Screening Wizard- Phase 2

The Center for Enhancing Treatment & Utilization for Depression and Emergent Suicidality Phase 2-Study 1-Screening Wizard

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). Participants will answer questions via adaptive screens developed in a previous NIMH study (MH100155) for suicidal risk, anxiety, and mania. These will address perceived barriers and preferences about treatment. Participants are then randomized into 1 of 3 groups: 1) Providing the symptoms scores report of results to their provider based on their Screening Wizard responses (Screening as Usual); 2) Providing the symptoms scores report and their responses to treatment preferences and barriers including treatment recommendations their provider might suggest (Screening Wizard 2.0); or 3) Providing the report with treatment recommendations to their provider and a website called SOVA or Supporting Our Valued Adolescent, that is aimed at addressing perceptions about mental health providing support to teens through peer interaction that social workers and doctors moderate on a 24 hour a day basis (Screening Wizard 2.0 + SOVA).

Study Overview

• Status: Completed
• Conditions: Depression; Suicidal Ideation
• Intervention / Treatment: Behavioral: "screening as usual"; Behavioral: Screening Wizard 2.0; Behavioral: Screening Wizard 2.0 + SOVA

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 the same visit.

Assignment of Interventions: This study will randomize participants to one of three conditions in a 2:2:1 randomization scheme to either receive "screening as usual" (n=20), Screening Wizard 2.0 (n=40), or Screening Wizard 2.0 + SOVA (n =40)

Hypothesis: H1: Screening Wizard 2.0 will result in more referrals compared to "screening as usual" (increase >30% compared to "screening as usual")

H2: Screening Wizard 2.0 will result in higher rates of follow-through with mental health services compared to "screening as usual" (increase >30% compared to "screening as usual")

H3: Screening Wizard 2.0 will have higher adolescent and parent perception of being involved in a shared decision-making process compared to "Treatment as usual" (SW involvement > "screening as usual" involvement )

H4: Adolescent and parents in Screening Wizard 2.0 + SOVA will have less negative attitudes about psychotherapy, higher depression literacy, and a higher readiness for treatment as compared to Screening Wizard 2.0 alone or "screening as usual"

H5: Adolescent and parents in Screening Wizard 2.0 + SOVA will result in higher rates of follow-through with mental health services (defined as attendance at an initial appointment) compared to Screening wizard 2.0 alone (increase >10%) and "screening as usual" (increase >40%)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Center for Adolescent and Young Adult Health
    • Pittsburgh, Pennsylvania, United States, 15217
      • Kids Plus Pediatrics

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:

1. Youth aged 12-26yo
2. Biological or adoptive parent is willing to provide informed consent for teen to participate
3. Youth speaks and understands English

Exclusion Criteria:

1. Non English speaking
2. No parent willing to provide informed consent
3. 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: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: "screening as usual"; Participants in the "screening as usual' group will have a symptoms scores report of results sent to their provider based on their Screening Wizard responses.	Behavioral: "screening as usual"; Participants in this group will receive usual care at their pediatric primary care practice following information, psychoeducation, and referral to a mental health treatment provider
Experimental: Screening Wizard 2.0; Participants in the Screening Wizard 2.0 Report group will have a symptoms scores report of results and treatment preferences, barriers, and recommendations sent to their provider based on their Screening Wizard responses.	Behavioral: Screening Wizard 2.0; 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.
Experimental: Screening Wizard 2.0 + SOVA; Participants in the Screening Wizard 2.0 + SOVA group will have a symptoms scores report of results and treatment preferences, barriers, and recommendations sent to their provider based on their Screening Wizard responses. This group will also receive access to the SOVA website aimed at addressing perceptions about mental health providing support to teens through peer interaction.	Behavioral: Screening Wizard 2.0 + SOVA; 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. SOVA is a peer-support website that social workers and doctors moderate on a 24 hour a day basis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Referred to Treatment	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 referrals.	Baseline (in office) visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 visit
Usability & Satisfaction	Satisfaction to Screening Wizard will be assessed through questions developed by investigators to understand experience with the program. Questions investigators have adapted from literature reviews on satisfaction include: If a friend were in need of a mental health referral, would you recommend Screening Wizard to him/her? (SCALE: No, definitely not-Yes, definitely/1-4) How satisfied are you with the amount of help you received? (SCALE: Very dissatisfied-Very satisfied/1-4) Have the services you received helped you to deal more effectively with your problems? (SCALE: Seemed to make things worse-Yes, a great deal/1-4)	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 Technical Components	Satisfaction with the technical components of interventions will be assessed through the 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. 4 Questions from sub-domains were chosen to tailor the questioning to this particular intervention.	At exit interview after Baseline phone visit. The Baseline visit occurs 24-48 hours after initial screening and the exit interview call will be make within 1 month following the completion of the Baseline phone assessment

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, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Actual): September 17, 2021
• Study Completion (Actual): September 17, 2021

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: treatment; depression; anxiety; screening; suicidal ideation; referral
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Self-Injurious Behavior; Suicide; Depression; Depressive Disorder; Suicidal Ideation
• Other Study ID Numbers: STUDY20060325; 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