Low-income Children's Well-child Care VisitNCT00397644
Assisting Low-Income Families at Pediatric Well-Child Care Visits
A study testing Prompting (survey instrument/resources list) (behavior) in people with Low-income Children's Well-child Care Visit, run by Johns Hopkins University at 1 site in United States.
Trial summary
The objective of this study is to evaluate the impact and feasibility of a practice-based intervention on the discussion and referral of family psychosocial topics at well-child care visits at a medical home for low-income children. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Low-income Children's Well-child Care Visit
- What is being tested?
- Prompting (survey instrument/resources list) (behavior)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Caregivers of children aged 2 months to 10 years who present for well-child care visit at a pediatric clinic
Who cannot join
- Non-English speaking
- Foster parents
- Previously enrolled parent
- No access to telephone
Trial locations and contacts
1 site in 1 country.
United States1 site
Harriet Lane Clinic at Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
Official title: Enhancing a Medical Home for Vulnerable Children by Addressing Family Psychosocial Problems at Well-Child Care Visits: THE WE CARE Project
The objective of this study is to evaluate the impact and feasibility of a practice-based intervention on the discussion and referral of family psychosocial topics at well-child care visits at a medical home for low-income children.
Read the detailed description
Many low-income families have family psychosocial problems such as unemployment, housing difficulties, and food insecurity. Pediatric guidelines that pediatricians should be discussing and assisting these families. However, to date few routine do. The primary hypotheses for this study is that the WE CARE (Well-child care visit, Evaluation, Community resources, Advocacy, Referral, Education)intervention would increase the discussion and referral rates for family psychosocial problems at well-child care visits.
- Being tested
- Prompting (survey instrument/resources list) (behavior)
- Keywords
- pediatrician, well-child care visit, low-income children, family psychosocial problem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prompting (survey instrument/resources list) (behavior)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Discussion of family psychosocial problem
Referral of family psychosocial problem
Contacting community resources
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2006 (estimated)
- Study startMar 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low-income Children's Well-child Care VisitStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- The Commonwealth Fund
- Investigators
- Arvin Garg, MD, MPH, Principal investigator, Johns Hopkins School of MedicineJanet Serwint, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397644
- Sponsor's protocol ID
- 20060351
- Status last verified
- Oct 2023
- First submitted
- 7 Nov 2006
- Last updated
- 1 Nov 2023
- Results posted
- No
Publications
Kalra 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 34057734Garg A, Butz AM, Dworkin PH, Lewis RA, Thompson RE, Serwint JR. Improving the management of family psychosocial problems at low-income children's well-child care visits: the WE CARE Project. Pediatrics. 2007 Sep;120(3):547-58. doi: 10.1542/peds.2007-0398.
PubMed 17766528
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing a Medical Home for Vulnerable Children by Addressing Family Psychosocial Problems at Well-Child Care Visits: THE WE CARE Project
- ClinicalTrials.gov ID
- NCT00397644
- Acronym / sponsor ID
- 20060351
- Keywords
- pediatrician, well-child care visit, low-income children, family psychosocial problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- The Commonwealth Fund
- Study start
- Mar 2006
- Study completion
- Jun 2006
- First posted
- 9 Nov 2006 (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.
The objective of this study is to evaluate the impact and feasibility of a practice-based intervention on the discussion and referral of family psychosocial topics at well-child care visits at a medical home for low-income children.
Detailed description
Many low-income families have family psychosocial problems such as unemployment, housing difficulties, and food insecurity. Pediatric guidelines that pediatricians should be discussing and assisting these families. However, to date few routine do. The primary hypotheses for this study is that the WE CARE (Well-child care visit, Evaluation, Community resources, Advocacy, Referral, Education)intervention would increase the discussion and referral rates for family psychosocial problems at well-child care visits.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Caregivers of children aged 2 months to 10 years who present for well-child care visit at a pediatric clinic
Key exclusion criteria (4 listed)
- Non-English speaking
- Foster parents
- Previously enrolled parent
- No access to telephone
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 |
|---|---|---|
| Prompting (survey instrument/resources list) (behavior) | Behavioural | – |
Primary outcome
Discussion of family psychosocial problem
Referral of family psychosocial problem
Contacting community resources
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 1 Nov 2023.
- 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 17766528Garg A, Butz AM, Dworkin PH, Lewis RA, Thompson RE, Serwint JR. Improving the management of family psychosocial problems at low-income children's well-child care visits: the WE CARE Project. Pediatrics. 2007 Sep;120(3):547-58. doi: 10.1542/peds.2007-0398.
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.
Arvin Garg, MD, MPH principal investigator
Johns Hopkins School of Medicine
Janet Serwint, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prompting (survey instrument/resources list) (behavior) in people with Low-income Children's Well-child Care Visit, run by Johns Hopkins University 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 1 inclusion and 4 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 1 Nov 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?
Discussion of family psychosocial problem. The study lists 3 primary outcomes in all. 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 NCT00397644, which also lists 2 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 1 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.