Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-30 @ 2:15 AM
Study NCT ID:
NCT04235335
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2020-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healing Circles: An Intervention for Canadian Indigenous Mothers & Children Affected by IPV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2020-01-16', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal Depression', 'timeFrame': 'Measured immediately post-intervention', 'description': 'Centers for Epidemiological Studies-Depression (CES-D)'}, {'measure': 'Maternal Depression', 'timeFrame': 'Measured 6-8 months post-intervention', 'description': 'Centers for Epidemiological Studies-Depression (CES-D)'}, {'measure': 'Child Depression', 'timeFrame': 'Measured Immediately post-intervention', 'description': 'Child Depression Inventory (CDI)'}, {'measure': 'Child Depression', 'timeFrame': 'Measured 6-8 months post-intervention', 'description': 'Child Depression Inventory (CDI)'}, {'measure': 'Maternal Anxiety', 'timeFrame': 'Measured Immediately post-intervention', 'description': 'Beck Anxiety Scale'}, {'measure': 'Maternal Anxiety', 'timeFrame': 'Measured 6-8 months post-intervention', 'description': 'Beck Anxiety Scale'}, {'measure': 'Child Anxiety', 'timeFrame': 'Measured immediately post-intervention', 'description': "Revised Children's Manifest Anxiety Scale - 2nd Edition Short Form (RCMAS-2)"}, {'measure': 'Child Anxiety', 'timeFrame': 'Measured 6-8 months post-intervention', 'description': "Revised Children's Manifest Anxiety Scale - 2nd Edition Short Form (RCMAS-2)"}, {'measure': 'Maternal trauma symptoms', 'timeFrame': 'Measured immediately post-intervention', 'description': 'PTSD Checklist (PCL-5)'}, {'measure': 'Maternal trauma symptoms', 'timeFrame': 'Measured 6-8 months post-intervention', 'description': 'PTSD Checklist (PCL-5)'}, {'measure': 'Child trauma symptoms', 'timeFrame': 'Measured immediately post-intervention', 'description': 'University of California - Los Angeles (UCLA) Reaction Index'}, {'measure': 'Child trauma symptoms', 'timeFrame': 'Measured 6-8 months post-intervention', 'description': 'University of California - Los Angeles (UCLA) Reaction Index'}], 'secondaryOutcomes': [{'measure': 'Maternal resilience', 'timeFrame': 'Measured immediately post-intervention', 'description': 'Adult Resilience Measure - revised (ARM-R)'}, {'measure': 'Maternal resilience', 'timeFrame': 'Measured 6-8 months post-intervention', 'description': 'Adult Resilience Measure - revised (ARM-R)'}, {'measure': 'Child resilience', 'timeFrame': 'Measured immediately post-intervention', 'description': 'Child \\& Youth Resilience Measure - revised (CYRM-R)'}, {'measure': 'Child resilience', 'timeFrame': 'Measured 6-8 months post-intervention', 'description': 'Child \\& Youth Resilience Measure - revised (CYRM-R)'}, {'measure': 'Maternal social support', 'timeFrame': 'Measured immediately post-intervention', 'description': 'Inventory of Socially Supportive Behaviors'}, {'measure': 'Maternal social support', 'timeFrame': 'Measured 6-8 months post-intervention', 'description': 'Inventory of Socially Supportive Behaviors'}, {'measure': 'Maternal self esteem', 'timeFrame': 'Measured immediately post-intervention', 'description': 'Rosenberg Self Esteem Scale'}, {'measure': 'Maternal self esteem', 'timeFrame': 'Measured 6-8 months post-intervention', 'description': 'Rosenberg Self Esteem Scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['domestic violence', 'exposure to violence'], 'conditions': ['Violence, Domestic']}, 'referencesModule': {'references': [{'pmid': '26030027', 'type': 'RESULT', 'citation': 'Graham-Bermann SA, Miller-Graff L. Community-based intervention for women exposed to intimate partner violence: A randomized control trial. J Fam Psychol. 2015 Aug;29(4):537-47. doi: 10.1037/fam0000091.'}, {'pmid': '25596929', 'type': 'RESULT', 'citation': 'Graham-Bermann SA, Miller-Graff LE, Howell KH, Grogan-Kaylor A. An Efficacy Trial of an Intervention Program for Children Exposed to Intimate Partner Violence. Child Psychiatry Hum Dev. 2015 Dec;46(6):928-39. doi: 10.1007/s10578-015-0532-4.'}, {'pmid': '17469878', 'type': 'RESULT', 'citation': 'Graham-Bermann SA, Lynch S, Banyard V, DeVoe ER, Halabu H. Community-based intervention for children exposed to intimate partner violence: an efficacy trial. J Consult Clin Psychol. 2007 Apr;75(2):199-209. doi: 10.1037/0022-006X.75.2.199.'}]}, 'descriptionModule': {'briefSummary': "Evaluation of Mother's Empowerment Program and Kid's Club Program adapted specifically for Indigenous mothers and children affected by intimate partner violence in Canada", 'detailedDescription': "Research Goals \\& Objectives. Our overall goal is to conduct a feasibility study of two successful evidence-based interventions (Mother's Empowerment Program and Kid's Club Program) designed specifically to meet the needs of Indigenous mothers and their children who have experienced intimate partner violence (IPV).\n\nSpecifically, our objectives are:\n\n1. To successfully adapt two existing effective evidence-based interventions for mothers and children who have experienced IPV for Indigenous mothers and children who have experienced IPV. Our adaptation process reflects our overall integrated knowledge translation (iKT) approach, undertaken in close partnership with our Community Advisory Council (CAC) and in consultation with Elders at both sites. As outlined by the Canadian Institutes of Health Research (CIHR), it follows a two-eyed seeing approach, incorporating Western and Indigenous knowledge, ways of knowing and being.\n2. To pilot and evaluate our adapted interventions with mothers and children recruited from our community partners (Wahbung Abinoonjiiag, an Indigenous non-profit organization in Winnipeg and Discovery House, a crisis shelter and second stage housing facility for women in Calgary). We plan to evaluate our adapted programs using a two-eyed seeing approach that combines Western (quantitative) and Indigenous (qualitative) methodologies. As part of our iKT approach, our mixed methods evaluation will rely upon ongoing engagement and feedback from our CAC. Quantitative methods (e.g., standardized questionnaires) will be used to assess changes in the mental and physical health and well-being of mothers and their children over time. Qualitative methods (e.g., semi-structured interviews, narratives) will be used to evaluate the intervention experience and perceived changes in self perceptions (e.g., resilience).\n\nHypotheses. We will determine if there is an increase, both immediately post-intervention and sustained over 6-8 months, in mothers' and children's mental (e.g., resilience) and physical well-being (e.g., perceived health status), and if there is a reduction in mothers' and children's mental health (e.g., depression, anxiety and traumatic stress symptoms) and physical difficulties (e.g., somatic symptoms such as headaches). For children, analyses will take age, gender and sex into account."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mothers self-reported experience of past intimate partner violence, English-speaking, with at least one school-aged child\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04235335', 'briefTitle': 'Healing Circles: An Intervention for Canadian Indigenous Mothers & Children Affected by IPV', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Healing Circles: An Evaluation of an Intervention for Canadian Indigenous Mothers and Children Affected by Intimate Partner Violence', 'orgStudyIdInfo': {'id': 'H2019:501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Wait List Control', 'description': 'Participants receive intervention after 12 week delay', 'interventionNames': ["Behavioral: Indigenous Mother's Empowerment Program & Indigenous Kid's Club Program"]}], 'interventions': [{'name': "Indigenous Mother's Empowerment Program & Indigenous Kid's Club Program", 'type': 'BEHAVIORAL', 'description': 'Weekly groups administered to mothers and children simultaneously but separately for 10 weeks', 'armGroupLabels': ['Wait List Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2A 7R7', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Executive Director', 'role': 'CONTACT', 'email': 'shelter@discoveryhouse.ca', 'phone': '403-670-0467'}], 'facility': 'Discovery House', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'centralContacts': [{'name': 'Caroline Piotrowski, PhD MPH', 'role': 'CONTACT', 'email': 'Caroline.Piotrowski@umanitoba.ca', 'phone': '1-800-555-5555'}, {'name': 'Nicole Letourneau, PhD RN', 'role': 'CONTACT', 'phone': '1-800-555-5555'}], 'overallOfficials': [{'name': 'Caroline Piotrowski, PhD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Caroline Piotrowski', 'investigatorAffiliation': 'University of Manitoba'}}}}