NCT00397644

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2006

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

First QC Date

November 7, 2006

Last Update Submit

October 31, 2023

Conditions

Keywords

pediatricianwell-child care visitlow-income childrenfamily psychosocial problem

Outcome Measures

Primary Outcomes (3)

  • Discussion of family psychosocial problem

  • Referral of family psychosocial problem

  • Contacting community resources

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Caregivers of children aged 2 months to 10 years who present for well-child care visit at a pediatric clinic

You may not qualify if:

  • Non-English speaking
  • Foster parents
  • Previously enrolled parent
  • No access to telephone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harriet Lane Clinic at Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

  • 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.

  • Garg 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.

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Arvin Garg, MD, MPH

    Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR
  • Janet Serwint, MD

    Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2006

First Posted

November 9, 2006

Study Start

March 1, 2006

Study Completion

June 1, 2006

Last Updated

November 1, 2023

Record last verified: 2023-10

Locations