Universal Screening for Maternal Depression With the CHICA System

This study has been completed.

Sponsor:

Collaborator:

National Library of Medicine (NLM)

Information provided by:

Indiana University

ClinicalTrials.gov Identifier:

NCT01238614

First received: November 9, 2010

Last updated: NA

Last verified: November 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	November 9, 2010
Last Updated Date	November 9, 2010
Start Date ^ICMJE	October 2007
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 9, 2010)	Percent of mothers screening positive for maternal depression. [ Time Frame: 1 year after child's birth ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: November 9, 2010)	Percent of mothers diagnosed with maternal depression [ Time Frame: one year after child's birth ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Universal Screening for Maternal Depression With the CHICA System
Official Title ^ICMJE	Universal Screening for Maternal Depression With the CHICA System
Brief Summary	The CHICA system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians. We will be studying whether it can help in the diagnosis and referral of mothers with maternal depression.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Screening
Condition ^ICMJE	Maternal Depression
Intervention ^ICMJE	Other: CHICA PSF plus JIT Other: CHICA maternal depression PSF Other: Control
Study Arm (s)	Experimental: PSF-JIT Mothers in this arm receive prescreening questions and clinicians receive just-in-time handouts to aid in diagnosis. Intervention: Other: CHICA PSF plus JIT Experimental: PSF Mothers in this arm receive screening questions on the prescreener form Intervention: Other: CHICA maternal depression PSF Placebo Comparator: Control Mothers in this arm receive no maternal depression CHICA additional care Intervention: Other: Control
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	3250
Completion Date	September 2010
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: All families of patients age 0 to 15 months Exclusion Criteria: None
Gender	Female
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01238614
Other Study ID Numbers ^ICMJE	MLM-CHICA-K-MD, K22LM009160
Has Data Monitoring Committee	No
Responsible Party	Paul Biondich, IUPUI
Study Sponsor ^ICMJE	Indiana University
Collaborators ^ICMJE	National Library of Medicine (NLM)
Investigators ^ICMJE	Not Provided
Information Provided By	Indiana University
Verification Date	November 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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