NCT05948631

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

2.2 years

First QC Date

June 16, 2023

Last Update Submit

December 4, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Mental health problems

    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

    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.

Study Arms (2)

MISC

EXPERIMENTAL

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.

Behavioral: MISC intervention

Treatment as Usual

ACTIVE COMPARATOR

Treatment as Usual in the rehousing program. Mothers receive support in a domestic violence rehousing program to find work and housing.

Behavioral: Treatment as Usual (TAU)

Interventions

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.

MISC

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).

Treatment as Usual

Eligibility Criteria

Age7 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled in Harris County Domestic Violence rehousing program
  • Fluency in English

You may not qualify if:

  • Active suicidality
  • Intellectual disability
  • Active psychotic disorder
  • Exposure to domestic violence
  • years old in a family
  • Intelligence quotient below 75,
  • Active psychosis
  • Severe autism
  • Below age 7 or above age 11

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

RECRUITING

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Carla Sharp

    csharp2@uh.edu

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla Sharp, Ph.D.

CONTACT

Madeleine Allman, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
John and Rebecca Moores Professor and Associate Dean

Study Record Dates

First Submitted

June 16, 2023

First Posted

July 17, 2023

Study Start

February 14, 2023

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

December 9, 2024

Record last verified: 2024-12

Locations