NCT01791777

Brief Summary

The proposed study will compare purveyor coaching (conducted by National SafeCare Training and Research Center (NSTRC)) to local coaching that is supported by the purveyor (NSTRC). The outcomes of interest are home visitor fidelity and competence with the SafeCare model, and family engagement and skill acquisition. The study will also include a rigorous cost effectiveness analysis, and will examine individual and organizational factors that may affect implementation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

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, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

2.9 years

First QC Date

January 15, 2013

Last Update Submit

February 21, 2019

Conditions

Keywords

fidelityimplementation sciencecompetencetrainingcoaching

Outcome Measures

Primary Outcomes (2)

  • Change in provider fidelity on the Home Visitor Fidelity Checklist.

    As consistent with typical SafeCare implementation, the Home Visitors who provide the parent-training curriculum, SafeCare, to their clients will be monitored by a supervisor, their Coach, monthly to ensure fidelity to the SafeCare model is met. The Coach will listen to an audio recording the Home Visitor records of a session they have implementing SafeCare with their client and will grade the Home Visitor's performance using the Home Visitor Fidelity Checklist. The audio recording of the SafeCare session, the Coach's graded checklist of the session, as well as an audio recording the Coach captures of their feedback to the Home Visitor of the session and their checklist score will be captured every month.

    Home Visitors will be monitored for the duration it takes up to five of their clients, who are also consented to participate in the study, to complete the SafeCare parent-training curriculum, an expected average of 6 months.

  • Change in provider competency on the Home Visitor Competency Scale.

    As consistent with typical SafeCare implementation, the Home Visitors who provide the parent-training curriculum, SafeCare, to their clients will be monitored by a supervisor, their Coach, monthly to ensure fidelity to the SafeCare model is met. The Coach will listen to an audio recording the Home Visitor records of a session they have implementing SafeCare with their client and will grade the Home Visitor's performance using the Home Visitor Fidelity Checklist. The audio recording of the SafeCare session, the Coach's graded checklist of the session, as well as an audio recording the Coach captures of their feedback to the Home Visitor of the session and their checklist score will be captured every month for purposes of fidelity monitoring. Blind coders will listen to the SafeCare sessions captured each month and score them using the Home Visitor Competency Scale.

    Home Visitors will be monitored for the duration it takes up to five of their clients, who are also consented to participate in the study, to complete the SafeCare parent-training curriculum, an expected average of 6 months.

Secondary Outcomes (2)

  • Time spent performing SafeCare coaching duties as recorded on the Time Diary form.

    Coaches will record their time spent performing SafeCare coaching for the duration it takes up to five of their Home Visitor's clients to complete the SafeCare parent-training curriculum, an expected average of 6 months.

  • Change in performance of parenting skills taught in the SafeCare parent-training program.

    Time it takes SafeCare clients to complete the SafeCare parenting-training curriculum, approximately 4-6 months.

Study Arms (2)

Purveyor

EXPERIMENTAL

The "purveyor" arm will include SafeCare Coaching that is conducted by a Training Specialists from the National SafeCare Training and Research Center (NSTRC), a GSU (Georgia State University)-Center that conducts training and research on the SafeCare model.

Behavioral: SafeCare Coaching

Local

EXPERIMENTAL

The the "local" are will receive SafeCare Coaching that is provided by a staff member who works for the local social service agency.

Behavioral: SafeCare Coaching

Interventions

This study involves a comparison of different coaching models for providers who are newly trained to conduct an evidence-based parent training program (SafeCare). As part of all SafeCare trainings, all providers receive workshop training plus ongoing coaching to promote adherence to the intervention model. This research is aimed at understanding the coaching aspect of the training and dissemination processes, with the goal of implementing the most effective and efficient dissemination processes. One group of home visitors will be coached directly by NSTRC trainers, who work for NSTRC. The other group of home visitors will receive coaching that is provided by a staff member who works for the local social service agency.

LocalPurveyor

Eligibility Criteria

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

You may qualify if:

  • Providers administering SafeCare (Home Visitors and Coaches).
  • Parents receiving SafeCare services from a Home Visitor how is also participating in the study.

You may not qualify if:

  • Individuals under the age of 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Parent Aid Child Abuse Prevention Center

Tucson, Arizona, 85713, United States

Location

County of Humboldt - Department of Health and Human Services

Eureka, California, 95501, United States

Location

Family Support Services of North Florida Inc.

Jacksonville, Florida, 32207, United States

Location

Georiga State University

Atlanta, Georgia, 30303, United States

Location

The Listening Ear

Conyers, Georgia, 30013, United States

Location

Pathways Transitions Programs

Decatur, Georgia, 30030, United States

Location

Children's Center of Surry, Inc.

Dobson, North Carolina, 27017, United States

Location

Exchange Club of Durham North Carolina

Durham, North Carolina, 27707, United States

Location

Buckner Children & Family Services, Inc.

Amarillo, Texas, 79117, United States

Location

Children's Connections, Inc.

Lubbock, Texas, 79423, United States

Location

Study Officials

  • Daniel J Whitaker, PhD

    Georgia State Univeristy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, National SafeCare Training and Research Center

Study Record Dates

First Submitted

January 15, 2013

First Posted

February 15, 2013

Study Start

September 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

February 25, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

There is not a plan to make individual participant data available.

Locations