NCT01238614

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration 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

October 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2010

Completed
Last Updated

November 10, 2010

Status Verified

November 1, 2010

Enrollment Period

1.8 years

First QC Date

November 9, 2010

Last Update Submit

November 9, 2010

Conditions

Maternal Depression

Keywords

maternal depressionclinical decision support

Outcome Measures

Primary Outcomes (1)

  • Percent of mothers screening positive for maternal depression.

    1 year after child's birth

Secondary Outcomes (1)

  • Percent of mothers diagnosed with maternal depression

    one year after child's birth

Study Arms (3)

PSF-JIT

EXPERIMENTAL

Mothers in this arm receive prescreening questions and clinicians receive just-in-time handouts to aid in diagnosis.

Other: CHICA PSF plus JIT

PSF

EXPERIMENTAL

Mothers in this arm receive screening questions on the prescreener form

Other: CHICA maternal depression PSF

Control

PLACEBO COMPARATOR

Mothers in this arm receive no maternal depression CHICA additional care

Other: Control

Interventions

CHICA PSF plus JITOTHER
PSF-JIT
CHICA maternal depression PSFOTHER
PSF
ControlOTHER
Control

Eligibility Criteria

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

You may qualify if:

  • All families of patients age 0 to 15 months

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHSR

Indianapolis, Indiana, 46202, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2010

First Posted

November 10, 2010

Study Start

October 1, 2007

Primary Completion

July 1, 2009

Study Completion

September 1, 2010

Last Updated

November 10, 2010

Record last verified: 2010-11

Locations

US(1)