NCT02430337

Brief Summary

In this study, a computer-assisted adaptation of SafeCare, an evidence-based home visiting program, will be developed and tested in child welfare. This approach will assist home visitors with the delivery of SafeCare to families, with the goal of improving provider fidelity and implementation success. In the computer-assisted SafeCare sessions, a portion of the session will be delivered on a tablet computer that the home visitor brings to the family's home. The computer software will deliver the educational piece, or explain a piece of each session, along with modeling videos of the skills. The home visitor will follow up with the practice and feedback portions of the session. A randomized feasibility trial will be conducted to test the technology-based approach against the standard SafeCare implementation approach in terms of feasibility of implementation, provider job demands, and resources, as well as client outcomes such as skill acquisition and mental health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

January 22, 2020

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

April 2, 2015

Results QC Date

July 29, 2019

Last Update Submit

January 21, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Number of Providers Reporting Satisfaction With Technology

    The investigators examined provider qualitative feedback to count the number of participants reporting that the Technology-Assisted SafeCare was acceptable and feasible. Interview data was transcribed and summarized to examine themes reported by the Tech-Assisted SafeCare providers' at the time of their exit interview (approximately six months after the baseline assessment).

    Approximately six months after completing the baseline assessment

  • SafeCare Fidelity

    The SafeCare fidelity checklist measures 30+ clinical behaviors that SafeCare providers are expected to deliver during an hour long SafeCare session. Fidelity on each behavior is scored as a + if occurs and a - if does not occur. Percentages are computed for the number of +'s divided by the number of total behaviors. Scores range from 0 to 100%, with higher numbers indicating higher fidelity. A score of 85% or greater is indicative of high competence with SafeCare delivery. SafeCare providers receive fidelity monitoring for nine sessions (three in each of three modules) until they reach certification and once per month thereafter. All fidelity scores for the participants will be collected from baseline assessment to six-month follow-up in order to assess the effect of implementation condition on fidelity scores. The frequency of fidelity assessment will vary depending on the caseload of each home visitor participant.

    The average of up to 9 scores across 6 months

  • SafeCare Provider Implementation Status

    The investigators used 4 categories to indicate the status of the SafeCare providers at the end of their study participation, these groups: completed were workshop only, started SafeCare but became inactive, started and continued SafeCare active (but not certified), SafeCare certified (completed 9 family sessions with 85% fidelity)

    Status of provider at end of study participation

  • SafeCare Time Diary

    Provider participants documented their time spent on SafeCare session preparation, completion, and follow-up using a time diary. This form was used to document the time home visitors spend on job-related activities such as preparing for home visits, conducting home visits, and completing notes, among other activities. All participants completed the form following each SafeCare session they complete during the six months of the study. The total number of time diaries completed will vary depending on the home visitor's caseload. Means were computed based on an average of the time diaries submitted per study arm and wer compared for differences.

    average of provider time preparing for and completing SafeCare sessions during the study period (6 months)

Study Arms (2)

Technology-Assisted SafeCare

EXPERIMENTAL

A modified version of SafeCare, using a tablet and online program to complete a portion of the session

Behavioral: Technology-Assisted SafeCare

SafeCare-as-usual

ACTIVE COMPARATOR

SafeCare as it is usually delivered

Behavioral: SafeCare

Interventions

A technology-enhanced version of SafeCare

Also known as: SafeCareTech
Technology-Assisted SafeCare
SafeCareBEHAVIORAL

SafeCare, an evidence-based home visiting program

SafeCare-as-usual

Eligibility Criteria

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

You may qualify if:

  • Home Visitors: Home Visitors who are being trained in SafeCare
  • Parents: English-speaking SafeCare parents with a child between the ages of 1.5-5 years who are receiving services from a Home Visitor who is in this study

You may not qualify if:

  • Home Visitors: Home Visitors not being trained in SafeCare; Home Visitors who exclusively serve Spanish-speaking families
  • Parents: Parents not receiving SafeCare; parents whose Home Visitor is not a participant in this study; parents under age 18 or who have a child outside of the ages of 1.5-5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia State University, School of Public Health, National SafeCare Training & Research Center

Atlanta, Georgia, 30303, United States

Location

Related Publications (1)

  • Cowart-Osborne M, Jackson M, Chege E, Baker E, Whitaker D, Self-Brown S. Technology-Based Innovations in Child Maltreatment Prevention Programs: Examples from SafeCare(R). Soc Sci (Basel). 2014 Aug 15;3(3):427-440. doi: 10.3390/socsci3030427.

Limitations and Caveats

Small sample; limited power: fidelity \& certification; tablets provided: generalizability; assessment battery was limited-restricted data collected on potential implementation barriers; abbreviated study period; no family-level data.

Results Point of Contact

Title
Shannon Self Brown, PhD
Organization
Georgia State University

Study Officials

  • Shannon Self-Brown, PhD

    Georgia State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 2, 2015

First Posted

April 30, 2015

Study Start

April 1, 2013

Primary Completion

June 1, 2014

Study Completion

December 1, 2016

Last Updated

January 22, 2020

Results First Posted

January 22, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations