NCT03041558

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

6.3 years

First QC Date

January 31, 2017

Last Update Submit

May 21, 2021

Conditions

Keywords

healthy relationshipsinterpersonal relationsdomestic violence

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    4 years

  • Client depression

    The Center for Epidemiologic Studies Depression Scale (CES-D) (Radloff, 1977) is a 20-item questionnaire which assesses depressive symptomology.

    4 years

Study Arms (2)

SafeCare+ (SC+)

EXPERIMENTAL

SafeCare intervention with the additional Healthy Relationships (HR) module

Behavioral: SafeCare+ (SC+)

SafeCare (SC)

ACTIVE COMPARATOR

SafeCare intervention as usual

Behavioral: SafeCare (SC)

Interventions

SafeCare (SC)BEHAVIORAL

SafeCare intervention as usual

SafeCare (SC)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC San Diego

La Jolla, California, 92093, United States

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 2, 2017

Study Start

September 1, 2013

Primary Completion

January 1, 2020

Study Completion

June 1, 2020

Last Updated

May 25, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations