Evaluating Trauma-Informed, Evidence-Informed Interventions for Latino Families Experiencing Domestic Violence

• ClinicalTrials.gov Identifier: NCT03041558
• Recruitment Status: Active, not recruiting
• First Posted: February 2, 2017
• Last Update Posted: June 27, 2019
• Sponsor: University of California, San Diego
• 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
• Information provided by (Responsible Party): Gregory Aarons, University of California, San Diego

Tracking Information

• First Submitted Date: January 31, 2017
• First Posted Date: February 2, 2017
• Last Update Posted Date: June 27, 2019
• Study Start Date: September 2013
• Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 31, 2017)

• 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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluating Trauma-Informed, Evidence-Informed Interventions for Latino Families Experiencing Domestic Violence
• Official Title: SafeCare+: Implementing & Evaluating Trauma-Informed, Evidence-Informed Interventions for Latino Families Experiencing Domestic Violence & Child Maltreatment
• Brief Summary: 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Single (Participant); Primary Purpose: Health Services Research
• Condition: Interpersonal Relations

Intervention

• Behavioral: SafeCare+ (SC+)
  SafeCare intervention with the additional Healthy Relationships (HR) module
• Behavioral: SafeCare (SC)
  SafeCare intervention as usual

Study Arms

• Experimental: SafeCare+ (SC+)
  SafeCare intervention with the additional Healthy Relationships (HR) module
  Intervention: Behavioral: SafeCare+ (SC+)
• Active Comparator: SafeCare (SC)
  SafeCare intervention as usual
  Intervention: Behavioral: SafeCare (SC)

• 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+®. Pilot Feasibility Stud. 2020 Oct 8;6:153. doi: 10.1186/s40814-020-00681-3. eCollection 2020.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: January 31, 2017): 160
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2020
• Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03041558
• Other Study ID Numbers: 20140475
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Gregory Aarons, University of California, San Diego
• Study Sponsor: University of California, San Diego

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

• Investigators: Not Provided
• PRS Account: University of California, San Diego
• Verification Date: June 2019