Screening Wizard- Phase 2

NCT04646369 | Completed Results

• 2 other identifiers: STUDY20060325P50MH115838-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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). 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).

Conditions

Depression; Suicidal Ideation

Keywords

depression; anxiety; suicidal ideation; treatment; referral; screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Cost Analysis: Cost of Screening Wizard Intervention at Baseline

  At Baseline visit

• 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 Technical Components

  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

Study Arms (3)

"screening as usual"

ACTIVE COMPARATOR

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"

Screening Wizard 2.0

EXPERIMENTAL

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 2.0 + SOVA

EXPERIMENTAL

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

Interventions

"screening as usual" BEHAVIORAL

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

"screening as usual"

Screening Wizard 2.0 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.

Screening Wizard 2.0

Screening Wizard 2.0 + SOVA 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. SOVA is a peer-support website that social workers and doctors moderate on a 24 hour a day basis.

Screening Wizard 2.0 + SOVA

Eligibility Criteria

• Age: 12 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

UPMC Center for Adolescent and Young Adult Health

Pittsburgh, Pennsylvania, 15213, United States

Location

Kids Plus Pediatrics

Pittsburgh, Pennsylvania, 15217, United States

Location

MeSH Terms

Conditions

Depression; Suicidal Ideation; Anxiety Disorders

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Limitations and Caveats

The small sample limited the ability to detect statistical significance and practice sites had significant involvement from the research team. Both of these factors limit the generalizability of the results.

Results Point of Contact

• Title: Oliver Lindhiem
• Organization: University of Pittsburgh

lindhiemoj@upmc.edu

4122465909

Study Officials

• Oliver Lindhiem, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Ana Radovic

  University of Pittsburgh

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be masked to the intervention condition at follow-up assessment time points.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Model Details: This study will use a parallel study design, where participants are randomized into three intervention groups ("screening as usual", Screening Wizard 2.0, Screening Wizard 2.0 + SOVA) and will receive interventions in parallel.

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 27, 2020
• Study Start: November 5, 2020
• Primary Completion: September 17, 2021
• Study Completion: September 17, 2021
• Last Updated: October 7, 2022
• Results First Posted: September 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: These data will be released to the NDCT soon after each project's "main outcomes" manuscript is accepted for publication
• Access Criteria: In addition to public access to the NDCT, data can also be accessed by contacting ETUDES Center investigators.

Locations

US (2)