An interventional study of Computerized Assessment and Referral System (CARS) Self-Assessment Screener and CARS-SA Summary Results in Mental Health, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-24.
Sponsored by University of Arkansas · Not applicable, Interventional, and Health services research
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Among 654 studies in Psychological Well-Being with a site in United States — 188 open to participants now, 239 under way, 1 of them phase 3. Psychological Well-Being · United States.
Among the 654 studies in Psychological Well-Being with a site in United States, this one is the 101st largest by enrollment of the 572 interventional ones that give a count, is one of 17 that started in 2017, is one of 514 with no phase, and was the 157th registered.
2,195 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
Browse Psychological Well-Being studies →188 of the 654 studies in Psychological Well-Being with a site in United States are open now. Recruiting first, the newest first:
Columbia University · Sites in United States
Ages 12–80
Chestnut Health Systems · Sites in United States
Ages 18+ · Healthy volunteers
University of Massachusetts, Worcester · Sites in United States
Ages 18+
Beth Israel Deaconess Medical Center · Sites in United States
Ages 18–40 · Healthy volunteers
University of South Carolina · Sites in United States
Ages 18+ · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 401 Psychological Well-Being studies recruiting now, 218 (54%) set no upper age limit and 157 (39%) stop at 75 or younger; 120 take children under 18; 204 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
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654 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 20 · Phase 2 29 · Phase 3 10 · Phase 4 6
First in 1996; this study’s year is marked. 17 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 451 is above the median of 110 across 1,798 interventional studies indexed under Psychological Well-Being.
Median enrollment 116 across the 572 interventional studies, 500 across the 81 observational. Of the 383 that completed or were terminated, 120 (31%) have results posted.
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53 of 654 have an industry lead sponsor. The 10 most frequent:
University of Arkansas is the lead sponsor of 399 studies on the registry; 38 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 35 (95%) have results posted.
University of Arkansas has 3 studies filed under Psychological Well-Being — fewer than ten, so there is no comparison to draw.
99 of the studies in Psychological Well-Being with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07011459Tulane UniversityThe Cooking for Health Optimization and Disease Prevention (CHOP) Trial | 2026-11 |
| NCT07718646Oklahoma State UniversityMobile Health Coping Intervention for Mothers Experiencing Food Insecurity | 2026-11 |
| NCT06915259University of PennsylvaniaDoula Model of Care | 2026-11 |
| NCT04833829Emory UniversityCross-disciplinary HIV Integrated Mental Health Support Intervention | 2026-11 |
| NCT06989593Sarah SchlegelBreaking Silence Through Story: A Narrative Medicine Intervention for Parents of Children With Urogenital Conditions | 2026-11 |
Add all 99 to your calendar (.ics) → With an account.
Among the 654 studies in Psychological Well-Being with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a hybrid effectiveness-implementation randomized controlled trial which will be conducted at the emergency department (ED) at the University of Arkansas for Medical Sciences (UAMS) in Little Rock, Arkansas.
The hypothesis of this study is that use of the CARS (a computerized mental health screener) will modify emergency department treatment of patients with previously undiagnosed mental illness.
This pragmatic mixed methods clinical trial will compare the intervention of providing a CARS screener report to emergency providers to not providing the report. It will also collect qualitative data regarding implementation of the CARS screener and report. Consecutive patients presenting when a research associate is available will be approached to participate. Patients will be approached after evaluation by an emergency physician.
The Computerized Assessment and Referral System (CARS) is based on the Composite International Diagnostic Interview (CIDI), a validated instrument for assessing mental health diagnoses.CARS was piloted at 6 different sites in 2016, all in DUI populations. As CARS has not been specifically validated on non-DUI populations, investigators will collect alcohol history (see below). The CARS self-assessment version (CARS-SA) will be utilized in this study.
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Exclusion Criteria:
Emergency care providers for subjects in this group will receive a copy of the subject's CARS-SA summary results.
Behavioral: Computerized Assessment and Referral System (CARS) Self-Assessment Screener · Behavioral: CARS-SA Summary Results
Emergency care providers for subjects in this group will not receive a copy of the subject's CARS-SA summary results.
Behavioral: Computerized Assessment and Referral System (CARS) Self-Assessment Screener
Subjects will take the CARS-SA Screener.
Also known as: CARS-SA Screener
Subjects will be evaluated by emergency care providers using the CARS-SA Summary Results Report.
Also known as: CARS-SA Report
Number of Participants With CARS Mental Health Diagnoses Made in the ED; the Number of Psychiatry Evaluations in the Emergency Department (ED); and the Number of Mental Health Referrals Made From the ED
The composite measure includes: the number of CARS mental health diagnoses made in the ED; the number of psychiatry evaluations in the emergency department (ED); and the number of mental health referrals made from the ED.
Time frame: Up to 12 hours
| Milestone | CARS Report | No CARS Report |
|---|---|---|
| Started | 213 | 238 |
| Completed | 213 | 238 |
| Not completed | 0 | 0 |
The composite measure includes: the number of CARS mental health diagnoses made in the ED; the number of psychiatry evaluations in the emergency department (ED); and the number of mental health referrals made from the ED.
| Participants | CARS Report | No CARS Report |
|---|---|---|
| Number of Participants With CARS Mental Health Diagnoses Made in the ED; the Number of Psychiatry Evaluations in the Emergency Department (ED); and the Number of Mental Health Referrals Made From the ED | 1 | 1 |
Collected over Duration of ED visit (typically 2 hours). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CARS Report | 0/213 (0%) | 0/213 (0%) | 0/213 (0%) |
| No CARS Report | 0/238 (0%) | 0/238 (0%) | 0/238 (0%) |
| Age, Continuous(years) | CARS Report | No CARS Report | Total |
|---|---|---|---|
| Mean | 40.28 ± 16.23 | 40.79 ± 15.45 | 40.55 ± 15.81 |
| Sex: Female, Male(Participants) | CARS Report | No CARS Report | Total |
|---|---|---|---|
| Female | 121 | 145 | 266 |
| Male | 92 | 93 | 185 |
| Race and Ethnicity Not Collected(Participants) | CARS Report | No CARS Report | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Dec 2019, 23 months.
Results were first posted in Jun 2021, 1 year 6 months after primary completion.
Of 1,261 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's 23 months is above that.
Counting every sponsor, half of 1,304 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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