Screening Wizard, Component 1 of iCHART (Integrated Care to Help At-Risk Teens)-Feasibility/Pilot Phase
Primary Purpose
Depression, Suicidal Ideation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screening Wizard
Sponsored by
About this trial
This is an interventional health services research trial for Depression
Eligibility Criteria
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.
Sites / Locations
- Children's Community Pediatrics (CCP-Bass Wolfson Cranberry) of Children's Hospital of Pittsburgh of UPMC
- Children's Hospital of Pittsburgh Department of Neurology
- Children's Primary Care Center (PCC) of Children's Hospital of Pittsburgh of UPMC
- UPMC Center for Adolescent and Young Adult Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Screening Wizard
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03985813
First Posted
June 5, 2019
Last Updated
July 13, 2022
Sponsor
University of Pittsburgh
Collaborators
Kaiser Foundation Research Institute, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03985813
Brief Title
Screening Wizard, Component 1 of iCHART (Integrated Care to Help At-Risk Teens)-Feasibility/Pilot Phase
Official Title
Screening Wizard, Component 1 of iCHART (Integrated Care to Help At-Risk Teens)-Feasibility/Pilot Phase
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 13, 2019 (Actual)
Primary Completion Date
October 15, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Kaiser Foundation Research Institute, National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Suicidal Ideation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Masking Description
Outcome assessors will be masked to the intervention condition at follow-up assessment timepoints.
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Screening Wizard
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Screening Wizard
Intervention Description
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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
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.
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.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Lindhiem, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana Radovic, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Director
Facility Information:
Facility Name
Children's Community Pediatrics (CCP-Bass Wolfson Cranberry) of Children's Hospital of Pittsburgh of UPMC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Children's Hospital of Pittsburgh Department of Neurology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Children's Primary Care Center (PCC) of Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Center for Adolescent and Young Adult Health
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
These data will be released to the NDCT soon after each project's "main outcomes" manuscript is accepted for publication.
IPD Sharing Access Criteria
In addition to public access to the NDCT, data can also be accessed by contacting ETUDES Center investigators.
Learn more about this trial
Screening Wizard, Component 1 of iCHART (Integrated Care to Help At-Risk Teens)-Feasibility/Pilot Phase
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