Adults 12 to 26, any sex, with Depression or Suicidal Ideation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Personalized ReferralPrimary· Baseline (in office) visit
The rate of personalized referrals by primary care providers and treatment initiation among adolescents who screen positive for depression or suicidal ideation will be monitored to determine if provider made referral as recommended on intervention report.
This initial outcome has been modified as a result of the changes in study design.
All recommendations combined
Group
Value
95% CI
Screening Wizard
22
Treatment As Usual (TAU)
15
Screening Wizard
11
Treatment As Usual (TAU)
18
Watchful Waiting recommendation
Group
Value
95% CI
Screening Wizard
8
Treatment As Usual (TAU)
10
Screening Wizard
2
Treatment As Usual (TAU)
0
Ask parent further questions recommendation
Group
Value
95% CI
Screening Wizard
1
Treatment As Usual (TAU)
0
Screening Wizard
0
Treatment As Usual (TAU)
0
Conduct a safety plan assessment recommendation
Group
Value
95% CI
Screening Wizard
0
Treatment As Usual (TAU)
0
Screening Wizard
5
Treatment As Usual (TAU)
12
Refer to embedded therapist recommendation
Group
Value
95% CI
Screening Wizard
1
Treatment As Usual (TAU)
2
Screening Wizard
2
Treatment As Usual (TAU)
4
Recommend referral to specialty depression clinic to evaluate suicidality
Group
Value
95% CI
Screening Wizard
1
Treatment As Usual (TAU)
0
Screening Wizard
0
Treatment As Usual (TAU)
0
Substance use referral recommendation
Group
Value
95% CI
Screening Wizard
0
Treatment As Usual (TAU)
0
Screening Wizard
1
Treatment As Usual (TAU)
0
No treatment needed, rescreen if concern for non-disclosure recommendation
Group
Value
95% CI
Screening Wizard
10
Treatment As Usual (TAU)
3
Screening Wizard
0
Treatment As Usual (TAU)
0
Number of Participants Who Utilized the Screening Wizard ApplicationSecondary· Baseline (phone) visit
Use of the technical components of Screening Wizard will be monitored. Utilization will be measured by the number and proportion of adolescents, parents, and providers who have engaged with the application over time.
Group
Value
95% CI
Screening Wizard
27
Treatment As Usual (TAU)
26
Service Use (Number of Participants at Baseline)Secondary· At Baseline phone visit
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm.
Use outpatient services
Group
Value
95% CI
Screening Wizard
19
Treatment As Usual (TAU)
6
Use school services
Group
Value
95% CI
Screening Wizard
14
Treatment As Usual (TAU)
6
Use ER services
Group
Value
95% CI
Screening Wizard
2
Treatment As Usual (TAU)
2
Use legal services
Group
Value
95% CI
Screening Wizard
1
Treatment As Usual (TAU)
0
Use inpatient services
Group
Value
95% CI
Screening Wizard
3
Treatment As Usual (TAU)
1
Use medications
Group
Value
95% CI
Screening Wizard
15
Treatment As Usual (TAU)
6
Service Use (Number of Participants at 4 Week Follow-up)Secondary· Week 4 follow-up after Baseline
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm.
Use outpatient services
Group
Value
95% CI
Screening Wizard
14
Treatment As Usual (TAU)
6
Use school services
Group
Value
95% CI
Screening Wizard
5
Treatment As Usual (TAU)
4
Use ER services
Group
Value
95% CI
Screening Wizard
0
Treatment As Usual (TAU)
0
Use legal services
Group
Value
95% CI
Screening Wizard
0
Treatment As Usual (TAU)
0
Use inpatient services
Group
Value
95% CI
Screening Wizard
0
Treatment As Usual (TAU)
0
Use medications
Group
Value
95% CI
Screening Wizard
11
Treatment As Usual (TAU)
3
Service Use (Number of Participants at 12 Week Follow-up)Secondary· Week 12 follow up after Baseline
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm.
Use outpatient services
Group
Value
95% CI
Screening Wizard
13
Treatment As Usual (TAU)
7
Use school services
Group
Value
95% CI
Screening Wizard
5
Treatment As Usual (TAU)
3
Use ER services
Group
Value
95% CI
Screening Wizard
0
Treatment As Usual (TAU)
0
Use legal services
Group
Value
95% CI
Screening Wizard
0
Treatment As Usual (TAU)
1
Use inpatient services
Group
Value
95% CI
Screening Wizard
0
Treatment As Usual (TAU)
0
Use medications
Group
Value
95% CI
Screening Wizard
11
Treatment As Usual (TAU)
4
Usability & SatisfactionSecondary· At exit interview after Baseline phone visit. The baseline visit occurs 24-48 hours after initial screening and the exit interview call will be made within 1 month following the completion of the baseline phone assessment.
Satisfaction to Screening Wizard will be assessed through a question developed by investigators to understand experience with the program. The question investigators have adapted from literature reviews on satisfaction is: "If a friend were in need of a mental health referral, would you recommend Screening Wizard to him/her? The response options include: No, definitely not; No, I don't think so; Yes, I think so; Yes, definitely.
Group
Value
95% CI
Screening Wizard
0
Screening Wizard
6
Screening Wizard
12
Screening Wizard
4
Usability & SatisfactionSecondary· At exit interview after Baseline phone visit. The baseline visit occurs 24-48 hours after initial screening and the exit interview call will be made within 1 month following the completion of the baseline phone assessment.
Satisfaction with the technical components of interventions will be assessed through certain questions from the Post System Satisfaction and Usability Questionnaire (PSSUQ). The PSSUQ is 19 items with response options ranging from 1 to 7 where 1=strongly disagree and 7=strongly agree. The PSSUQ has sub-scores derived from subsets of the questions which reflect system usefulness, information quality, and interface quality. Questions from sub-domains were chosen to tailor the questioning to this particular intervention. Another question about the need to learn new things before using the app was
Overall, I am satisfied with how easy it is to use Screening Wizard
Group
Value
95% CI
Screening Wizard
6.2
± 1.3
The information such as online help, on-screen messages, and other documentation, provided was clear
Group
Value
95% CI
Screening Wizard
6.2
± 1
I liked interacting with the Screening Wizard app
Group
Value
95% CI
Screening Wizard
5.7
± 1.2
I needed to learn a lot of things before I could get going with the Screening Wizard
Group
Value
95% CI
Screening Wizard
1.5
± 0.7
Cost Analysis: Cost of Screening Wizard Intervention at BaselineSecondary· At Baseline
An overall average of the cost of implementing the Screening Wizard intervention (including labor, equipment, supplies, facilitates) will be estimated at Baseline.
Group
Value
95% CI
Screening Wizard
160.34
81.54 – 198.88
Sponsor's own description
Screening Wizard (SW). Primary Care Providers (PCPs) are often uncertain about how to best refer adolescents who screen positive for depression or suicidality. Screen-positive youth who are either not in treatment, or express dissatisfaction with current treatment will be consented by an on-site research assistant (RA). Those parents and patients receiving SW will answer additional questions: adaptive screens developed in a previous NIMH study (MH100155) for suicidal risk, anxiety, and mania; perceived barriers; and preferences about treatment. SW generates recommendations for PCPs reflecting patient clinical needs and preferences.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Pittsburgh
Last refreshed: 15 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03985813.