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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04235335
Other study ID # H2019:501
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 23, 2024
Est. completion date July 30, 2026

Study information

Verified date March 2024
Source University of Manitoba
Contact Caroline Piotrowski, PhD MPH
Phone 1-800-555-5555
Email Caroline.Piotrowski@umanitoba.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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: 1. 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. 2. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date July 30, 2026
Est. primary completion date December 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 13 Years
Eligibility Inclusion Criteria: - mothers self-reported experience of past intimate partner violence, English-speaking, with at least one school-aged child Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Indigenous Mother's Empowerment Program & Indigenous Kid's Club Program
Weekly groups administered to mothers and children simultaneously but separately for 10 weeks

Locations

Country Name City State
Canada Discovery House Calgary Alberta

Sponsors (2)

Lead Sponsor Collaborator
University of Manitoba Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Maternal Depression Centers for Epidemiological Studies-Depression (CES-D) Measured immediately post-intervention
Primary Maternal Depression Centers for Epidemiological Studies-Depression (CES-D) Measured 6-8 months post-intervention
Primary Child Depression Child Depression Inventory (CDI) Measured Immediately post-intervention
Primary Child Depression Child Depression Inventory (CDI) Measured 6-8 months post-intervention
Primary Maternal Anxiety Beck Anxiety Scale Measured Immediately post-intervention
Primary Maternal Anxiety Beck Anxiety Scale Measured 6-8 months post-intervention
Primary Child Anxiety Revised Children's Manifest Anxiety Scale - 2nd Edition Short Form (RCMAS-2) Measured immediately post-intervention
Primary Child Anxiety Revised Children's Manifest Anxiety Scale - 2nd Edition Short Form (RCMAS-2) Measured 6-8 months post-intervention
Primary Maternal trauma symptoms PTSD Checklist (PCL-5) Measured immediately post-intervention
Primary Maternal trauma symptoms PTSD Checklist (PCL-5) Measured 6-8 months post-intervention
Primary Child trauma symptoms University of California - Los Angeles (UCLA) Reaction Index Measured immediately post-intervention
Primary Child trauma symptoms University of California - Los Angeles (UCLA) Reaction Index Measured 6-8 months post-intervention
Secondary Maternal resilience Adult Resilience Measure - revised (ARM-R) Measured immediately post-intervention
Secondary Maternal resilience Adult Resilience Measure - revised (ARM-R) Measured 6-8 months post-intervention
Secondary Child resilience Child & Youth Resilience Measure - revised (CYRM-R) Measured immediately post-intervention
Secondary Child resilience Child & Youth Resilience Measure - revised (CYRM-R) Measured 6-8 months post-intervention
Secondary Maternal social support Inventory of Socially Supportive Behaviors Measured immediately post-intervention
Secondary Maternal social support Inventory of Socially Supportive Behaviors Measured 6-8 months post-intervention
Secondary Maternal self esteem Rosenberg Self Esteem Scale Measured immediately post-intervention
Secondary Maternal self esteem Rosenberg Self Esteem Scale Measured 6-8 months post-intervention
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