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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Suicidal Ideation
• Intervention / Treatment: Behavioral: Screening Wizard

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Children's Community Pediatrics (CCP-Bass Wolfson Cranberry) of Children's Hospital of Pittsburgh of UPMC
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Center for Adolescent and Young Adult Health
    • Pittsburgh, Pennsylvania, United States, 15213
      • Children's Hospital of Pittsburgh Department of Neurology
    • Pittsburgh, Pennsylvania, United States, 15213
      • Children's Primary Care Center (PCC) of Children's Hospital of Pittsburgh of UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Mental Health (NIMH); Kaiser Foundation Research Institute
• Investigators: Principal Investigator: Oliver Lindhiem, PhD, University of Pittsburgh; Study Director: Ana Radovic, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2019
• Primary Completion (Actual): October 15, 2020
• Study Completion (Actual): October 15, 2020

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: STUDY18110137; P50MH115838-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No