NCT03642327

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

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

First Submitted

Initial submission to the registry

August 1, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

March 15, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 29, 2025

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

5 years

First QC Date

August 1, 2018

Results QC Date

February 21, 2025

Last Update Submit

May 9, 2025

Conditions

Keywords

Child Abuse PreventionPrimary CareProfessional Education in Primary Care

Outcome Measures

Primary Outcomes (3)

  • Stages of SEEK Implementation Completion (SIC) - Startup (at a Practice Level)

    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)

    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

    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 Outcomes (20)

  • Overall Rates of Children With Possible Abuse and Neglect.

    2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.

  • Rates of Children With Possible Neglect.

    2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.

  • Rates of Children With Non-adherence to Medical Care

    2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.

  • Rates of Under Immunized Children

    2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.

  • Rates of Children With Possible Abuse.

    2 years prior to implementing SEEK, 2 years after implementing SEEK., 48 months total.

  • +15 more secondary outcomes

Study Arms (2)

Independent online training (IND)

ACTIVE COMPARATOR

IND refers to practitioners Independently doing the online training.

Other: Independent online training (IND)

Maintenance of Certification (MOC)

EXPERIMENTAL

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)

Interventions

MOC training will lead to more positive attitudes, comfort level and competence in addressing risk factors for Child Maltreatment.

Maintenance of Certification (MOC)

IND refers to practitioners Independently doing the online training.

Independent online training (IND)

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Related Publications (4)

  • Dubowitz H, Belanger R, Magder L, Palinkas LA, Kim H, Muralidharan V. Comparing 2 Training Modalities Supporting the Adoption of the Safe Environment for Every Kid Approach in Pediatric Primary Care. Acad Pediatr. 2025 Jan-Feb;25(1):102534. doi: 10.1016/j.acap.2024.07.001. Epub 2024 Jul 14.

    PMID: 39004298BACKGROUND
  • Dubowitz H, Finkelhor D, Zolotor A, Kleven J, Davis N. Addressing Adverse Childhood Experiences in Primary Care: Challenges and Considerations. Pediatrics. 2022 Apr 1;149(4):e2021052641. doi: 10.1542/peds.2021-052641.

    PMID: 35362065BACKGROUND
  • Dubowitz H, Saldana L, Magder LA, Palinkas LA, Landsverk JA, Belanger RL, Nwosu US. Protocol for comparing two training approaches for primary care professionals implementing the Safe Environment for Every Kid (SEEK) model. Implement Sci Commun. 2020 Sep 22;1:78. doi: 10.1186/s43058-020-00059-9. eCollection 2020.

    PMID: 32974614BACKGROUND
  • Palinkas LA, Belanger R, Newton S, Saldana L, Landsverk J, Dubowitz H. Assessment of Adoption and Early Implementation Barriers and Facilitators of the Safe Environment for Every Kid (SEEK) Model. Acad Pediatr. 2023 Sep-Oct;23(7):1434-1445. doi: 10.1016/j.acap.2023.06.024. Epub 2023 Jun 22.

    PMID: 37354951BACKGROUND

Limitations and Caveats

The Covid pandemic affected practices and personnel and consequently the study. The sample is relatively small. ICD-codes from EHR data are a limited proxy for possible child abuse and neglect.

Results Point of Contact

Title
Howard Dubowitz, MD, Professor of Pediatrics
Organization
University of Maryland School of Medicine

Study Officials

  • Howard Dubowitz, MD, MD

    University of Maryland, Baltimore

    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
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

August 1, 2018

First Posted

August 22, 2018

Study Start

March 15, 2019

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

May 29, 2025

Results First Posted

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations