Maternal DepressionNCT01238614
Universal Screening for Maternal Depression With the CHICA System
A study testing CHICA PSF plus JIT and CHICA maternal depression PSF in people with Maternal Depression, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Maternal Depression
- What is being tested?
- CHICA PSF plus JIT and CHICA maternal depression PSF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,250 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Sep 2010
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All families of patients age 0 to 15 months
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Maternal Depression
- Being tested
- CHICA PSF plus JIT, CHICA maternal depression PSF, Control
- Keywords
- maternal depression, clinical decision support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHICA PSF plus JITOther
CHICA maternal depression PSFOther
ControlOther
| Study group | Role | What they receive |
|---|---|---|
| PSF-JIT | Experimental | Mothers in this arm receive prescreening questions and clinicians receive just-in-time handouts to aid in diagnosis. Receives: Other: CHICA PSF plus JIT |
| PSF | Experimental | Mothers in this arm receive screening questions on the prescreener form Receives: Other: CHICA maternal depression PSF |
| Control | Placebo comparator | Mothers in this arm receive no maternal depression CHICA additional care Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of mothers screening positive for maternal depression.
Measured: 1 year after child's birth
Secondary outcomes (1)
Percent of mothers diagnosed with maternal depression
Measured: one year after child's birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startOct 2007
- Primary completionJul 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal DepressionStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Library of Medicine (NLM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238614
- Sponsor's protocol ID
- MLM-CHICA-K-MD
- Other IDs
- K22LM009160
- Status last verified
- Nov 2010
- First submitted
- 9 Nov 2010
- Last updated
- 10 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Universal Screening for Maternal Depression With the CHICA System
- ClinicalTrials.gov ID
- NCT01238614
- Acronym / sponsor ID
- MLM-CHICA-K-MD
- Conditions
- Maternal Depression
- Keywords
- maternal depression, clinical decision support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,250 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Study start
- Oct 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 10 Nov 2010 (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 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PSF-JIT | Experimental | Other: CHICA PSF plus JITMothers in this arm receive prescreening questions and clinicians receive just-in-time handouts to aid in diagnosis. |
| PSF | Experimental | Other: CHICA maternal depression PSFMothers in this arm receive screening questions on the prescreener form |
| Control | Placebo comparator | Other: ControlMothers in this arm receive no maternal depression CHICA additional care |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All families of patients age 0 to 15 months
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| CHICA PSF plus JIT | Other | PSF-JIT |
| CHICA maternal depression PSF | Other | PSF |
| Control | Other | Control |
Primary outcome
Percent of mothers screening positive for maternal depression.
Time frame: 1 year after child's birth
1 secondary outcome
Percent of mothers diagnosed with maternal depression
Time frame: one year after child's birth
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 10 Nov 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHICA PSF plus JIT and CHICA maternal depression PSF in people with Maternal Depression, run by Indiana 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 1 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 10 Nov 2010. 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. Some participants in this study may receive a placebo. 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?
Percent of mothers screening positive for maternal depression. (time frame: 1 year after child's birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2010.