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Screening Wizard- Phase 2

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ClinicalTrials.gov Identifier: NCT04646369
Recruitment Status : Recruiting
First Posted : November 27, 2020
Last Update Posted : November 27, 2020
Sponsor:
Collaborators:
Kaiser Foundation Research Institute
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Oliver Lindhiem, University of Pittsburgh

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 Not Applicable

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 patient satisfaction compared to "screening as usual" (SW satisfaction > "screening as usual" satisfaction)

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%)

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : November 5, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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.




Primary Outcome Measures :
  1. Referral Rate [ Time Frame: 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 :
  1. Cost Effectiveness [ Time Frame: 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).

  2. Usability & Satisfaction [ 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 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.

  3. Satisfaction with Technical Components [ 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 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04646369


Contacts
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Contact: Brandie George-Milford, MA 412-246-5629 georgeba2@upmc.edu

Locations
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United States, Pennsylvania
Children's Community Pediatrics (CCP- Bass Wolfson Cranberry) of Children's Hospital of Pittsburgh of UPMC Not yet recruiting
Cranberry Township, Pennsylvania, United States, 16066
Contact: Brian Czervionke, MD    724-776-4433      
Children's Hospital of Pittsburgh Department of Neurology Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Yoshi Sogawa, MD    412-692-5520    yoshimi.sogawa@chp.edu   
Contact: Jesus Villamizar, MD    412-692-5520    jesus.villamizar@chp.edu   
Sub-Investigator: Yoshi Sogawa, MD         
Children's Primary Care Center (PCC) of Children's Hospital of Pittsburgh UPMC Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Alexjandrao Alexjandrao, MD    412-692-6000      
UPMC Center for Adolescent and Young Adult Health Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Ana Radovic, MD    412-692-6677    Ana.Radovic@chp.edu   
Sponsors and Collaborators
University of Pittsburgh
Kaiser Foundation Research Institute
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Oliver Lindhiem, PhD University of Pittsburgh
Study Director: Ana Radovic University of Pittsburgh
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Responsible Party: Oliver Lindhiem, Associate Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04646369    
Other Study ID Numbers: STUDY20060325
P50MH115838-02 ( U.S. NIH Grant/Contract )
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oliver Lindhiem, University of Pittsburgh:
depression
anxiety
suicidal ideation
treatment
referral
screening
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Suicidal Ideation
Behavioral Symptoms
Mood Disorders
Mental Disorders
Suicide
Self-Injurious Behavior