Study 12 of 420 for search of: received on or after 12/30/2008
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A Safe Environment for Every Kid (SEEK II)
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: University of Maryland
Doris Duke Charitable Foundation
Information provided by: University of Maryland
ClinicalTrials.gov Identifier: NCT00819702
  Purpose

Our broad goal is to help prevent child maltreatment (CM) by modifying pediatric practice to be more responsive to important biopsychosocial needs of many children and families. Training pediatricians to address key risk factors for CM, thereby enhancing parenting and family functioning, reducing the risk for CM while helping ensure children's health and safety, are accomplishing this. We are building upon the existing pediatric primary care system and strengthen 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.


Condition Intervention
Child Maltreatment
Other: Model Care

U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment, Efficacy Study
Official Title: Preventing Child Maltreatment: A Role for Community Pediatricians

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Parent to Child Conflict Tactics Scale [ Time Frame: Initial contact, 6 months & 12 months after start of study participation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Department of Human Services, Department of Child Protection records. [ Time Frame: Child's birth through March 2009 ] [ Designated as safety issue: Yes ]

Enrollment: 1234
Study Start Date: May 2006
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Model Care: Experimental
The Model Care approach was implemented in 7 practices, where health care providers were specially trained to address major risk factors for CM, including maternal depression, alcohol and substance abuse, intimate partner violence, harsh discipline, and stress. We taught the relevance of these problems for children's health and safety, and how they can be briefly assessed and initially addressed. The initial training consisted of 2 four hour session. The use of the Parent Screening Questionnaire (PSQ) was discussed, including the importance of applying it universally during regular checkups, on a set schedule. The health care providers received laminated cards or an electronic version for a PDA with the salient information a handbook with more complete practical information including local resources, and user friendly parent hand outs on each of the targeted issues. We held one hour booster sessions at 4 to 6 months.
Other: Model Care
The Model Care provides training to pediatric health care providers to assess parental psychosocial risk factors to child maltreatment.
Standard Care: No Intervention
Health Care providers in Standard Care group will serve as the controls. They will continue to practice as usual.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819702

Locations
United States, Maryland
University of Maryland, School of Medicine
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Doris Duke Charitable Foundation
Investigators
Principal Investigator: Howard Dubowitz, MD MS University of Maryland
Study Director: Angela M Grodack, MA University of Maryland
  More Information

Responsible Party: University of Maryland, School of Medicine, Division of Child Protection ( Howard Dubowitz, MD MS )
Study ID Numbers: HP-00040157 (H-27327), 1R49CE000588
Study First Received: January 7, 2009
Last Updated: January 7, 2009
ClinicalTrials.gov Identifier: NCT00819702  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
child abuse prevention
primary care
professional education in primary care

ClinicalTrials.gov processed this record on January 13, 2009