Clinical trial NCT04646369: Screening Wizard- Phase 2
Official title: The Center for Enhancing Treatment & Utilization for Depression and Emergent Suicidality Phase 2-Study 1-Screening Wizard
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Suicidal Ideation
Keywords: depression
anxiety
suicidal ideation
treatment
referral
screening
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Kaiser Foundation Research Institute
name: National Institute of Mental Health (NIMH)
First posted: 2020-11-27
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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%)

Eligibility 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.

Primary outcomes:
measure: Number of Participants Referred to Treatment
timeFrame: Baseline (in office) visit
Secondary outcomes:
measure: Cost Analysis: Cost of Screening Wizard Intervention at Baseline
timeFrame: At Baseline visit
measure: Usability & Satisfaction
timeFrame: 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
measure: Satisfaction With Technical Components
timeFrame: 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
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Center for Adolescent and Young Adult Health
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Kids Plus Pediatrics
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Oliver Lindhiem, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Ana Radovic
role: STUDY_DIRECTOR
References: