Violence, DomesticNCT04235335
Healing Circles: An Intervention for Canadian Indigenous Mothers & Children Affected by IPV
A study testing Indigenous Mother's Empowerment Program & Indigenous Kid's Club Program in people with Violence, Domestic, run by University of Manitoba at 1 site in Canada.
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 Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Violence, Domestic
- What is being tested?
- Indigenous Mother's Empowerment Program & Indigenous Kid's Club Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- 23 Feb 2024to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- mothers self-reported experience of past intimate partner violence, English-speaking, with at least one school-aged child
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Nicole Letourneau, PhD RN contact
Canada1 site, 1 recruiting
- Recruiting
Discovery House
Calgary, Alberta, T2A 7R7
Executive Director, 403-670-0467, shelter@discoveryhouse.ca
About this study
Official title: Healing Circles: An Evaluation of an Intervention for Canadian Indigenous Mothers and Children Affected by Intimate Partner Violence
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
Read the 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.
- Conditions
- Violence, Domestic
- Being tested
- Indigenous Mother's Empowerment Program & Indigenous Kid's Club Program
- Keywords
- domestic violence, exposure to violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indigenous Mother's Empowerment Program & Indigenous Kid's Club ProgramBehavioural
Weekly groups administered to mothers and children simultaneously but separately for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Wait List Control | Other | Participants receive intervention after 12 week delay Receives: Behavioral: Indigenous Mother's Empowerment Program & Indigenous Kid's Club Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Depression
Centers for Epidemiological Studies-Depression (CES-D)
Measured: Measured immediately post-intervention
Maternal Depression
Centers for Epidemiological Studies-Depression (CES-D)
Measured: Measured 6-8 months post-intervention
Child Depression
Child Depression Inventory (CDI)
Measured: Measured Immediately post-intervention
Child Depression
Child Depression Inventory (CDI)
Measured: Measured 6-8 months post-intervention
Maternal Anxiety
Beck Anxiety Scale
Measured: Measured Immediately post-intervention
Maternal Anxiety
Beck Anxiety Scale
Measured: Measured 6-8 months post-intervention
Child Anxiety
Revised Children's Manifest Anxiety Scale - 2nd Edition Short Form (RCMAS-2)
Measured: Measured immediately post-intervention
Child Anxiety
Revised Children's Manifest Anxiety Scale - 2nd Edition Short Form (RCMAS-2)
Measured: Measured 6-8 months post-intervention
Maternal trauma symptoms
PTSD Checklist (PCL-5)
Measured: Measured immediately post-intervention
Maternal trauma symptoms
PTSD Checklist (PCL-5)
Measured: Measured 6-8 months post-intervention
Child trauma symptoms
University of California - Los Angeles (UCLA) Reaction Index
Measured: Measured immediately post-intervention
Child trauma symptoms
University of California - Los Angeles (UCLA) Reaction Index
Measured: Measured 6-8 months post-intervention
Secondary outcomes (8)
Maternal resilience
Adult Resilience Measure - revised (ARM-R)
Measured: Measured immediately post-intervention
Maternal resilience
Adult Resilience Measure - revised (ARM-R)
Measured: Measured 6-8 months post-intervention
Child resilience
Child \& Youth Resilience Measure - revised (CYRM-R)
Measured: Measured immediately post-intervention
Child resilience
Child \& Youth Resilience Measure - revised (CYRM-R)
Measured: Measured 6-8 months post-intervention
Maternal social support
Inventory of Socially Supportive Behaviors
Measured: Measured immediately post-intervention
Maternal social support
Inventory of Socially Supportive Behaviors
Measured: Measured 6-8 months post-intervention
Maternal self esteem
Rosenberg Self Esteem Scale
Measured: Measured immediately post-intervention
Maternal self esteem
Rosenberg Self Esteem Scale
Measured: Measured 6-8 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start23 Feb 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Violence, DomesticStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Caroline Piotrowski, University of Manitoba
- Investigators
- Caroline Piotrowski, PhD MPH, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235335
- Sponsor's protocol ID
- H2019:501
- Status last verified
- Mar 2024
- First submitted
- 15 Jan 2020
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26030027Graham-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.
PubMed 25596929Graham-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.
PubMed 17469878
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Circles: An Evaluation of an Intervention for Canadian Indigenous Mothers and Children Affected by Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT04235335
- Acronym / sponsor ID
- H2019:501
- Conditions
- Violence, Domestic
- Keywords
- domestic violence, exposure to violence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wait List Control | Other | Behavioral: Indigenous Mother's Empowerment Program & Indigenous Kid's Club ProgramParticipants receive intervention after 12 week delay |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- mothers self-reported experience of past intimate partner violence, English-speaking, with at least one school-aged child
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indigenous Mother's Empowerment Program & Indigenous Kid's Club ProgramWeekly groups administered to mothers and children simultaneously but separately for 10 weeks | Behavioural | Wait List Control |
Primary outcome
Maternal Depression
Time frame: Measured immediately post-intervention
Centers for Epidemiological Studies-Depression (CES-D)
Maternal Depression
Time frame: Measured 6-8 months post-intervention
Centers for Epidemiological Studies-Depression (CES-D)
Child Depression
Time frame: Measured Immediately post-intervention
Child Depression Inventory (CDI)
Child Depression
Time frame: Measured 6-8 months post-intervention
Child Depression Inventory (CDI)
Maternal Anxiety
Time frame: Measured Immediately post-intervention
Beck Anxiety Scale
Maternal Anxiety
Time frame: Measured 6-8 months post-intervention
Beck Anxiety Scale
Child Anxiety
Time frame: Measured immediately post-intervention
Revised Children's Manifest Anxiety Scale - 2nd Edition Short Form (RCMAS-2)
Child Anxiety
Time frame: Measured 6-8 months post-intervention
Revised Children's Manifest Anxiety Scale - 2nd Edition Short Form (RCMAS-2)
Maternal trauma symptoms
Time frame: Measured immediately post-intervention
PTSD Checklist (PCL-5)
Maternal trauma symptoms
Time frame: Measured 6-8 months post-intervention
PTSD Checklist (PCL-5)
Child trauma symptoms
Time frame: Measured immediately post-intervention
University of California - Los Angeles (UCLA) Reaction Index
Child trauma symptoms
Time frame: Measured 6-8 months post-intervention
University of California - Los Angeles (UCLA) Reaction Index
8 secondary outcomes
Maternal resilience
Time frame: Measured immediately post-intervention
Maternal resilience
Time frame: Measured 6-8 months post-intervention
Child resilience
Time frame: Measured immediately post-intervention
Child resilience
Time frame: Measured 6-8 months post-intervention
Maternal social support
Time frame: Measured immediately post-intervention
Maternal social support
Time frame: Measured 6-8 months post-intervention
Maternal self esteem
Time frame: Measured immediately post-intervention
Maternal self esteem
Time frame: Measured 6-8 months post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Results publication: PubMed 26030027Graham-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.
- Results publication: PubMed 25596929Graham-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.
- Results publication: PubMed 17469878Graham-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Letourneau, PhD RN contact
Caroline Piotrowski, PhD MPH principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indigenous Mother's Empowerment Program & Indigenous Kid's Club Program in people with Violence, Domestic, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Piotrowski, PhD MPH (1-800-555-5555, Caroline.Piotrowski@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Depression (time frame: Measured immediately post-intervention). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04235335, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.