Screening Wizard, Component 1 of iCHART (Integrated Care to Help At-Risk Teens)-Feasibility/Pilot Phase

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT03985813
• Collaborator: Kaiser Foundation Research Institute (Other), National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 53
• Locations: 4
• Arm: 1
• Actual Duration (Months): 14.1
• Patients Per Site: 13.3
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Depression; Suicidal Ideation	Behavioral: Screening Wizard	N/A

Detailed Description

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Masking Description: Outcome assessors will be masked to the intervention condition at follow-up assessment timepoints.
• Primary Purpose: Health Services Research
• Official Title: Screening Wizard, Component 1 of iCHART (Integrated Care to Help At-Risk Teens)-Feasibility/Pilot Phase
• Actual Study Start Date: Aug 13, 2019
• Actual Primary Completion Date: Oct 15, 2020
• Actual Study Completion Date: Oct 15, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. Personalized Referral [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.

Secondary Outcome Measures

1. Number of Participants Who Utilized the Screening Wizard Application [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.

2. Service Use (Number of Participants at Baseline) [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.

3. Service Use (Number of Participants at 4 Week Follow-up) [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.

4. Service Use (Number of Participants at 12 Week Follow-up) [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.

5. Usability & Satisfaction [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.

6. Usability & Satisfaction [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 asked to be rated on a 1-5 scale, with 1= strongly disagree and 5= strongly agree.

7. Cost Analysis: Cost of Screening Wizard Intervention at Baseline [At Baseline]

   An overall average of the cost of implementing the Screening Wizard intervention (including labor, equipment, supplies, facilitates) will be estimated at Baseline.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 26 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Youth aged 12-26 yo

• Biological or adoptive parent is willing to provide informed consent for teen to participate

• Youth speaks and understands English

Exclusion Criteria:

• Non English speaking

• No parent willing to provide informed consent

• Is currently experiencing acute mania or psychosis, evidence of an intellectual or developmental disorder (IDD), life threatening medical condition that requires immediate treatment, or other cognitive or medical condition preventing youth from understanding study and/or participating.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Community Pediatrics (CCP-Bass Wolfson Cranberry) of Children's Hospital of Pittsburgh of UPMC	Cranberry Township	Pennsylvania	United States	16066
2	Children's Hospital of Pittsburgh Department of Neurology	Pittsburgh	Pennsylvania	United States	15213
3	Children's Primary Care Center (PCC) of Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania	United States	15213
4	UPMC Center for Adolescent and Young Adult Health	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh
• Kaiser Foundation Research Institute
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Oliver Lindhiem, PhD, University of Pittsburgh
• Study Director: Ana Radovic, MD, University of Pittsburgh

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 12, 2021
• Informed Consent Form - Apr 12, 2021

More Information

Publications

None provided.

• Responsible Party: Oliver Lindhiem, Associate Professor of Psychiatry, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03985813
• Other Study ID Numbers: STUDY18110137; P50MH115838-02
• First Posted: Jun 14, 2019
• Last Update Posted: Jul 15, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Suicidal Ideation

Study Results

Participant Flow

Pre-assignment Detail	Some participants were enrolled into the TAU arm prior to converting from a stepped wedge design to an open design.

Arm/Group Title	Screening Wizard	Treatment As Usual (TAU)
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	27	26
COMPLETED	27	26
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Screening Wizard	Treatment As Usual (TAU)	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	27	26	53
Age (Count of Participants)
<=18 years	10 37%	26 100%	36 67.9%
Between 18 and 65 years	17 63%	0 0%	17 32.1%
>=65 years	0 0%	0 0%	0 0%
Sex/Gender, Customized (Count of Participants)
Male	7 25.9%	14 53.8%	21 39.6%
Female	17 63%	12 46.2%	29 54.7%
Male to Female Transgender	1 3.7%	0 0%	1 1.9%
Female to Male Transgender	2 7.4%	0 0%	2 3.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 3.7%	2 7.7%	3 5.7%
Not Hispanic or Latino	26 96.3%	24 92.3%	50 94.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	3 11.1%	0 0%	3 5.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 11.1%	11 42.3%	14 26.4%
White	19 70.4%	13 50%	32 60.4%
More than one race	1 3.7%	1 3.8%	2 3.8%
Unknown or Not Reported	1 3.7%	1 3.8%	2 3.8%
Region of Enrollment (participants) [Number]
United States	27 100%	26 100%	53 100%

Outcome Measures

1. Primary Outcome

Title	Personalized Referral
Description	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.
Time Frame	Baseline (in office) visit

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Screening Wizard	Treatment As Usual (TAU)
Arm/Group Description	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.	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.
Measure Participants	27	26
Measure Recommendations	33	33
Agree with recommendation	22	15
Disagree with recommendation	11	18
Agree with recommendation	8	10
Disagree with recommendation	2	0
Agree with recommendation	1	0
Disagree with recommendation	0	0
Agree with recommendation	0	0
Disagree with recommendation	5	12
Agree with recommendation	1	2
Disagree with recommendation	2	4
Agree with recommendation	1	0
Disagree with recommendation	0	0
Agree with recommendation	0	0
Disagree with recommendation	1	0
Agree with recommendation	10	3
Disagree with recommendation	0	0
Agree with recommendation	0	0
Disagree with recommendation	1	1
Agree with recommendation	1	0
Disagree with recommendation	0	0
Agree with recommendation	0	0
Disagree with recommendation	0	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Screening Wizard, Treatment As Usual (TAU)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.083
	Comments	Threshold for significance P<0.05
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Number of Participants Who Utilized the Screening Wizard Application
Description	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.
Time Frame	Baseline (phone) visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Screening Wizard	Treatment As Usual (TAU)
Arm/Group Description	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.	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.
Measure Participants	27	26
Count of Participants [Participants]	27 100%	26 100%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Screening Wizard, Treatment As Usual (TAU)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.99
	Comments	Threshold for statistical significance P<0.05
	Method	Chi-squared
	Comments

3. Secondary Outcome

Title	Service Use (Number of Participants at Baseline)
Description	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.
Time Frame	At Baseline phone visit

Outcome Measure Data

Analysis Population Description

All participants in both arms responded to CASA questions for Baseline assessment.

Arm/Group Title	Screening Wizard	Treatment As Usual (TAU)
Arm/Group Description	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.	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.
Measure Participants	27	26
Use outpatient services	19 70.4%	6 23.1%
Use school services	14 51.9%	6 23.1%
Use ER services	2 7.4%	2 7.7%
Use legal services	1 3.7%	0 0%
Use inpatient services	3 11.1%	1 3.8%
Use medications	15 55.6%	6 23.1%

4. Secondary Outcome

Title	Service Use (Number of Participants at 4 Week Follow-up)
Description	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.
Time Frame	Week 4 follow-up after Baseline

Outcome Measure Data

Analysis Population Description

All Screening WIzard intervention participants responded to 4 week CASA assessment and 25/26 Treatment As Usual participants responded to 4 week CASA assessment.

Arm/Group Title	Screening Wizard	Treatment As Usual (TAU)
Arm/Group Description	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.	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.
Measure Participants	27	25
Use outpatient services	14 51.9%	6 23.1%
Use school services	5 18.5%	4 15.4%
Use ER services	0 0%	0 0%
Use legal services	0 0%	0 0%
Use inpatient services	0 0%	0 0%
Use medications	11 40.7%	3 11.5%

5. Secondary Outcome

Title	Service Use (Number of Participants at 12 Week Follow-up)
Description	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.
Time Frame	Week 12 follow up after Baseline

Outcome Measure Data

Analysis Population Description

26/27 Screening Wizard intervention participants completed CASA assessment and all Treatment As Usual participants completed CASA assessment.

Arm/Group Title	Screening Wizard	Treatment As Usual (TAU)
Arm/Group Description	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.	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.
Measure Participants	26	26
Use outpatient services	13 48.1%	7 26.9%
Use school services	5 18.5%	3 11.5%
Use ER services	0 0%	0 0%
Use legal services	0 0%	1 3.8%
Use inpatient services	0 0%	0 0%
Use medications	11 40.7%	4 15.4%

6. Secondary Outcome

Title	Usability & Satisfaction
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Screening Wizard
Arm/Group Description	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.
Measure Participants	22
No, definitely not	0 0%
No, I don't think so	6 22.2%
Yes, I think so	12 44.4%
Yes, definitely	4 14.8%

7. Secondary Outcome

Title	Usability & Satisfaction
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Screening Wizard
Arm/Group Description	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.
Measure Participants	19
Overall, I am satisfied with how easy it is to use Screening Wizard	6.2 (1.3)
The information such as online help, on-screen messages, and other documentation, provided was clear	6.2 (1)
I liked interacting with the Screening Wizard app	5.7 (1.2)
I needed to learn a lot of things before I could get going with the Screening Wizard	1.5 (0.7)

8. Secondary Outcome

Title	Cost Analysis: Cost of Screening Wizard Intervention at Baseline
Description	An overall average of the cost of implementing the Screening Wizard intervention (including labor, equipment, supplies, facilitates) will be estimated at Baseline.
Time Frame	At Baseline

Outcome Measure Data

Analysis Population Description

All 27 participants enrolled engaged in using Screening Wizard intervention.

Arm/Group Title	Screening Wizard
Arm/Group Description	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.
Measure Participants	27
Mean (Full Range) [dollars per participant]	160.34

Adverse Events

Time Frame	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)
Arm/Group Title	Screening Wizard		Treatment As Usual (TAU)
Arm/Group Description	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.		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.
All Cause Mortality
	Screening Wizard		Treatment As Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/26 (0%)
Serious Adverse Events
	Screening Wizard		Treatment As Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Screening Wizard		Treatment As Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/26 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.