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

Study Description

Brief Summary:

This project will evaluate the implementation and efficacy of a domestic violence intervention module for parents receiving child welfare home visitation services.

Condition or disease	Intervention/treatment	Phase
Interpersonal Relations	Behavioral: SafeCare+ (SC+); Behavioral: SafeCare (SC)	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: SafeCare+: Implementing & Evaluating Trauma-Informed, Evidence-Informed Interventions for Latino Families Experiencing Domestic Violence & Child Maltreatment
• Study Start Date: September 2013
• Estimated Primary Completion Date: January 2020
• Estimated Study Completion Date: June 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, California

UC San Diego

La Jolla, California, United States, 92093

Sponsors and Collaborators

University of California, San Diego

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Gregory Aarons, Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT03041558
• Other Study ID Numbers: 20140475
• First Posted: February 2, 2017
• Last Update Posted: June 27, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Gregory Aarons, University of California, San Diego:

healthy relationships; interpersonal relations; domestic violence