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.
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
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.
- Conditions
- Child Maltreatment
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Model Care |
| Standard Care | No intervention | PCPs 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.
Parent to Child Conflict Tactics Scale
Measured: Initial contact, 6 months & 12 months after start of study participation
Secondary outcomes (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.
- First posted9 Jan 2009 (estimated)
- Study startMay 2006
- Primary completionMar 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MaltreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Doris Duke Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Howard Dubowitz, MD MS, Principal investigator, University of Maryland
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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Child Maltreatment: A Role for Community Pediatricians
- ClinicalTrials.gov ID
- NCT00819702
- Acronym / sponsor ID
- SEEK / HP-00040157 (H-27327)
- Conditions
- Child Maltreatment
- Keywords
- child abuse prevention, primary care, professional education in primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 905 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Doris Duke Charitable Foundation
- Study start
- May 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 9 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Model Care | Experimental | Other: Model CareThe 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. |
| Standard Care | No intervention | –PCPs in Standard Care group served as the controls. They continued to practice as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Model CareThe Model Care provided training to pediatric health care providers to assess parental psychosocial risk factors to child maltreatment. | Other | Model Care |
Primary outcome
Parent to Child Conflict Tactics Scale
Time frame: Initial contact, 6 months & 12 months after start of study participation
1 secondary outcome
Department of Human Services, Department of Child Protection records.
Time frame: Child's birth through March 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Dubowitz, MD MS principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
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.