SEEK: Dissemination and Implementation

May 9, 2025 updated by: Howard Dubowitz, University of Maryland, Baltimore

The Safe Environment for Every Kid (SEEK) Model: Dissemination and Implementation

This study aims to understand what influences the adoption and implementation of an innovative approach to pediatric primary care by medical professionals and staff providing that care. The innovation concerns addressing common psychosocial problems such as parental depression and substance abuse. Different approaches to training medical professionals will be examined as well as the use of software versus traditional 'paper and pencil' to facilitate 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

The proposed study, based on SEEK I and II findings is designed to study the effectiveness of technology driven training strategies to facilitate use of SEEK in helping prevent child maltreatment (CM) and its adoption and implementation in pediatric and family medicine settings. The implementation approach is anchored in four stages of the EPIS conceptual model: Exploration, adoption/Preparation, Implementation, and Sustainment. The strong evidence for SEEK's effectiveness has been underscored by its listing on the websites of the CDC, AHRQ, AAP, and by the California Clearinghouse for Evidence-Based Interventions in Child Welfare. Early adopters are increasingly implementing SEEK in primary care settings, including in Sweden. Four of the 5 healthcare systems in this proposal have implemented SEEK in some of their practices. However, practices within these systems operate independently of one another, and there should not be contamination among them. Each practice has its own lead physician, primary care providers (PCPs) and administrative staff and several have integrated behavioral health.

Design. The investigator selected a rigorous Hybrid Type III design which is an approach to examine implementation outcomes while also examining SEEK's effectiveness in preventing CM, measured by electron health record (EHR) indicators. Type III designs are facilitated by good EHR systems due to the low cost of data routinely gathered for clinical, services, and financial purposes. Five healthcare systems have committed to participating in the project, without committing individual practices and primary care providers (PCPs). Professionals, office staff and parents are nested within practices which are nested within the 5 participating healthcare systems. Practices will choose whether to participate, as will medical professionals within those practices. Participating practices will be randomized to one of the two training strategies for PCPs - Independent online training vs. a Maintenance of Certification (MOC) activity approved by the Boards of Pediatrics and of Family Physicians. Practices will be able to select the facilitation strategy (SEEKonline software or Traditional 'paper and pencil'). Participating professionals and staff within practices will need to adhere to the approach adopted by the practice. The design accounts for heterogeneity in geography, size of healthcare systems, type of primary care (pediatric and family medicine), and presence of integrated behavioral health. A small random sample of parents will be recruited from each practice.

For Aim 1, practices and PCPs will be randomized to one of the two training approaches. Using baseline and follow-up surveys, the investigators will assess the impact of each approach on PCPs' attitudes, knowledge, sense of competence, level of comfort and practice behavior with regard to addressing the targeted problems (e.g., parental depression).

Aim 2 focuses on the implementation of the SEEK model in pediatric and family medicine primary care practices. Practices will have the option of implementing the model using the SEEKonline software or the "traditional" paper and pencil approach. The evaluation involves measuring aspects of implementation such rates of adoption, fidelity to the model, and sustainment beyond the training. In addition, qualitative interviews will provide data regarding what facilitates or impedes optimal implementation.

For Aim 3, The investigators will assess the impact of the interventions on rates of child maltreatment (CM) based on ICD 10 diagnoses in EHRs. The investigators will include a cost-effectiveness analysis by estimating the costs associated with the different approaches to implementing SEEK.

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.
360

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore

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

Description

Inclusion Criteria:

  • Practice not already implementing the SEEK model.
  • The practice provides primary care to children.
  • The practice agrees to participate in the study.
  • PCPs, office staff and parents of children 0-5 years agree to participate.
  • Able to comprehend basic English
  • Access to a computer to complete online surveys.

Exclusion Criteria:

  • None

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
Active Comparator: Independent online training (IND)
IND refers to practitioners Independently doing the online training.
Other: Independent online training (IND)
IND refers to practitioners Independently doing the online training.
Experimental: Maintenance of Certification (MOC)
MOC involves a guided learning experience, approved by the American Board of Pediatrics and the American Board of Family Medicine for Maintenance of Certification credits. This involves a Quality Improvement project with 3 waves of data collection to assess and improve implementation while participating in 4 monthly webinars led by Dr. Dubowitz.
Behavioral: Experimental: Maintenance of Certification (MOC)
MOC training will lead to more positive attitudes, comfort level and competence in addressing risk factors for Child Maltreatment.

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
Stages of SEEK Implementation Completion (SIC) - Startup (at a Practice Level)
Time Frame: up to 30 months

The SIC is an assessment tool with 8 stages extending from Engagement to achievement of Competency. Each stage maps onto 3 phases of implementation (Pre-Implementation, Implementation and Sustainment).

Startup reflects whether the practice implemented SEEK - Yes/No. Yes = practice started implemented SEEK. Practices that did start are reported.
up to 30 months
Stages of Implementation Completion (SIC) - as Assessed by the Safe Environment for Every Kid (SEEK) Fidelity Score (at a Practice Level)
Time Frame: up to 30 months

The SIC is an assessment tool with 8 stages extending from Engagement to achievement of Fidelity. Each stage maps onto 3 phases of implementation (Pre-Implementation, Implementation and Sustainment).

Competence/Fidelity score reflects the extent to which a practice implemented the intervention as intended. Score range: 0-100; higher is better fidelity to the intervention as planned.
up to 30 months
Stages of SEEK Implementation Completion (SIC) - Sustainability
Time Frame: up to 30 months

The SIC is an assessment tool with 8 stages extending from Engagement to achievement of Competency. Each stage maps onto 3 phases of implementation (Pre-Implementation, Implementation and Sustainability).

Sustainability was determined if the practice was implementing SEEK 24 months after initiation and doing so with fidelity.

Reporting the number of practices that achieved sustainability.
up to 30 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
Overall Rates of Children With Possible Abuse and Neglect.
Time Frame: 2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.
International Classification of Diseases - 10 (ICD-10) codes related to possible child maltreatment (CM or child abuse and neglect) are readily accessible through EHRs. De-identified aggregate data were gathered towards the end of the study for all children in the practice 0-66 months of age.
2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.
Rates of Children With Possible Neglect.
Time Frame: 2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.
ICD-10 codes related to possible maltreatment (child abuse and neglect) are readily accessible through EHRs. De-identified aggregate data were gathered towards the end of the study for all children in the practice 0-66 months of age.
2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.
Rates of Children With Non-adherence to Medical Care
Time Frame: 2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.
ICD-10 codes related to possible maltreatment (child abuse and neglect) are readily accessible through EHRs. De-identified aggregate data were gathered towards the end of the study for all children in the practice 0-66 months of age.
2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.
Rates of Under Immunized Children
Time Frame: 2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.
ICD-10 codes related to possible maltreatment (child abuse and neglect) are readily accessible through EHRs. De-identified aggregate data were gathered towards the end of the study for all children in the practice 0-66 months of age.
2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.
Rates of Children With Possible Abuse.
Time Frame: 2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.
ICD-10 codes related to possible maltreatment (child abuse and neglect) are readily accessible through EHRs. De-identified aggregate data were gathered towards the end of the study for all children in the practice 0-66 months of age.
2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.
The Safe Environment for Every Kid (SEEK) PCP Questionnaire (PCPQ) - Addressing Depression Subscale
Time Frame: 30 months

The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence).

The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
30 months
SEEK PCP Questionnaire (PCPQ) - Addressing Food Insecurity
Time Frame: 30 months

The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence).

The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
30 months
SEEK PCP Questionnaire (PCPQ) - Addressing Major Stress
Time Frame: 30 months

The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence).

The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
30 months
SEEK PCP Questionnaire (PCPQ) - Addressing Intimate Partner Violence
Time Frame: 30 months

The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence).

The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
30 months
SEEK PCP Questionnaire (PCPQ) - Addressing Harsh Punishment
Time Frame: 30 months

The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence).

The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
30 months
SEEK PCP Questionnaire (PCPQ) - Addressing Substance Abuse
Time Frame: 30 months

The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence).

The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
30 months
SEEK PCP Questionnaire (PCPQ) - Attitudes Regarding Addressing Health-related Social Needs
Time Frame: 30 months

The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence).

The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
30 months
SEEK PCP Questionnaire (PCPQ) - Comfort Level Regarding Addressing Health-related Social Needs
Time Frame: 30 months

The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence).

The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
30 months
SEEK PCP Questionnaire (PCPQ) - Perceived Competence Regarding Addressing Health-related Social Needs
Time Frame: 30 months

The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence).

The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
30 months
SEEK PCP Questionnaire (PCPQ) - Knowledge Regarding Addressing Health-related Social Needs
Time Frame: 30 months

The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence).

The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
30 months
SEEK PCP Questionnaire (PCPQ) - Practice Behavior Regarding Addressing Health-related Social Needs
Time Frame: 30 months

The PCPQ, used in both SEEK RCTs has 5 vignettes, with 7-12 statements assessing PCPs' thinking and practice with regard to addressing the targeted CM risk factors. Items were grouped conceptually into 6 topical scales (e.g., Substance Abuse) and 5 cross-cutting themes (e.g., Perceived Competence).

The mean subscale scores ranged from 0-3. Higher scores reflect PCPs more optimal capability to address the problem.
30 months
SEEK Parent View of Relationship With Child's PCP Subscale - Adapted From the Patient-Doctor Interaction Scale
Time Frame: 24 months

Parents rate their child's PCP on this measure adapted for pediatric practice from the Patient-Doctor Interaction Scale. The Likert scale included 8 questions; the response set was from 1 (no) to 4 (always).

Subscale mean scores range from 1 - 4; higher scores indicate greater satisfaction.

The mean of the Likert subscale response is reported.
24 months
SEEK Parent View of the Attentiveness of the Child's PCP Subscale - Adapted From the Patient-Doctor Interaction Scale
Time Frame: 24 months

Parents rate their child's PCP on this measure adapted for pediatric practice from the Patient-Doctor Interaction Scale. The Likert scale included 8 questions; the response set was from 1 (no) to 4 (always).

Subscale mean scores range from 1 - 4; higher scores indicate greater satisfaction.

The mean of the Likert subscale response is reported.
24 months
SEEK Parent View of the Comprehensiveness of the Child's PCP Subscale - Adapted From the Patient-Doctor Interaction Scale
Time Frame: 24 months

Parents rate their child's PCP on this measure adapted for pediatric practice from the Patient-Doctor Interaction Scale. The Likert scale included 8 questions; the response set was from 1 (no) to 4 (always).

Subscale mean scores range from 1 - 4; higher scores indicate greater satisfaction.

The mean of the Likert subscale response is reported.
24 months
SEEK Parent View of the Communication Skills of the Child's PCP Subscale - Adapted From the Patient-Doctor Interaction Scale
Time Frame: 24 months

Parents rate their child's PCP on this measure adapted for pediatric practice from the Patient-Doctor Interaction Scale. The Likert scale included 8 questions; the response set was from 1 (no) to 4 (always).

Subscale mean scores range from 1 - 4; higher scores indicate greater satisfaction.

The mean of the Likert subscale response is reported.
24 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.
University of Maryland, Baltimore

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.
University of California, San Diego
Chestnut Health Systems

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: Howard Dubowitz, MD, MD, University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
March 15, 2019

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.
March 31, 2024

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.
March 31, 2024

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).
August 1, 2018

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.
August 20, 2018

First Posted (Actual)

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.
August 22, 2018

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.
May 29, 2025

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.
May 9, 2025

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.
May 1, 2025

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.
  • HP-00078770

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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