NCT04235335

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Feb 2024Jul 2026

First Submitted

Initial submission to the registry

January 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 21, 2020

Completed
4.1 years until next milestone

Study Start

First participant enrolled

February 23, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Expected
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1.9 years

First QC Date

January 15, 2020

Last Update Submit

March 13, 2024

Conditions

Violence, Domestic

Keywords

domestic violenceexposure to violence

Outcome Measures

Primary Outcomes (12)

  • Maternal Depression

    Centers for Epidemiological Studies-Depression (CES-D)

    Measured immediately post-intervention

  • Maternal Depression

    Centers for Epidemiological Studies-Depression (CES-D)

    Measured 6-8 months post-intervention

  • Child Depression

    Child Depression Inventory (CDI)

    Measured Immediately post-intervention

  • Child Depression

    Child Depression Inventory (CDI)

    Measured 6-8 months post-intervention

  • Maternal Anxiety

    Beck Anxiety Scale

    Measured Immediately post-intervention

  • Maternal Anxiety

    Beck Anxiety Scale

    Measured 6-8 months post-intervention

  • Child Anxiety

    Revised Children's Manifest Anxiety Scale - 2nd Edition Short Form (RCMAS-2)

    Measured immediately post-intervention

  • Child Anxiety

    Revised Children's Manifest Anxiety Scale - 2nd Edition Short Form (RCMAS-2)

    Measured 6-8 months post-intervention

  • Maternal trauma symptoms

    PTSD Checklist (PCL-5)

    Measured immediately post-intervention

  • Maternal trauma symptoms

    PTSD Checklist (PCL-5)

    Measured 6-8 months post-intervention

  • Child trauma symptoms

    University of California - Los Angeles (UCLA) Reaction Index

    Measured immediately post-intervention

  • Child trauma symptoms

    University of California - Los Angeles (UCLA) Reaction Index

    Measured 6-8 months post-intervention

Secondary Outcomes (8)

  • Maternal resilience

    Measured immediately post-intervention

  • Maternal resilience

    Measured 6-8 months post-intervention

  • Child resilience

    Measured immediately post-intervention

  • Child resilience

    Measured 6-8 months post-intervention

  • Maternal social support

    Measured immediately post-intervention

  • +3 more secondary outcomes

Study Arms (1)

Wait List Control

OTHER

Participants receive intervention after 12 week delay

Behavioral: Indigenous Mother's Empowerment Program & Indigenous Kid's Club Program

Interventions

Indigenous Mother's Empowerment Program & Indigenous Kid's Club ProgramBEHAVIORAL

Weekly groups administered to mothers and children simultaneously but separately for 10 weeks

Wait List Control

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • mothers self-reported experience of past intimate partner violence, English-speaking, with at least one school-aged child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Discovery House

Calgary, Alberta, T2A 7R7, Canada

RECRUITING

Related Publications (3)

  • 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: 26030027RESULT

  • 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: 25596929RESULT

  • 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.

    PMID: 17469878RESULT

Study Officials

  • Caroline Piotrowski, PhD MPH

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Piotrowski, PhD MPH

CONTACT

1-800-555-5555Caroline.Piotrowski@umanitoba.ca

Nicole Letourneau, PhD RN

CONTACT

1-800-555-5555

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 21, 2020

Study Start

February 23, 2024

Primary Completion

December 30, 2025

Study Completion (Estimated)

July 30, 2026

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)