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

February 21, 2019 updated by: Daniel Whitaker, Georgia State University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
147

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

  • Individuals under the age of 18.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in provider fidelity on the Home Visitor Fidelity Checklist.
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.
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.
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time spent performing SafeCare coaching duties as recorded on the Time Diary form.
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.
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.
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 Frame: Time it takes SafeCare clients to complete the SafeCare parenting-training curriculum, approximately 4-6 months.
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 it takes SafeCare clients to complete the SafeCare parenting-training curriculum, approximately 4-6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Georgia State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention
University of Georgia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel J Whitaker, PhD, Georgia State Univeristy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R18CE001733 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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