- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04235335
Healing Circles: An Intervention for Canadian Indigenous Mothers & Children Affected by IPV
Healing Circles: An Evaluation of an Intervention for Canadian Indigenous Mothers and Children Affected by Intimate Partner Violence
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Specifically, our objectives are:
- 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.
- 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).
Hypotheses. 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Caroline Piotrowski, PhD MPH
- Phone Number: 1-800-555-5555
- Email: Caroline.Piotrowski@umanitoba.ca
Study Contact Backup
- Name: Nicole Letourneau, PhD RN
- Phone Number: 1-800-555-5555
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2A 7R7
- Recruiting
- Discovery House
-
Contact:
- Executive Director
- Phone Number: 403-670-0467
- Email: shelter@discoveryhouse.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- mothers self-reported experience of past intimate partner violence, English-speaking, with at least one school-aged child
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Wait List Control
Participants receive intervention after 12 week delay
|
Weekly groups administered to mothers and children simultaneously but separately for 10 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal Depression
Time Frame: Measured immediately post-intervention
|
Centers for Epidemiological Studies-Depression (CES-D)
|
Measured immediately post-intervention
|
Maternal Depression
Time Frame: Measured 6-8 months post-intervention
|
Centers for Epidemiological Studies-Depression (CES-D)
|
Measured 6-8 months post-intervention
|
Child Depression
Time Frame: Measured Immediately post-intervention
|
Child Depression Inventory (CDI)
|
Measured Immediately post-intervention
|
Child Depression
Time Frame: Measured 6-8 months post-intervention
|
Child Depression Inventory (CDI)
|
Measured 6-8 months post-intervention
|
Maternal Anxiety
Time Frame: Measured Immediately post-intervention
|
Beck Anxiety Scale
|
Measured Immediately post-intervention
|
Maternal Anxiety
Time Frame: Measured 6-8 months post-intervention
|
Beck Anxiety Scale
|
Measured 6-8 months post-intervention
|
Child Anxiety
Time Frame: Measured immediately post-intervention
|
Revised Children's Manifest Anxiety Scale - 2nd Edition Short Form (RCMAS-2)
|
Measured immediately post-intervention
|
Child Anxiety
Time Frame: Measured 6-8 months post-intervention
|
Revised Children's Manifest Anxiety Scale - 2nd Edition Short Form (RCMAS-2)
|
Measured 6-8 months post-intervention
|
Maternal trauma symptoms
Time Frame: Measured immediately post-intervention
|
PTSD Checklist (PCL-5)
|
Measured immediately post-intervention
|
Maternal trauma symptoms
Time Frame: Measured 6-8 months post-intervention
|
PTSD Checklist (PCL-5)
|
Measured 6-8 months post-intervention
|
Child trauma symptoms
Time Frame: Measured immediately post-intervention
|
University of California - Los Angeles (UCLA) Reaction Index
|
Measured immediately post-intervention
|
Child trauma symptoms
Time Frame: Measured 6-8 months post-intervention
|
University of California - Los Angeles (UCLA) Reaction Index
|
Measured 6-8 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal resilience
Time Frame: Measured immediately post-intervention
|
Adult Resilience Measure - revised (ARM-R)
|
Measured immediately post-intervention
|
Maternal resilience
Time Frame: Measured 6-8 months post-intervention
|
Adult Resilience Measure - revised (ARM-R)
|
Measured 6-8 months post-intervention
|
Child resilience
Time Frame: Measured immediately post-intervention
|
Child & Youth Resilience Measure - revised (CYRM-R)
|
Measured immediately post-intervention
|
Child resilience
Time Frame: Measured 6-8 months post-intervention
|
Child & Youth Resilience Measure - revised (CYRM-R)
|
Measured 6-8 months post-intervention
|
Maternal social support
Time Frame: Measured immediately post-intervention
|
Inventory of Socially Supportive Behaviors
|
Measured immediately post-intervention
|
Maternal social support
Time Frame: Measured 6-8 months post-intervention
|
Inventory of Socially Supportive Behaviors
|
Measured 6-8 months post-intervention
|
Maternal self esteem
Time Frame: Measured immediately post-intervention
|
Rosenberg Self Esteem Scale
|
Measured immediately post-intervention
|
Maternal self esteem
Time Frame: Measured 6-8 months post-intervention
|
Rosenberg Self Esteem Scale
|
Measured 6-8 months post-intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Caroline Piotrowski, PhD MPH, University of Manitoba
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H2019:501
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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