Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P50MH115838-02 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kaiser Foundation Research Institute | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Screening Wizard will be delivered by Primary Care Providers (PCPs) at well child visits, beginning with screening occurring within the waiting room which will yield decision support guidance delivered and followed by the PCP at that same visit.
This study utilized an open trial design. A stepped wedge design was originally proposed and efforts were made to adhere to this study design, however after a year of low recruitment and resultant recruitment sites pulling out the of the study, the overall study design was changed to an open trial. Additional recruitment sites were onboarded to the study and provided with the intervention arm in order to obtain feasibility data on the intervention components of the study. For reference a stepped wedge design involves the sequential random rollout of an intervention over two time periods. Following a baseline period in which no clusters (=practices) are exposed to the intervention, the crossover is typically in one direction, from control to intervention and continues until both of the clusters have crossed-over to receive the intervention, with observations taken from each cluster and at each time period.
Hypothesis: The use of Screening Wizard will increase the rate of personalized referrals experts in specialty mental health would provide, compared to Treatment as usual (TAU).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening Wizard | Experimental | Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening Wizard | Behavioral | Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Personalized Referral | 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. | Baseline (in office) visit |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Utilized the Screening Wizard Application | 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. | Baseline (phone) visit |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Oliver Lindhiem, PhD | University of Pittsburgh | Principal Investigator |
| Ana Radovic, MD | University of Pittsburgh | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Community Pediatrics (CCP-Bass Wolfson Cranberry) of Children's Hospital of Pittsburgh of UPMC | Cranberry Township | Pennsylvania | 16066 | United States |
All requests for study data will follow NIMH's data sharing and data use policies.
The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies, including those funded by the innovation contests. These analytic datasets may also include derived variables with documentation. Our form datasets will include original case report forms, a detailed codebook of variable names, value labels, and programming formats and all study documentation including the protocol and manual of procedures. For descriptive/raw data, study investigators/study staff will upload to NIMH's National Database for Clinical Trials Related to Mental Health Illness (NDCT) on a semi-annual basis all analyzed data being uploaded prior to primary paper publication.
Not provided
These data will be released to the NDCT soon after each project's "main outcomes" manuscript is accepted for publication.
In addition to public access to the NDCT, data can also be accessed by contacting ETUDES Center investigators.
Not provided
Some participants were enrolled into the TAU arm prior to converting from a stepped wedge design to an open design.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Screening Wizard | Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. Screening Wizard: Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. |
| FG001 | Treatment As Usual (TAU) | Youth and parents randomized to TAU will still be approached to take the Screening Wizard questions, but the resulting report will not be relayed to the treating physician. Imminent suicidality will still be addressed per the practices standard of care. In the TAU condition, the list of depression and suicidality items and based on practice preferences, standard of care substance use items, will be printed and handed to the providers. The handout will not include the decision support tool to guide referrals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Screening Wizard | Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. Screening Wizard: Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Personalized Referral | 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. | The number analyzed for each row differs from overall number analyzed as each row is broken into subcategories of recommendations. Not all participants received a specific recommendation. TAU results are recommendations that would have been made based on Screening Wizard algorithm. | Posted | Count of Units | Recommendations | Baseline (in office) visit | Recommendations | Recommendations |
|
Over the 1 year and 1 month of data collection for the study, participants were assessed for adverse events at each timepoint (baseline, 4 week follow-up, 12 week follow-up)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Screening Wizard | Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. Screening Wizard: Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. |
Not provided
Not provided
The study design changed from a stepped wedge design to an open trial. As a feasibility trial, the study was not adequately powered to detect significant effects. In some cases, minor issues with the SW decision tree algorithm led to providers in the SW arm receiving guidance for a higher level of care than was necessary. It's possible that some documentation reviewed in the EHR was missing during the consensus and matching process between the EHR referral data and the SW report.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oliver Lindhiem | University of Pittsburgh | 4122465909 | lindhiemoj@upmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 12, 2021 | Oct 11, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 12, 2021 | Oct 8, 2021 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
Not provided
Not provided
Ultimately, this study design was an open trial after unsuccessful attempts to maintain initial recruitment sites in the study.
This study initially attempted to use a stepped wedge design, which involves the sequential random rollout of an intervention over 2 time periods. Following a baseline period in which no clusters (= practices) are exposed to the intervention, the crossover is typically in one direction, from control to intervention and continues until both of the clusters have crossed-over to receive the intervention, with observations taken from each cluster and at each time period.
Not provided
Not provided
Outcome assessors will be masked to the intervention condition at follow-up assessment timepoints.
Not provided
| Service Use (Number of Participants at 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. |
| At Baseline phone visit |
| Service Use (Number of Participants at 4 Week Follow-up) | 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. | Week 4 follow-up after Baseline |
| Service Use (Number of Participants at 12 Week Follow-up) | 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. | Week 12 follow up after Baseline |
| Usability & Satisfaction | 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. | 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. |
| Usability & Satisfaction | 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 asked to be rated on a 1-5 scale, with 1= strongly disagree and 5= strongly agree. | 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. |
| Cost Analysis: Cost of Screening Wizard Intervention at Baseline | An overall average of the cost of implementing the Screening Wizard intervention (including labor, equipment, supplies, facilitates) will be estimated at Baseline. | At Baseline |
| Children's Hospital of Pittsburgh Department of Neurology | Pittsburgh | Pennsylvania | 15213 | United States |
| Children's Primary Care Center (PCC) of Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| UPMC Center for Adolescent and Young Adult Health | Pittsburgh | Pennsylvania | 15213 | United States |
| BG001 | Treatment As Usual (TAU) | Youth and parents randomized to TAU will still be approached to take the Screening Wizard questions, but the resulting report will not be relayed to the treating physician. Imminent suicidality will still be addressed per the practices standard of care. In the TAU condition, the list of depression and suicidality items and based on practice preferences, standard of care substance use items, will be printed and handed to the providers. The handout will not include the decision support tool to guide referrals. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Treatment As Usual (TAU) | Youth and parents randomized to TAU will still be approached to take the Screening Wizard questions, but the resulting report will not be relayed to the treating physician. Imminent suicidality will still be addressed per the practices standard of care. In the TAU condition, the list of depression and suicidality items and based on practice preferences, standard of care substance use items, will be printed and handed to the providers. The handout will not include the decision support tool to guide referrals. |
|
|
|
| Secondary | Number of Participants Who Utilized the Screening Wizard Application | 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. | Posted | Count of Participants | Participants | Baseline (phone) visit |
|
|
|
|
| Secondary | Service Use (Number of Participants at 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. | All participants in both arms responded to CASA questions for Baseline assessment. | Posted | Count of Participants | Participants | At Baseline phone visit |
|
|
|
| Secondary | Service Use (Number of Participants at 4 Week Follow-up) | 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. | All Screening WIzard intervention participants responded to 4 week CASA assessment and 25/26 Treatment As Usual participants responded to 4 week CASA assessment. | Posted | Count of Participants | Participants | Week 4 follow-up after Baseline |
|
|
|
| Secondary | Service Use (Number of Participants at 12 Week Follow-up) | 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. | 26/27 Screening Wizard intervention participants completed CASA assessment and all Treatment As Usual participants completed CASA assessment. | Posted | Count of Participants | Participants | Week 12 follow up after Baseline |
|
|
|
| Secondary | Usability & Satisfaction | 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. | Out of the 27 participants in the Screening Wizard arm, only 22 answered the satisfaction question at the exit interview. No statistical analysis completed because there is no comparison group. | Posted | Count of Participants | Participants | 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. |
|
|
|
| Secondary | Usability & Satisfaction | 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 asked to be rated on a 1-5 scale, with 1= strongly disagree and 5= strongly agree. | Out of the 27 participants in the Screening Wizard arm, only 19 answered the questions regarding satisfaction with technical components at the exit interview. No statistical analysis completed because there is no comparison group. | Posted | Mean | Standard Deviation | score on a scale | 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. |
|
|
|
| Secondary | Cost Analysis: Cost of Screening Wizard Intervention at Baseline | An overall average of the cost of implementing the Screening Wizard intervention (including labor, equipment, supplies, facilitates) will be estimated at Baseline. | All 27 participants enrolled engaged in using Screening Wizard intervention. | Posted | Mean | Full Range | dollars per participant | At Baseline |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Treatment As Usual (TAU) | Youth and parents randomized to TAU will still be approached to take the Screening Wizard questions, but the resulting report will not be relayed to the treating physician. Imminent suicidality will still be addressed per the practices standard of care. In the TAU condition, the list of depression and suicidality items and based on practice preferences, standard of care substance use items, will be printed and handed to the providers. The handout will not include the decision support tool to guide referrals. | 0 | 26 | 0 | 26 | 0 | 26 |
Not provided
Not provided
Not provided
|
|
|
|
|
|
|
|
|
|
| Use ER services |
|
| Use legal services |
|
| Use inpatient services |
|
| Use medications |
|
| Use ER services |
|
| Use legal services |
|
| Use inpatient services |
|
| Use medications |
|
| Use ER services |
|
| Use legal services |
|
| Use inpatient services |
|
| Use medications |
|
| Yes, definitely |
|
|
| I needed to learn a lot of things before I could get going with the Screening Wizard |
|