ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 16 for:    Recruiting, Not yet recruiting, Available Studies | "Child Abuse"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03041558
Recruitment Status : Recruiting
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
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

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 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 : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041558


Contacts
Contact: Gregory Aarons, PhD 8589667703 ext 3550 gaarons@ucsd.edu
Contact: Joella Phillips, BA 8589667703 ext 2695 jiphillips@ucsd.edu

Locations
United States, California
UC San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Joella Phillips, BA    858-966-7703 ext 2695    jiphillips@ucsd.edu   
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

Responsible Party: Gregory Aarons, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03041558     History of Changes
Other Study ID Numbers: 20140475
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017
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