NCT00819702

Brief Summary

Our broad goal is to help prevent child maltreatment (CM) by modifying pediatric practice to be more responsive to prevalent psychosocial needs of many children and families.Training pediatricians to address key risk factors for CM, the Safe Environment for Every Kid (SEEK) model aims to support parenting and family functioning, reducing the risk for CM while helping promote children's health, development and safety. We are building upon the existing pediatric primary care system and strengthening the training of pediatricians. The project also builds on our extensive research and clinical expertise in CM and in prevention (Black \& Dubowitz, 1999, Dubowitz et al., 1998, 1999, in press; Dubowitz \& Guterman, 2005, Gaudin \& Dubowitz, 1997). We have developed and implemented an enhanced model of pediatric primary care, taking advantage of the enormous opportunities of the existing pediatric primary care system, with its regular contact with young children and parents (Dubowitz \& Newberger, 1989; Dubowitz, 1989, 1990; Green, 1994). Pediatricians typically devote over half their time to checkups, focusing on prevention. There is increasing recognition that pediatric care must incorporate aspects of parental and family functioning and collaborate with community resources (Academy of Pediatrics, 1998; Green, 1994b). The broad goal of this project is to implement concepts that have been embraced by the field of pediatrics, but have not been applied and tested.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
905

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 8, 2023

Status Verified

November 1, 2019

Enrollment Period

2.8 years

First QC Date

January 7, 2009

Last Update Submit

May 4, 2023

Conditions

Keywords

child abuse preventionprimary careprofessional education in primary care

Outcome Measures

Primary Outcomes (1)

  • Parent to Child Conflict Tactics Scale

    Initial contact, 6 months & 12 months after start of study participation

Secondary Outcomes (1)

  • Department of Human Services, Department of Child Protection records.

    Child's birth through March 2009

Study Arms (2)

Model Care

EXPERIMENTAL

The Model Care approach was implemented in 7 practices, where PCPs were trained to address major risk factors for CM, including maternal depression, alcohol/substance abuse, intimate partner violence, food insecurity, harsh punishment and major stress. We taught how they can be briefly assessed and initially addressed. The initial training consisted of one 4-hour in-person session. Use of the Parent Screening Questionnaire (PSQ) was discussed, as was the importance of applying it universally during regular checkups. PCPs SEEK Parent Handouts on each targeted problem. We held 1-hour booster sessions every 6 months over the subsequent 2.5 years.

Other: Model Care

Standard Care

NO INTERVENTION

PCPs in Standard Care group served as the controls. They continued to practice as usual.

Interventions

The Model Care provided training to pediatric health care providers to assess parental psychosocial risk factors to child maltreatment.

Model Care

Eligibility Criteria

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

You may qualify if:

  • Mother or mother figure accompanying a child under 6 for a regular checkup.
  • Fluent english
  • Mother agrees to participate
  • Health Care provider is provider at involved practice
  • Health Care provider agrees to participate

You may not qualify if:

  • Mother is already participating through another child
  • Mother does not speak english
  • Mother declines participation
  • Health Care providers practice is not involved in study
  • Health Care provider declines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland, School of Medicine

Baltimore, Maryland, 21201, United States

Location

Study Officials

  • Howard Dubowitz, MD MS

    University of Maryland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2009

First Posted

January 9, 2009

Study Start

May 1, 2006

Primary Completion

March 1, 2009

Study Completion

May 1, 2010

Last Updated

May 8, 2023

Record last verified: 2019-11

Locations