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Child MaltreatmentSEEKNCT00819702

A Safe Environment for Every Kid (SEEK): A Model for Primary Care

A study testing Model Care in people with Child Maltreatment, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Child Maltreatment
What is being tested?
Model Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
905 participants
Where
1 siteUnited States
Study dates
May 2006to May 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Maryland, School of Medicine

    Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: Preventing Child Maltreatment: A Role for Community Pediatricians

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.

Read the detailed description

The SEEK project, funded by a CDC grant to the Division of Child Protection at the University of Maryland School of Medicine, attempts to offer a comprehensive and practical office-based approach to the identification and assessment of risk factors for child maltreatment, integrated into the delivery of well child health care.

Review of the literature identifies four major risk factors leading to child maltreatment, 1) maternal depression, 2) alcohol and substance abuse, 3) domestic violence, and 4) parental stress and poor coping. The project has several "arms" to address these risk factors. Initially, there is training to help busy primary care providers (PCPs) address the targeted problems in the pediatric office setting. The second phase is the introduction of a brief screening questionnaire into selected well child visits to identify these risk factors in families. If risk factors are present, the PCP will briefly assess the problem. A project social worker is available (by phone or in the office) to help address the problem, and to aid the families in accessing community resources. Another part of the project assesses the validity of the screening questionnaire against several "gold standard" measures used to diagnose the targeted risk problems.

The training focused on the four major factors described. We used realistic office scenarios and offered participants the opportunity to use newly learned management strategies in addressing them. Small group experience with adequate time for processing and practice were utilized. Scheduling was done in conjunction with the participating offices. An advisory committee of practicing community pediatricians and office personnel offered consultation on all phases of the program, as well as strategies to efficiently integrate the program into office practice. The project enlisted 102 PCPs in 18 practices with half serving as controls. Those in the intervention arm received the training. Study health care offices used the one-page SEEK screening questionnaire in their practices. Control pediatricians made no change to their current practice, and continued to provide standard care. Parents were given the questionnaire, in the office, before the 2 and 15 month, and 2, 3, 4, and 5 year well child visits. Questionnaires were completed while the parent waited. Questionnaires were quickly and easily read by the PCPat the visit. Significant issues were briefly assessed and addressed during the visit. The project social worker was available to practices for consultation and for direct intervention with families. "Booster sessions," reviewing the educational and intervention materials were held four times during the 2.5 year study period. PCP knowledge, attitudes, level of comfort and perceived competence regarding the targeted problems were assessed at the beginning and end of the training and at the end of the 2nd and 3rd year.

The central objective of the SEEK project was to examine whether parent functioning was improved by addressing common risk factors for child maltreatment, thus strengthening families and helping prevent maltreatment. A subset of parents in the project practices - intervention and control - were approached to participate in the evaluation of the project. Interest in participating was briefly assessed in the practice. A member of the project team contacted interested parents to fully explain what is involved. Parents who agreed to participate completed a survey (on-line or paper) at three different points. Survey completion took about 60 minutes, for which they were modestly compensated.

In addition, to evaluate the project, members of the project team did a chart review, and directly observed practice behavior. We also asked parents' permission to review Department of Social Services records for possible involvement. All participating pediatricians and practices were invited to share in the conclusions at the end of the project.

The SEEK team hopes that this intervention will be the basis for a new and practical approach to the assessment of serious psychosocial risk factors within the framework of health supervision visits. Ultimately, our hope is that the identification and amelioration of these risk factors will help prevent child maltreatment, and improve the lives of many children and their families. We encourage you to join us in developing an innovative approach to help address psychosocial risk factors in pediatric practice.

Being tested
Model Care
Keywords
child abuse prevention, primary care, professional education in primary care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Model CareOther

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

Study groups in NCT00819702
Study groupRoleWhat they receive
Model CareExperimentalThe 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.
Receives: Other: Model Care
Standard CareNo interventionPCPs in Standard Care group served as the controls. They continued to practice as usual.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parent to Child Conflict Tactics Scale

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

Secondary outcomes (1)
  1. Department of Human Services, Department of Child Protection records.

    Measured: Child's birth through March 2009

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2009 (estimated)
  2. Study startMay 2006
  3. Primary completionMar 2009
  4. Study completionMay 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
905 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00819702
Sponsor's protocol ID
HP-00040157 (H-27327)
Other IDs
1R49CE000588
Acronym
SEEK
Status last verified
Nov 2019
First submitted
7 Jan 2009
Last updated
8 May 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Model Care in people with Child Maltreatment, run by University of Maryland, Baltimore at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parent to Child Conflict Tactics Scale (time frame: Initial contact, 6 months & 12 months after start of study participation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.

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