Child AbuseSEEKNCT00507299
A Safe Environment for Every Kid (SEEK) I
A study testing Enhanced pediatric primary care and Standard pediatric primary care in people with Child Abuse, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This study aims to enhance pediatric primary care to make it more responsive to psychosocial needs facing many families. We hypothesized that by identifying and addressing certain problems, such as depressed mothers, parental drug use, and domestic violence, we would help decrease child abuse and neglect. Read more about this study
- Who is it for?
- Ages 1 month to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Abuse
- What is being tested?
- Enhanced pediatric primary care and Standard pediatric primary care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to 31 Dec 2006
- 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 1 month to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Child 0 - 5 years
- Family English speaking
- Parent agrees to participate
Who cannot join
- Child in foster care
- Another child in the family already enrolled
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore
Baltimore, Maryland, 21201
About this study
Official title: A Safe Environment for Every Kid (SEEK) I: Preventing Child Maltreatment - A Role for Pediatrics
This study aims to enhance pediatric primary care to make it more responsive to psychosocial needs facing many families. We hypothesized that by identifying and addressing certain problems, such as depressed mothers, parental drug use, and domestic violence, we would help decrease child abuse and neglect.
Read the detailed description
This study aims to enhance pediatric primary care to make it more responsive to psychosocial needs facing many families. We hypothesized that by identifying and addressing certain problems, such as depressed mothers, parental drug use, and domestic violence, we would help decrease child abuse and neglect.
The first step was to train pediatric residents on the importance of addressing the targeted problems. Then, we developed a brief screening tool to use when children under six years came in for the regular checkups. Parents would complete this while waiting for their doctor. Finally, the doctor and/or social worker would try address any problems the parent identified.
- Conditions
- Child Abuse
- Being tested
- Enhanced pediatric primary care, Standard pediatric primary care
- Keywords
- Child maltreatment, Physician education, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced pediatric primary careBehavioural
Residents received special training to address targeted psychosocial problems. Parents bringing in children (0 - 5 years) completed a screening questionnaire and gave this to their doctor. The resident briefly assessed the identified problems and helped address them. A social worker was present to assist.
Standard pediatric primary careBehavioural
Residents did not receive special training on the targeted psychosocial problems. They did not use the parent screening questionnaire, and they did not have a dedicated social worker.
| Study group | Role | What they receive |
|---|---|---|
| Model Care (SEEK) | Experimental | Residents in this group received special training on addressing pyschosocial problems. They then used a parent screening questionnaire, and addressed identified problems. A study social worker was also part of this intervention. Thus, this group provided enhanced pediatric primary care. Receives: Behavioral: Enhanced pediatric primary care |
| Standard pediatric primary care | Active comparator | This arm involved residents receiving the regular education through the program. They did not use the screening questionnaire to identify psychosocial problems, and did not have a dedicated social worker to assist them. Instead, residents in this group provided standard pediatric primary care Receives: Behavioral: Standard pediatric primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced child abuse and neglect
Reports to Child Protective Services
Measured: 2002 - 2005
Secondary outcomes (1)
Improved resident attitudes and behavior regarding psychosocial problems.
Self-reported thinking and behavior regarding addressing targeted problems
Measured: 2002 - 2005
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2007 (estimated)
- Study startJun 2002
- Primary completion31 Dec 2005
- Study completion31 Dec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child AbuseStudies 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
- Single group
- Model description
- Pediatric residents were trained to screen for and help address prevalent psychosocial problems, such as parental depression and substance abuse, that are risk factors for child maltreatment (CM). The SEEK model included a project social worker and use of community resources.
- Masking
- None (open label)
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howard Dubowitz, University of Maryland, Baltimore
- Investigators
- Howard Dubowitz, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507299
- Sponsor's protocol ID
- H-20890
- Acronym
- SEEK
- Status last verified
- Nov 2019
- First submitted
- 25 Jul 2007
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Dubowitz H, Feigelman S, Lane W, Prescott L, Blackman K, Grube L, Meyer W, Tracy JK. Screening for depression in an urban pediatric primary care clinic. Pediatrics. 2007 Mar;119(3):435-43. doi: 10.1542/peds.2006-2010.
PubMed 17332195Kalra N, Hooker L, Reisenhofer S, Di Tanna GL, Garcia-Moreno C. Training healthcare providers to respond to intimate partner violence against women. Cochrane Database Syst Rev. 2021 May 31;5(5):CD012423. doi: 10.1002/14651858.CD012423.pub2.
PubMed 34057734Feigelman S, Dubowitz H, Lane W, Grube L, Kim J. Training pediatric residents in a primary care clinic to help address psychosocial problems and prevent child maltreatment. Acad Pediatr. 2011 Nov-Dec;11(6):474-80. doi: 10.1016/j.acap.2011.07.005. Epub 2011 Sep 29.
PubMed 21959095
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safe Environment for Every Kid (SEEK) I: Preventing Child Maltreatment - A Role for Pediatrics
- ClinicalTrials.gov ID
- NCT00507299
- Acronym / sponsor ID
- SEEK / H-20890
- Conditions
- Child Abuse
- Keywords
- Child maltreatment, Physician education, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jun 2002 (actual)
- Primary completion
- 31 Dec 2005 (actual)
- Study completion
- 31 Dec 2006 (actual)
- First posted
- 26 Jul 2007 (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.
This study aims to enhance pediatric primary care to make it more responsive to psychosocial needs facing many families. We hypothesized that by identifying and addressing certain problems, such as depressed mothers, parental drug use, and domestic violence, we would help decrease child abuse and neglect.
Detailed description
This study aims to enhance pediatric primary care to make it more responsive to psychosocial needs facing many families. We hypothesized that by identifying and addressing certain problems, such as depressed mothers, parental drug use, and domestic violence, we would help decrease child abuse and neglect.
The first step was to train pediatric residents on the importance of addressing the targeted problems. Then, we developed a brief screening tool to use when children under six years came in for the regular checkups. Parents would complete this while waiting for their doctor. Finally, the doctor and/or social worker would try address any problems the parent identified.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pediatric residents were trained to screen for and help address prevalent psychosocial problems, such as parental depression and substance abuse, that are risk factors for child maltreatment (CM). The SEEK model included a project social worker and use of community resources.
| Arm | Type | Receives |
|---|---|---|
| Model Care (SEEK) | Experimental | Behavioral: Enhanced pediatric primary careResidents in this group received special training on addressing pyschosocial problems. They then used a parent screening questionnaire, and addressed identified problems. A study social worker was also part of this intervention. Thus, this group provided enhanced pediatric primary care. |
| Standard pediatric primary care | Active comparator | Behavioral: Standard pediatric primary careThis arm involved residents receiving the regular education through the program. They did not use the screening questionnaire to identify psychosocial problems, and did not have a dedicated social worker to assist them. Instead, residents in this group provided standard pediatric primary care |
Who may qualify
- Ages
- 1 month to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Child 0 - 5 years
- Family English speaking
- Parent agrees to participate
Key exclusion criteria (2 listed)
- Child in foster care
- Another child in the family already enrolled
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 |
|---|---|---|
| Enhanced pediatric primary careResidents received special training to address targeted psychosocial problems. Parents bringing in children (0 - 5 years) completed a screening questionnaire and gave this to their doctor. The resident briefly assessed the identified problems and helped address them. A social worker was present to assist. | Behavioural | Model Care (SEEK) |
| Standard pediatric primary careResidents did not receive special training on the targeted psychosocial problems. They did not use the parent screening questionnaire, and they did not have a dedicated social worker. | Behavioural | Standard pediatric primary care |
Primary outcome
Reduced child abuse and neglect
Time frame: 2002 - 2005
Reports to Child Protective Services
1 secondary outcome
Improved resident attitudes and behavior regarding psychosocial problems.
Time frame: 2002 - 2005
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 7 Apr 2022.
- Results publication: PubMed 17332195Dubowitz H, Feigelman S, Lane W, Prescott L, Blackman K, Grube L, Meyer W, Tracy JK. Screening for depression in an urban pediatric primary care clinic. Pediatrics. 2007 Mar;119(3):435-43. doi: 10.1542/peds.2006-2010.
- Derived from this study: PubMed 34057734Kalra N, Hooker L, Reisenhofer S, Di Tanna GL, Garcia-Moreno C. Training healthcare providers to respond to intimate partner violence against women. Cochrane Database Syst Rev. 2021 May 31;5(5):CD012423. doi: 10.1002/14651858.CD012423.pub2.
- Derived from this study: PubMed 21959095Feigelman S, Dubowitz H, Lane W, Grube L, Kim J. Training pediatric residents in a primary care clinic to help address psychosocial problems and prevent child maltreatment. Acad Pediatr. 2011 Nov-Dec;11(6):474-80. doi: 10.1016/j.acap.2011.07.005. Epub 2011 Sep 29.
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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 principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced pediatric primary care and Standard pediatric primary care in people with Child Abuse, 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 3 inclusion and 2 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 7 Apr 2022. 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?
Reduced child abuse and neglect (time frame: 2002 - 2005). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00507299, which also lists 3 linked publications.
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 7 Apr 2022.