Interpersonal RelationsNCT03041558
Evaluating Trauma-Informed, Evidence-Informed Interventions for Latino Families Experiencing Domestic Violence
A study testing SafeCare+ (SC+) and SafeCare (SC) in people with Interpersonal Relations, run by University of California, San Diego at 1 site in United States.
Trial summary
This project will evaluate the implementation and efficacy of a domestic violence intervention module for parents receiving child welfare home visitation services. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Interpersonal Relations
- What is being tested?
- SafeCare+ (SC+) and SafeCare (SC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jun 2020
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Service providers (CWS and DV) and active CW clients with DV histories will be recruited via random selection to participate in focus groups during the planning year of the project.
- Latino families are eligible for the RCT based on the following criteria: (a) being identified as an appropriate family for SafeCare; and (b) by having at least one, qualifying DV experience, which will be determined during the baseline needs assessment.
Who cannot join
- A client will be excluded if he/she indicates to the service provider that they are unable to comprehend the written questionnaire and cannot obtain outside assistance in understanding and completing the questionnaire.
- Clients under the age of 18 will able be excluded because they cannot provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SafeCare+: Implementing & Evaluating Trauma-Informed, Evidence-Informed Interventions for Latino Families Experiencing Domestic Violence & Child Maltreatment
This project will evaluate the implementation and efficacy of a domestic violence intervention module for parents receiving child welfare home visitation services.
Read the detailed description
The ultimate goal of this proposed project is the provision of culturally-relevant, trauma-informed services leading to a reduction of family violence, and a resultant increase in family stability, improved communication, and a healthy home environment for children in Latino families with co-occurring domestic violence (DV) and child abuse/neglect (CAN). The Administration for Children, Youth and Families (ACYF) funded project and evaluation will be layered onto the existing UC San Diego's NIH-funded R01 research (NIH R01 MH092950) on scale-up of SafeCare (SC) across the entire San Diego Child Welfare System. In the first phase of this project, the community and academic partners will collaborate to develop a detailed evaluation plan by collecting formative qualitative data via focus groups with active CW clients with domestic violence (DV) histories and community child welfare and DV service providers. The second phase of this project will begin with the implementation of SafeCare+ (SC+), an evidence-based training curriculum for parents referred for child maltreatment, coupled with the Healthy Relationships (HR) module for Latino families with co-occurring child maltreatment and domestic violence experiences. SafeCare® (SC) has been shown to be widely accepted among the Latino community and the HR module has been specifically adapted for and successfully utilized with Latino populations. As part of the expansion of the original research study, 80 clients who will be recruited into the existing study will also be randomly assigned to receive the additional HR module.
- Conditions
- Interpersonal Relations
- Being tested
- SafeCare+ (SC+), SafeCare (SC)
- Keywords
- healthy relationships, interpersonal relations, domestic violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafeCare+ (SC+)Behavioural
SafeCare intervention with the additional Healthy Relationships (HR) module
SafeCare (SC)Behavioural
SafeCare intervention as usual
| Study group | Role | What they receive |
|---|---|---|
| SafeCare+ (SC+) | Experimental | SafeCare intervention with the additional Healthy Relationships (HR) module Receives: Behavioral: SafeCare+ (SC+) |
| SafeCare (SC) | Active comparator | SafeCare intervention as usual Receives: Behavioral: SafeCare (SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fidelity
Fidelity monitoring will begin simultaneously with the implementation of SafeCare (SC®). Fidelity is assessed largely via client report, with clients completing a fidelity questionnaire at the end of every SC or SC+ session. A secondary fidelity component utilizes information gained from the natural implementation of SC®. SC+ includes ongoing consultation in the form of expert SC® clinicians who accompany home visitors, observe their interactions with families, and coach them on improving performance and services.
Measured: 4 years
Change in level of domestic violence
The Conflict Tactic Scale (CTS2): measures both the extent to which partners in a dating, cohabiting, or marital relationship engage in psychological and physical attacks on each other and also their use of reasoning or negotiation to deal with conflicts.
Measured: 4 years
Client depression
The Center for Epidemiologic Studies Depression Scale (CES-D) (Radloff, 1977) is a 20-item questionnaire which assesses depressive symptomology.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study startSep 2013
- Primary completionJan 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interpersonal RelationsStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- South Bay Community Services, University of Southern California, San Diego County Child Welfare Services, University of Oklahoma, Children's Bureau - Administration for Children and Families
- Responsible party
- Principal investigator, Gregory Aarons, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041558
- Sponsor's protocol ID
- 20140475
- Status last verified
- May 2021
- First submitted
- 31 Jan 2017
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fettes DL, Aarons GA, Brew V, Ledesma K, Silovsky J. Implementation of a trauma-informed, evidence-informed intervention for Latinx families experiencing interpersonal violence and child maltreatment: protocol for a pilot randomized control trial of SafeCare+(R). Pilot Feasibility Stud. 2020 Oct 8;6:153. doi: 10.1186/s40814-020-00681-3. eCollection 2020.
PubMed 33062294
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SafeCare+: Implementing & Evaluating Trauma-Informed, Evidence-Informed Interventions for Latino Families Experiencing Domestic Violence & Child Maltreatment
- ClinicalTrials.gov ID
- NCT03041558
- Acronym / sponsor ID
- 20140475
- Conditions
- Interpersonal Relations
- Keywords
- healthy relationships, interpersonal relations, domestic violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- South Bay Community Services, University of Southern California, San Diego County Child Welfare Services, University of Oklahoma, Children's Bureau - Administration for Children and Families
- Study start
- Sep 2013 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 2 Feb 2017 (estimated)
- 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 project will evaluate the implementation and efficacy of a domestic violence intervention module for parents receiving child welfare home visitation services.
Detailed description
The ultimate goal of this proposed project is the provision of culturally-relevant, trauma-informed services leading to a reduction of family violence, and a resultant increase in family stability, improved communication, and a healthy home environment for children in Latino families with co-occurring domestic violence (DV) and child abuse/neglect (CAN). The Administration for Children, Youth and Families (ACYF) funded project and evaluation will be layered onto the existing UC San Diego's NIH-funded R01 research (NIH R01 MH092950) on scale-up of SafeCare (SC) across the entire San Diego Child Welfare System. In the first phase of this project, the community and academic partners will collaborate to develop a detailed evaluation plan by collecting formative qualitative data via focus groups with active CW clients with domestic violence (DV) histories and community child welfare and DV service providers. The second phase of this project will begin with the implementation of SafeCare+ (SC+), an evidence-based training curriculum for parents referred for child maltreatment, coupled with the Healthy Relationships (HR) module for Latino families with co-occurring child maltreatment and domestic violence experiences. SafeCare® (SC) has been shown to be widely accepted among the Latino community and the HR module has been specifically adapted for and successfully utilized with Latino populations. As part of the expansion of the original research study, 80 clients who will be recruited into the existing study will also be randomly assigned to receive the additional HR module.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SafeCare+ (SC+) | Experimental | Behavioral: SafeCare+ (SC+)SafeCare intervention with the additional Healthy Relationships (HR) module |
| SafeCare (SC) | Active comparator | Behavioral: SafeCare (SC)SafeCare intervention as usual |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Service providers (CWS and DV) and active CW clients with DV histories will be recruited via random selection to participate in focus groups during the planning year of the project.
- Latino families are eligible for the RCT based on the following criteria: (a) being identified as an appropriate family for SafeCare; and (b) by having at least one, qualifying DV experience, which will be determined during the baseline needs assessment.
Key exclusion criteria (2 listed)
- A client will be excluded if he/she indicates to the service provider that they are unable to comprehend the written questionnaire and cannot obtain outside assistance in understanding and completing the questionnaire.
- Clients under the age of 18 will able be excluded because they cannot provide informed consent.
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 |
|---|---|---|
| SafeCare+ (SC+)SafeCare intervention with the additional Healthy Relationships (HR) module | Behavioural | SafeCare+ (SC+) |
| SafeCare (SC)SafeCare intervention as usual | Behavioural | SafeCare (SC) |
Primary outcome
Fidelity
Time frame: 4 years
Fidelity monitoring will begin simultaneously with the implementation of SafeCare (SC®). Fidelity is assessed largely via client report, with clients completing a fidelity questionnaire at the end of every SC or SC+ session. A secondary fidelity component utilizes information gained from the natural implementation of SC®. SC+ includes ongoing consultation in the form of expert SC® clinicians who accompany home visitors, observe their interactions with families, and coach them on improving performance and services.
Change in level of domestic violence
Time frame: 4 years
The Conflict Tactic Scale (CTS2): measures both the extent to which partners in a dating, cohabiting, or marital relationship engage in psychological and physical attacks on each other and also their use of reasoning or negotiation to deal with conflicts.
Client depression
Time frame: 4 years
The Center for Epidemiologic Studies Depression Scale (CES-D) (Radloff, 1977) is a 20-item questionnaire which assesses depressive symptomology.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Derived from this study: PubMed 33062294Fettes DL, Aarons GA, Brew V, Ledesma K, Silovsky J. Implementation of a trauma-informed, evidence-informed intervention for Latinx families experiencing interpersonal violence and child maltreatment: protocol for a pilot randomized control trial of SafeCare+(R). Pilot Feasibility Stud. 2020 Oct 8;6:153. doi: 10.1186/s40814-020-00681-3. eCollection 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SafeCare+ (SC+) and SafeCare (SC) in people with Interpersonal Relations, run by University of California, San Diego 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?
The sponsor lists 2 inclusion and 2 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: finished, as of the sponsor's last update on 25 May 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fidelity (time frame: 4 years). The study lists 3 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 NCT03041558, which also lists 1 linked publication.
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 25 May 2021.