- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05948631
MISC-IPV: a Community-Based Intervention for Children Traumatized by Intimate Partner Violence (MISC-IPV)
December 4, 2024 updated by: Carla Sharp, University of Houston
This study adapts and evaluates preliminary outcomes of the Mediational Intervention for Sensitizing Caregivers (MISC) for women and children of color who have survived domestic violence.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The investigators propose that the adverse effects of Intimate Partner Violence (IPV) trauma on children can be interrupted through an intervention that enhances maternal caregiving capacity delivered by paraprofessional caseworkers.
The objective of this application is to adapt an established caregiver intervention program, Mediational Intervention for Sensitizing Caregivers (MISC), for the IPV context (thereafter named MISC-IPV).
Guided by an evidence-based framework for adapting caregiver-child training programs, the investigators take a three-phase approach (Adapt, Process Evaluation, Outcome/Mediator Evaluation) with the central hypothesis that acceptability and feasibility of MISC-IPV will be demonstrated and that MISC-IPV will show positive preliminary outcomes through the mechanism of enhanced maternal caregiving.
In acknowledgement of significant health disparities faced by IPV-affected African American women, the investigators will conduct our research with African American women and their children.
Successful completion of the project will result in a scalable community-based approach to IPV exposure that may provide a model for future integration of child-focused work into existing woman-focused IPV programs.
Study Type
Interventional
Enrollment (Estimated)
132
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carla Sharp, Ph.D.
- Phone Number: 7137438612
- Email: csharp2@uh.edu
Study Contact Backup
- Name: Madeleine Allman, MA
- Phone Number: 7137438612
- Email: meallman@central.uh.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77204
- Recruiting
- University of Houston
-
Contact:
- Carla Sharp, Ph.D.
- Email: csharp2@uh.edu
-
Contact:
- Madeleine Allman, MA
- Email: meallman@central.uh.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Mother inclusion criteria:
- Enrolled in Harris County Domestic Violence rehousing program
- Fluency in English
Mother exclusion criteria:
- Active suicidality
- Intellectual disability
- Active psychotic disorder
Child inclusion criteria:
- Exposure to domestic violence
- 7-11 years old in a family
Child exclusion criteria:
- Intelligence quotient below 75,
- Active psychosis
- Severe autism
- Below age 7 or above age 11
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MISC
Mediational Intervention for Sensitizing Caregivers (MISC): a program for mother and children where mothers become sensitized to the impact of their behavior on their children with the aim of improving quality caregiving and child outcomes.
|
MISC is a semi-structured, participatory caregiver intervention following these steps: (1) Identify the mother's personal and cultural characteristics, which include a respectful discussion around the mother's child-rearing views, objectives, needs and expectations.
(2) Create a baseline through videotaped interactions.
(3) Create caregivers' personal interaction profile on the basis of videotaped interaction.
The caseworker builds on the initial videotaped interaction and uses subsequent bi-weekly videotaped interactions to give feedback to mothers on the frequency of mediational behaviors thereby quantifying the quality of mother-child interactions.
Interactional characteristics are jointly identified and conceptualized according to MISC principles.
The mother learns to understand both her own and the child's behavior within a meaningful framework, enhancing reflection of caregiving practices.
(4) In-service training (once a month).
(5) Re-evaluate training efficacy.
|
|
Active Comparator: Treatment as Usual
Treatment as Usual in the rehousing program.
Mothers receive support in a domestic violence rehousing program to find work and housing.
|
TAU consists of supportive services including trauma informed, client-centered, and strength-based case management and advocacy.
All services are focused on the mother and do not include any child-focused intervention.
Instead, staff provide in-home intensive case management services to assess and provide safety planning, assess other social service needs, link abused mothers to community resources, and assist clients in rehousing.
TAU direct contact with the mother consists of bi-weekly contact, which matches the contact frequency for the intervention group.
However, MISC mothers will be receiving TAU+MISC-IPV (2 hours bi-weekly contact) compared with TAU only (30 minutes biweekly contact).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental health problems
Time Frame: Baseline, six, 12, and 18 months.
|
The primary outcome measure is change in mental health outcomes as assessed through by the Strengths and Difficulties Questionnaire (SDQ).
The SDQ total score indexes the overall level of mental health problems a child is experiencing with a minimum score of 0 and a maximum score of 60.
A higher the score indicates higher the levels of mental health problems.
|
Baseline, six, 12, and 18 months.
|
|
Sensitive caregiving
Time Frame: Baseline, six, 12, and 18 months.
|
Change in sensitive caregiving is a primary outcome that will be assessed with an observational tool named the Observing Mediational Interaction (OMI) tool.
The measure codes the frequency of caregiving behaviors that are sensitive to the child's needs.
It has a minimum of 0, but has no maximum as any frequency of behaviors may be observed.
A higher score indicates more sensitive caregiving.
|
Baseline, six, 12, and 18 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Carla Sharp, csharp2@uh.edu
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 14, 2023
Primary Completion (Estimated)
April 30, 2025
Study Completion (Estimated)
April 30, 2025
Study Registration Dates
First Submitted
June 16, 2023
First Submitted That Met QC Criteria
July 6, 2023
First Posted (Actual)
July 17, 2023
Study Record Updates
Last Update Posted (Estimated)
December 9, 2024
Last Update Submitted That Met QC Criteria
December 4, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00001728
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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