Screening Wizard- Phase 2

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-05

Study Completion Date

2021-09-17

Brief Summary

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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).

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Detailed Description

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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%)

Conditions

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Depression Suicidal Ideation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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"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.

Group Type ACTIVE_COMPARATOR

"screening as usual"

Intervention Type 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 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.

Group Type EXPERIMENTAL

Screening Wizard 2.0

Intervention Type 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 + 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.

Group Type EXPERIMENTAL

Screening Wizard 2.0 + SOVA

Intervention Type 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.

Interventions

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"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

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes