MISC InterventionMISC-IPVNCT05948631
MISC-IPV: A Community-Based Intervention for Children Traumatized by Intimate Partner Violence
A study testing MISC intervention and Treatment as Usual (TAU) in people with MISC Intervention and Treatment as Usual, run by University of Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- MISC Intervention, Treatment as Usual
- What is being tested?
- MISC intervention and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2023to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- MISC Intervention, Treatment as Usual
- Being tested
- MISC intervention, Treatment as Usual (TAU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MISC interventionBehavioural
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.
Treatment as Usual (TAU)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, six, 12, and 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start14 Feb 2023
- Primary completion30 Mar 2026
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MISC InterventionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla Sharp, University of Houston
- Investigators
- Carla Sharp, Principal investigator, csharp2@uh.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948631
- Sponsor's protocol ID
- STUDY00001728
- Acronym
- MISC-IPV
- Status last verified
- Aug 2026
- First submitted
- 16 Jun 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MISC-IPV: A Community-Based Intervention for Children Traumatized by Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT05948631
- Acronym / sponsor ID
- MISC-IPV / STUDY00001728
- Conditions
- MISC Intervention, Treatment as Usual
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 17 Jul 2023 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MISC | Experimental | Behavioral: MISC interventionMediational 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. |
| Treatment as Usual | Active comparator | Behavioral: Treatment as Usual (TAU)Treatment as Usual in the rehousing program. Mothers receive support in a domestic violence rehousing program to find work and housing. |
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| MISC interventionMISC 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. | Behavioural | MISC |
| Treatment as Usual (TAU)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). | Behavioural | Treatment as Usual |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Undecided
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.
Carla Sharp principal investigator
csharp2@uh.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MISC intervention and Treatment as Usual (TAU) in people with MISC Intervention and Treatment as Usual, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental health problems (time frame: Baseline, six, 12, and 18 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2026.