Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-04-18 @ 4:50 PM
Study NCT ID:
NCT05319002
Status:
COMPLETED
Last Update Posted:
2022-04-08
First Post:
2022-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Group EMDR Intervention on Narrative Complexity and Specificity of Autobiographical Memories: the Hug the Child Study (HTC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D033262', 'term': 'Narration'}], 'ancestors': [{'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-31', 'studyFirstSubmitDate': '2022-03-22', 'studyFirstSubmitQcDate': '2022-03-31', 'lastUpdatePostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event coding - Pre-intervention', 'timeFrame': 'Event coding is measured before the 3-week group EMDR intervention', 'description': 'Event coding is measured using Manual for Coding Events in Self Defining Memories. "Relationship" nominal score means a better outcome'}, {'measure': 'Memory specificity level - Pre-intervention', 'timeFrame': 'Memory specificity level is measured before the 3-week group EMDR intervention', 'description': 'Memory specificity level is measured using Classification System and Scoring for Self-defining Autobiographical Memories. "Specific" nominal score means a better outcome'}, {'measure': 'Narrative complexity level - Pre-intervention', 'timeFrame': 'Narrative complexity level is measured before the 3-week group EMDR intervention', 'description': 'Narrative complexity level is measured using Coding System for autobiographical Memory Narratives in Psychotherapy. Higher scores mean a better outcome.'}, {'measure': 'Subjective Unit of Distress - Pre-intervention', 'timeFrame': 'Subjective Unit of Distress is measured before the 3-week group EMDR intervention', 'description': 'Subjective Unit of Distress is measured using a self-reporting scale with a 0- to 10-point rating scale. Higher scores mean a worse outcome'}, {'measure': 'Validity of Cognition - Pre-intervention', 'timeFrame': 'Validity of Cognition is measured before the 3-week group EMDR intervention', 'description': 'Validity of Cognition is measured using a self-reporting scale with a 1- to 7-point rating scale. Higher scores mean a better outcome'}, {'measure': 'Event coding - Post-intervention', 'timeFrame': 'Event coding is measured after the 3-week group EMDR intervention', 'description': 'Event coding is measured using Manual for Coding Events in Self Defining Memories. "Relationship" nominal score means a better outcome'}, {'measure': 'Memory specificity level - Post-intervention', 'timeFrame': 'Memory specificity level is measured after the 3-week group EMDR intervention', 'description': 'Memory specificity level is measured using Classification System and Scoring for Self-defining Autobiographical Memories. "Specific" nominal score means a better outcome'}, {'measure': 'Narrative complexity level - Post-intervention', 'timeFrame': 'Narrative complexity level is measured after the 3-week group EMDR intervention', 'description': 'Narrative complexity level is measured using Coding System for autobiographical Memory Narratives in Psychotherapy. Higher scores mean a better outcome.'}, {'measure': 'Subjective Unit of Distress - Post-intervention', 'timeFrame': 'Subjective Unit of Distress is measured after the 3-week group EMDR intervention', 'description': 'Subjective Unit of Distress is measured using a self-reporting scale with a 0- to 10-point rating scale. Higher scores mean a worse outcome'}, {'measure': 'Validity of Cognition - Post-intervention', 'timeFrame': 'Validity of Cognition is measured after the 3-week group EMDR intervention', 'description': 'Validity of Cognition is measured using a self-reporting scale with a 1- to 7-point rating scale. Higher scores mean a better outcome'}], 'secondaryOutcomes': [{'measure': 'Autobiographical memory definition - Pre-intervention', 'timeFrame': 'Autobiographical memory definition is measured before the 3-week group EMDR intervention', 'description': 'Autobiographical memory definition is measured using Coding System for Autobiographical Memory Narratives in Psychotherapy. "Autobiographic" nominal score means a better outcome.'}, {'measure': 'Memory integration level - Pre-intervention', 'timeFrame': 'Memory integration level is measured before the 3-week group EMDR intervention', 'description': 'Memory integration level is measured using Classification System and Scoring for Self-defining Autobiographical Memories. "Integrated" nominal score means a better outcome'}, {'measure': 'Autobiographical memory definition - Post-intervention', 'timeFrame': 'Autobiographical memory definition is measured after the 3-week group EMDR intervention', 'description': 'Autobiographical memory definition is measured using Coding System for Autobiographical Memory Narratives in Psychotherapy. "Autobiographic" nominal score means a better outcome.'}, {'measure': 'Memory integration level - Post-intervention', 'timeFrame': 'Memory integration level is measured after the 3-week group EMDR intervention', 'description': 'Memory integration level is measured using Classification System and Scoring for Self-defining Autobiographical Memories. "Integrated" nominal score means a better outcome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Child', 'EMDR', 'Narrative complexity', 'Autobiographical memories', 'Distress', 'Cognition'], 'conditions': ['Child, Only', 'Narration', 'Memory Dysfunction', 'Distress, Emotional', 'Cognitive Change']}, 'referencesModule': {'references': [{'pmid': '35805348', 'type': 'DERIVED', 'citation': 'Poli A, Gemignani A, Miccoli M. Randomized Trial on the Effects of a Group EMDR Intervention on Narrative Complexity and Specificity of Autobiographical Memories: A Path Analytic and Supervised Machine-Learning Study. Int J Environ Res Public Health. 2022 Jun 23;19(13):7684. doi: 10.3390/ijerph19137684.'}]}, 'descriptionModule': {'briefSummary': 'Background and study aims:\n\nThe Eye Movement Desensitization and Reprocessing Group Protocol with Children (EMDR-GP/C) was first developed by Korkmazlar following the Marmara earthquake in Turkey in 1999 and can be adapted for different populations. The aim of this study is to assess if a EMDR-GP program may help primary school students in improving narrative complexity and specificity of autobiographical memories, as well as their subjective unit of distress (SUD) and validity of cognition (VoC).\n\nWho can participate? Students attending the fourth or fifth year of primary school\n\nWhat does the study involve? Participants will be randomly assigned to the experimental and control groups. Participants in the experimental group will undergo a 3-week EMDR-GP with weekly 60-minute group sessions (3 sessions), while the control group will follow routine daily school activities.\n\nQuestionnaires will be used to assess narrative complexity, specificity of autobiographical memories, SUD and VoC before and after the intervention.\n\nWhat are the possible benefits and risks of participating? Benefits of participating in the study may include an improvement of narrative complexity, specificity of autobiographical memories, and their SUD and VoC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children aged 9 to 11 years\n2. Children have reasonable comprehension of spoken language and can follow simple instructions\n3. Children and their parents are willing to attend all intervention sessions\n4. Children and parents have an adequate understanding of Italian\n\nExclusion Criteria:\n\n1. Concurrent enrollment in other intervention trials\n2. Child regularly practices EMDR intervention, or other therapeutical interventions, such as cognitive behavioral therapy or meditation.'}, 'identificationModule': {'nctId': 'NCT05319002', 'acronym': 'HTC', 'briefTitle': 'Effects of a Group EMDR Intervention on Narrative Complexity and Specificity of Autobiographical Memories: the Hug the Child Study (HTC)', 'organization': {'class': 'OTHER', 'fullName': 'University of Pisa'}, 'officialTitle': 'Randomized Trial on the Effects of a Group EMDR Intervention on Narrative Complexity and Specificity of Autobiographical Memories: a Path Analytic and Supervised Machine Learning Approach', 'orgStudyIdInfo': {'id': 'HTC-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group EMDR', 'description': 'Participants in the experimental group will undergo a 3-week group EMDR intervention with weekly 60-minute group sessions.', 'interventionNames': ['Behavioral: Group EMDR']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control group will follow routine daily school activities'}], 'interventions': [{'name': 'Group EMDR', 'type': 'BEHAVIORAL', 'description': "The eight phases of the adapted group EMDR protocol was administered during each session: 1. Meeting: Explaining the nature of trauma, group rules, name tags, filling in the scales. 2. Preparation: Exploring children's support system, explaining EMDR, safe place, resource exercise, and installation with bilateral stimulation (BLS, butterfly hug or knee tapping). 3. Assessment: Drawing the worst image on a small separate sheet of paper, SUD level, (negative cognition, emotions, body sensations - if possible). 4. Desensitization: It is done with drawing on 4 separate papers with BLS (butterfly hug or knee tapping). 5. Installation: With the healing story written according to the adaptive information processing (AIP) model, the installation is accompanied BLS. 6. Body scan: A positive body state is installed with the relaxation technique. 7. Closure \\& future template: Strong closure with artwork. 8. Re-evaluation: if possible.", 'armGroupLabels': ['Group EMDR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56126', 'city': 'Pisa', 'country': 'Italy', 'facility': 'University of Pisa', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}], 'overallOfficials': [{'name': 'Andrea Poli, Psy.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pisa'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'Raw data are available on request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pisa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andrea Poli', 'investigatorAffiliation': 'University of Pisa'}}}}