Screening Wizard- Phase 2

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT04646369

Collaborator

Kaiser Foundation Research Institute (Other), National Institute of Mental Health (NIMH) (NIH)

100

Enrollment

Locations

Arms

10.4

Actual Duration (Months)

Patients Per Site

4.8

Patients Per Site Per Month

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). 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).

Condition or Disease	Intervention/Treatment	Phase
Depression Suicidal Ideation	Behavioral: "screening as usual" Behavioral: Screening Wizard 2.0 Behavioral: Screening Wizard 2.0 + SOVA	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 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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Outcomes Assessor)

Masking Description:

Outcomes assessors will be masked to the intervention condition at follow-up assessment time points.

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Nov 5, 2020

Actual Primary Completion Date :

Sep 17, 2021

Actual Study Completion Date :

Sep 17, 2021

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

Referral Rate [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 referrals.

Secondary Outcome Measures

Cost Effectiveness [At Baseline phone visit]
The following information on the incremental cost effectiveness of Screening Wizard will be gathered from the electronic health record (EHR) and the Child and Adolescent Service Assessment (CASA): (a) the direct costs of the intervention, including intervention (labor, equipment, supplies, facilities); (b) the total treatment as usual service use and expense for each participant the study arm using HER and CASA data; and (c) family costs (out-of-pocket expenses, parent missed time from work).
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 make within 1 month following the completion of the Baseline phone assessment]
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?; How satisfied are you with the amount of help you received?; Have the services you received helped you to deal more effectively with your problems?". The response options include: No, definitely not; No, I don't think so; Yes, I think so; Yes, definitely.
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]
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. Questions from sub-domains were chosen to tailor the questioning to this particular intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 26 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Youth aged 12-26yo
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	UPMC Center for Adolescent and Young Adult Health	Pittsburgh	Pennsylvania	United States	15213
2	Kids Plus Pediatrics	Pittsburgh	Pennsylvania	United States	15217