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OpenTrials
Completed

NCT Number: NCT04646369

Screening Wizard- Phase 2

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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Key information

Conditions

Depression Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Self-Injurious Behavior Suicidal Ideation Suicide

Age range

12 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kids Plus Pediatrics, Pittsburgh, Pennsylvania, United States

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About this study

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%)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

"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 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 + 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.

Primary outcomes

  1. Number of Participants Referred to Treatment

    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 outcomes

  1. Cost Analysis: Cost of Screening Wizard Intervention at Baseline

    Time frame: At Baseline visit

    An overall average of the cost of implementing the Screening Wizard intervention (including labor, equipment, supplies, facilitates) will be estimated at Baseline.

  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 made 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? (SCALE: No, definitely not-Yes, definitely/1-4)

    How satisfied are you with the amount of help you received? (SCALE: Very dissatisfied-Very satisfied/1-4)

    Have the services you received helped you to deal more effectively with your problems? (SCALE: Seemed to make things worse-Yes, a great deal/1-4)

  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. 4 Questions from sub-domains were chosen to tailor the questioning to this particular intervention.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Kaiser Foundation Research Institute
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 27, 2020
Registry last updated
Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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