ClinicalTrials.gg
CompletedNCT01791777Updated Feb 25, 2019

Effectiveness and Cost-effectiveness of Coaching Models to Promote Implementation of an Evidence-based Parenting Program

An interventional study of SafeCare Coaching in Child Maltreatment, sponsored by Georgia State University. Completed at 10 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-25.

Sponsored by Georgia State University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
147
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This study is being conducted in the context of a nationwide implementation of SafeCare, an evidence-based parent training program. The primary goal of the research is to examine methods of coaching newly trained providers to implement a specific evidence-based practice. Thus, in this study, we are examining how two different coaching models affect provider fidelity and competence and parent's acquisition of the skills being trained. The primary participants in this study are the local coaches that will provide coaching to home visitors, the home visitors that will provide SafeCare to parents and the parents who will receive the SafeCare model. A total of 20 coaches, 90 home visitors and 270 parents have been proposed to participate in the study (n=380). The nature of participation in the study is similar for coaches and home visitors, but somewhat different for parents. Both groups will be asked to complete a variety of questionnaires at different time points, and allow observation of their performance with SafeCare delivery (for home visitors) and fidelity monitoring and coaching (for coaches). Observations may be done live or via audio recording. Parent participants will already be enrolled in SafeCare services, a voluntary parent-training program for parents, and will be invited to participate in this study by their home visitor. Parents' participation will involve completing a baseline and post-treatment in-home assessment before and after the SafeCare program, respectively. Each assessment will include an audio-computer assisted self-interview (ACASi), and an assessment of SafeCare skills. Parents will also complete 4 brief telephone interviews to assess their satisfaction and engagement with SafeCare services and provider competence. A more detailed list of data collection for coaches, home visitors, and trainers is as follows: Coaches: (1) prior to training/implementation, complete survey of individual and organizational variables that relate to implementation (2) allow observations of fidelity monitoring and coaching (3) report on home visitor competence, perceived self-competence, and support received from trainer (once per month for 6 months) (4) complete weekly time diaries reporting on time spent coaching (weekly for 6 months); Home visitors (1) prior to training/implementation, complete survey of individual and organizational variables that relate to implementation (2) allow and submit observations of SafeCare implementation (3) report on coach competence and support received from coach and perceived self-competence (once per month for 6 months); Families (1) complete baseline and post-treatment assessment involving behavioral observations and survey completed via ACASI (2) complete four short telephone interview reporting on home visitor competence and satisfaction with services.

02

Conditions studied

  • Child Maltreatment

Keywords

  • fidelity
  • implementation science
  • competence
  • training
  • coaching
03

In context

Lead sponsor

Georgia State University is the lead sponsor of 56 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Individuals under the age of 18.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
147 participants (actual)

Study arms

  • Experimental
    Purveyor

    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

  • Experimental
    Local

    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

  • BehavioralSafeCare Coaching

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

  2. 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.

    Time frame: 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

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

    SafeCare Coaches will record the time they spend performing SafeCare coaching duties every week on the Time Diary form. The form allows them to specify the date, number of minutes, content, and participating staff involved in each SafeCare activity they perform within the last week. Up to 26 weeks of Time Diaries will be collected to encompass the approximate 6-month study period.

    Time frame: 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.

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

    Clients participating in the SafeCare parent-training curriculum will meet with their Home Visitors once a week for 18-20weeks and will be taught skills related to parent-child interactions, home safety, and identification and treatment of common child-illnesses. Home Visitors will assess client's use of the parenting skills before, during, and after the skills are taught to them; documents used to assess these skills will be collected by the research team. In addition, clients who participate in the study will complete two in-home assessments, once before starting the SafeCare program and once after completing the SafeCare program) which will involve data collection related to the three skill areas of SafeCare. Both the assessment documents collected by the Home Visitor during typical implementation as well as the data collected during the two in-home assessments will be used to determine the change in performance of clients who participate in the SafeCare parent-training program.

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

07

Study locations

10 sites
  • Parent Aid Child Abuse Prevention Center
    Tucson, Arizona 85713, United States
  • County of Humboldt - Department of Health and Human Services
    Eureka, California 95501, United States
  • Family Support Services of North Florida Inc.
    Jacksonville, Florida 32207, United States
  • Georiga State University
    Atlanta, Georgia 30303, United States
  • The Listening Ear
    Conyers, Georgia 30013, United States
  • Pathways Transitions Programs
    Decatur, Georgia 30030, United States
  • Children's Center of Surry, Inc.
    Dobson, North Carolina 27017, United States
  • Exchange Club of Durham North Carolina
    Durham, North Carolina 27707, United States
  • Buckner Children & Family Services, Inc.
    Amarillo, Texas 79117, United States
  • Children's Connections, Inc.
    Lubbock, Texas 79423, United States
08

References and documents

Individual participant data

Plan to share: No — There is not a plan to make individual participant data available.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01791777
Lead sponsor
Georgia State University
Collaborators
Centers for Disease Control and Prevention, University of Georgia
Responsible party
Daniel Whitaker (Director, National SafeCare Training and Research Center, Georgia State University) — Principal investigator
First posted
Feb 15, 2013
Start date
Sep 2010
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Feb 25, 2019

Study contacts

Daniel J Whitaker, PhD
principal investigator · Georgia State Univeristy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion