate the effectiveness of the ReDirection program for individuals with low or medium risk to commit child sexual abuse.\n\nPrimary question: Is ReDirection a feasible, effective, and safe method in reducing low to medium risk participants' use of CSAM and related behaviors?", 'detailedDescription': "The present research project aims to contribute to the further development of accessible, evidence-based and safe care for people with concerns about their sexual interest regarding children, and that are using child sexual abuse material (CSAM), so that these people can access treatment according to their needs and level of risk, with the objective of reducing the risk for child sexual abuse and improving the health of the group.\n\nMore concretely, we aim to evaluate a revised version of an already available cognitive-behavioral self-help program, ReDirection, with the aim of testing whether this intervention can reduce sexual interest regarding children and CSAM use, in a group of people assessed as being at low or medium risk of committing sexual abuse of children. The intervention will be available in seven languages and will be tested in six countries.\n\nPrimary research question: Is ReDirection a feasible, effective, and safe method in reducing low to medium risk participants' use of CSAM and related behaviors?\n\nSecondary research questions: Is ReDirection effective in reducing research subjects' overall risk of committing sexual acts involving children? Does ReDirection reduce specific dynamic risk factors for committing CSA?\n\nReDirection is based on cognitive behavioral therapy and consists of five modules. The program aims to help participants reduce their CSAM use by gaining a better understanding of, and skills to manage risky sexual thoughts, feelings, and behaviors. At the end of the program, participants are offered an anonymous follow-up chat and if needed during the program, participants can contact a practitioner via chat.\n\nResearch subjects will be recruited through Darknet and Clearnet. Darknet refers to websites that are accessible via TOR or similar services. The interventions are provided by practitioners and researchers in the relevant countries.\n\nReDirection will be evaluated through an international multicenter study using randomized wait-list controlled design.\n\nThe research subjects will sign a written consent form on the Iterapi platform without disclosing personal data such as name or location. During the subsequent screening interview via chat or voice call on Iterapi, participation criteria are ensured, questions are answered, and the consent to participate is confirmed. The research subjects are thus admitted to the study.\n\nAfter inclusion, participants answer the baseline survey which consists of validated self-assessment questionnaires with both multiple choice and free-text answers.\n\nWeekly during, after the waitlist, and after the therapeutic intervention, research subjects answer questions to evaluate the effectiveness and safety of the interventions.\n\nA Statistical Analysis Plan (SAP) based on pilot study is pre-registered at the OSF platform. The SAP describes sample size calculations, and planned analyses of outcome measures."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sufficient language skills: English, Swedish, Finnish, Czech, Slovak, German, or Spanish\n* concern about sexual interest regarding children\\*,\n* CSAM use past six month\n* Low to medium risk for committing child sexual abuse according to the SChiMRA scale\n\nExclusion Criteria:\n\n\\- Participants with a severe psychiatric illness (such as high acute suicide risk or severe substance abuse) will be excluded, or lack of serious intentions to participate.'}, 'identificationModule': {'nctId': 'NCT06133569', 'acronym': 'ReDirection', 'briefTitle': 'ReDirection - Self Help Program for Individuals with Sexual Interest in Children', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'A Multicenter, Waitlist Controlled, Randomized Clinical Trial of the Effectiveness of a Self Help Program Based on Cognitive Behavioral Therapy for Individuals with Sexual Interest in Children.', 'orgStudyIdInfo': {'id': '2023-02321-01'}, 'secondaryIdInfos': [{'id': '101084355-BRIDGE-ISF-2021', 'type': 'OTHER', 'domain': 'European Commission'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ReDirection', 'description': 'ReDirection is a self help program based on cognitive behavioral therapy methodology and consists of five modules. The program aims to help participants reduce their CSAM use by gaining a better understanding of, and skills to manage risky sexual thoughts, feelings, and behaviors.', 'interventionNames': ['Behavioral: ReDirection']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist', 'description': 'Participants are on a waitlist which means they have no active intervention, only weekly measurements with the same questionnaires as in the active arm.'}], 'interventions': [{'name': 'ReDirection', 'type': 'BEHAVIORAL', 'description': 'Self help program based on principles for cognitive behavioral therapy', 'armGroupLabels': ['ReDirection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Klecany', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Katerina Klapilova, Ass Professor', 'role': 'CONTACT'}], 'facility': 'National Institute of Mental Health', 'geoPoint': {'lat': 50.17599, 'lon': 14.41148}}, {'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Nina Vaarhanen-Valkonen', 'role': 'CONTACT'}], 'facility': 'Protect Children NGO', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Peer Briken, Professor', 'role': 'CONTACT'}], 'facility': '[University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Bratislava', 'status': 'RECRUITING', 'country': 'Slovakia', 'contacts': [{'name': 'Josef Metenko, Professor', 'role': 'CONTACT'}], 'facility': 'Bratislava Police Academy', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'city': 'Castelló', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rafael Ballester, Professor', 'role': 'CONTACT'}], 'facility': 'Universitat Jaume I', 'geoPoint': {'lat': 41.01149, 'lon': 0.84856}}, {'zip': '11842', 'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Christoffer Rahm, MD PhD', 'role': 'CONTACT', 'email': 'christoffer.rahm@ki.se', 'phone': '+46793393723'}, {'name': 'Christoffer Rahm, MD PhD', 'role': 'CONTACT'}], 'facility': 'Centre for psychiatry research, Region Stockholm', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Christoffer Rahm, MD, PhD', 'role': 'CONTACT', 'email': 'christoffer.rahm@ki.se', 'phone': '+46793393723'}, {'name': 'Maria Breide', 'role': 'CONTACT', 'email': 'maria.breide@ki.se', 'phone': '+46735563825'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre for Psychiatry Research, Region Stockholm, Sweden', 'class': 'UNKNOWN'}, {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, {'name': 'Universitat Jaume I, Spain', 'class': 'UNKNOWN'}, {'name': 'Protect Children Organisation, Finland', 'class': 'UNKNOWN'}, {'name': 'National Institute of Mental Health, Czech Republic', 'class': 'OTHER'}, {'name': 'Academy of the Police Force, Bratislava, Slovakia', 'class': 'UNKNOWN'}, {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christoffer Rahm', 'investigatorAffiliation': 'Karolinska Institutet'}}}}