DepressionNCT04646369

Screening Wizard- Phase 2

A study testing "screening as usual", Screening Wizard 2.0 and Screening Wizard 2.0 + SOVA in people with Depression and Suicidal Ideation, run by University of Pittsburgh at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 to 26 yearsHealthy volunteers can take part
Conditions the study is for: Depression, Suicidal Ideation
What is being tested?: "screening as usual", Screening Wizard 2.0 and Screening Wizard 2.0 + SOVA
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 2 sitesUnited States
Study dates: 5 Nov 2020to 17 Sep 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 26 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Youth aged 12-26yo
Biological or adoptive parent is willing to provide informed consent for teen to participate
Youth speaks and understands English

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

UPMC Center for Adolescent and Young Adult Health
Pittsburgh, Pennsylvania, 15213
Kids Plus Pediatrics
Pittsburgh, Pennsylvania, 15217

Other trials in United States

About this study

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

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).

Read the 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%)

Conditions: Depression, Suicidal Ideation
Being tested: "screening as usual", Screening Wizard 2.0, Screening Wizard 2.0 + SOVA
Keywords: depression, anxiety, suicidal ideation, treatment, referral, screening
Medical subject headings: Depression, Suicidal Ideation, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

"screening as usual"Behavioural
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 2.0Behavioural
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 + SOVABehavioural
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.

Study groups in NCT04646369
Study group	Role	What they receive
"screening as usual"	Active comparator	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. Receives: Behavioral: "screening as usual"
Screening Wizard 2.0	Experimental	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. Receives: Behavioral: Screening Wizard 2.0
Screening Wizard 2.0 + SOVA	Experimental	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. Receives: Behavioral: Screening Wizard 2.0 + SOVA

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Referred to Treatment
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.
Measured: Baseline (in office) visit

Secondary outcomes (3)

Cost Analysis: Cost of Screening Wizard Intervention at Baseline
An overall average of the cost of implementing the Screening Wizard intervention (including labor, equipment, supplies, facilitates) will be estimated at Baseline.
Measured: At Baseline visit
Usability & Satisfaction
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)
Measured: 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 With Technical Components
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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 202017 Sep 2021

First posted27 Nov 2020
Study start5 Nov 2020
Primary completion17 Sep 2021
Study completion17 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04646369
Sponsor's protocol ID: STUDY20060325
Other IDs: P50MH115838-02
Status last verified: Oct 2022
First submitted: 20 Nov 2020
Last updated: 7 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Center for Enhancing Treatment & Utilization for Depression and Emergent Suicidality Phase 2-Study 1-Screening Wizard
ClinicalTrials.gov ID: NCT04646369
Acronym / sponsor ID: STUDY20060325
Conditions: Depression, Suicidal Ideation
Keywords: depression, anxiety, suicidal ideation, treatment, referral, screening
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: Kaiser Foundation Research Institute, National Institute of Mental Health (NIMH)
Study start: 5 Nov 2020 (actual)
Primary completion: 17 Sep 2021 (actual)
Study completion: 17 Sep 2021 (actual)
First posted: 27 Nov 2020 (actual)
Results: Posted 27 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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")

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
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.

Arm	Type	Receives
"screening as usual"	Active comparator	Behavioral: "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.
Screening Wizard 2.0	Experimental	Behavioral: Screening Wizard 2.0Participants 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.
Screening Wizard 2.0 + SOVA	Experimental	Behavioral: Screening Wizard 2.0 + SOVAParticipants 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.

Who may qualify

Ages: 12 to 26 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Youth aged 12-26yo
Biological or adoptive parent is willing to provide informed consent for teen to participate
Youth speaks and understands English

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
"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	Behavioural	"screening as usual"
Screening Wizard 2.0Screening 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.	Behavioural	Screening Wizard 2.0
Screening Wizard 2.0 + SOVAScreening 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.	Behavioural	Screening Wizard 2.0 + SOVA

Primary outcome

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.

3 secondary outcomes

Cost Analysis: Cost of Screening Wizard Intervention at Baseline
Time frame: At Baseline visit
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 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

Results and safety

Results posted to the registry on 27 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
"Screening as Usual"	23	23
Screening Wizard 2.0	38	38
Screening Wizard 2.0 + SOVA	39	39

Primary outcome: Number of Participants Referred to Treatment

Time frame: Baseline (in office) visit. Count of participants. Unit: Participants

Measure	"Screening as Usual" n = 22	Screening Wizard 2.0 n = 70
Drug or alcohol treatment services Referral	0	1
Emergency department services Referral	0	0
Family-based services Referral	0	1
In-home services Referral	0	0
Inpatient services Referral	0	0
Intensive Outpatient Program Referral	0	1
Outpatient psychotherapy/counseling Referral	4	19
Partial hospitalization Referral	0	0

Population analysed: 92 of 100 participants had documentation or an accessible electronic medical record to review referrals made following screening wizard report. Note-Screening Wizard arm (N=38) and Screening Wizard + Sova arm (N=39) are combined because both arms received same Screening Wizard intervention but the 3rd Arm also received SOVA. Data was reviewed and entered from the electronic health record based on referrals made by pediatric providers at time the intervention was implemented.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: participants were assessed for adverse events at each timepoint (baseline and 12 week follow-up). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
"Screening as Usual"	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Screening Wizard 2.0	0 of 38 (0%)	0 of 38 (0%)	0 of 38
Screening Wizard 2.0 + SOVA	0 of 39 (0%)	0 of 39 (0%)	0 of 39

Limitations and caveats (from the sponsor): The small sample limited the ability to detect statistical significance and practice sites had significant involvement from the research team. Both of these factors limit the generalizability of the results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Oliver Lindhiem, PhD principal investigator

University of Pittsburgh

Ana Radovic study director

University of Pittsburgh

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Referred to Treatment (time frame: Baseline (in office) visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04646369.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.