DepressionNCT03985813

Screening Wizard, Component 1 of iCHART (Integrated Care to Help At-Risk Teens)-Feasibility/Pilot Phase

A study testing Screening Wizard in people with Depression and Suicidal Ideation, run by University of Pittsburgh at 4 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 12 to 26 years
Conditions the study is for: Depression, Suicidal Ideation
What is being tested?: Screening Wizard
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 4 sitesUnited States
Study dates: 13 Aug 2019to 15 Oct 2020
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
No healthy volunteers
Child, Adult

Who may be able to join

Youth aged 12-26 yo
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

4 sites in 1 country.

United States4 sites

Children's Community Pediatrics (CCP-Bass Wolfson Cranberry) of Children's Hospital of Pittsburgh of UPMC
Cranberry Township, Pennsylvania, 16066
Children's Hospital of Pittsburgh Department of Neurology
Pittsburgh, Pennsylvania, 15213
Children's Primary Care Center (PCC) of Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15213
UPMC Center for Adolescent and Young Adult Health
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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). Those parents and patients receiving SW will answer additional questions: adaptive screens developed in a previous NIMH study (MH100155) for suicidal risk, anxiety, and mania; perceived barriers; and preferences about treatment. SW generates recommendations for PCPs reflecting patient clinical needs and preferences.

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 that same visit.

This study utilized an open trial design. A stepped wedge design was originally proposed and efforts were made to adhere to this study design, however after a year of low recruitment and resultant recruitment sites pulling out the of the study, the overall study design was changed to an open trial. Additional recruitment sites were onboarded to the study and provided with the intervention arm in order to obtain feasibility data on the intervention components of the study. For reference a stepped wedge design involves the sequential random rollout of an intervention over two time periods. Following a baseline period in which no clusters (=practices) are exposed to the intervention, the crossover is typically in one direction, from control to intervention and continues until both of the clusters have crossed-over to receive the intervention, with observations taken from each cluster and at each time period.

Hypothesis: The use of Screening Wizard will increase the rate of personalized referrals experts in specialty mental health would provide, compared to Treatment as usual (TAU).

Conditions: Depression, Suicidal Ideation
Being tested: Screening Wizard
Medical subject headings: Depression, Suicidal Ideation

What participants receive

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

Screening WizardBehavioural
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.

Study groups in NCT03985813
Study group	Role	What they receive
Screening Wizard	Experimental	Youth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant 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. Receives: Behavioral: Screening Wizard

What is being measured

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

Personalized Referral
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 referral as recommended on intervention report.
This initial outcome has been modified as a result of the changes in study design.
Measured: Baseline (in office) visit

Secondary outcomes (7)

Number of Participants Who Utilized the Screening Wizard Application
Use of the technical components of Screening Wizard will be monitored. Utilization will be measured by the number and proportion of adolescents, parents, and providers who have engaged with the application over time.
Measured: Baseline (phone) visit
Service Use (Number of Participants at Baseline)
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm.
Measured: At Baseline phone visit
Service Use (Number of Participants at 4 Week Follow-up)
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm.
Measured: Week 4 follow-up after Baseline
Service Use (Number of Participants at 12 Week Follow-up)
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm.
Measured: Week 12 follow up after Baseline
Usability & Satisfaction
Satisfaction to Screening Wizard will be assessed through a question developed by investigators to understand experience with the program. The question investigators have adapted from literature reviews on satisfaction is: "If a friend were in need of a mental health referral, would you recommend Screening Wizard to him/her? The response options include: No, definitely not; No, I don't think so; Yes, I think so; Yes, definitely.
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.
Usability & Satisfaction
Satisfaction with the technical components of interventions will be assessed through 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. Another question about the need to learn new things before using the app was asked to be rated on a 1-5 scale, with 1= strongly disagree and 5= strongly agree.
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.
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

Timeline

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

13 Aug 201915 Oct 2020

First posted14 Jun 2019
Study start13 Aug 2019
Primary completion15 Oct 2020
Study completion15 Oct 2020

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: Not applicable
Intervention model: Single group
Model description: Ultimately, this study design was an open trial after unsuccessful attempts to maintain initial recruitment sites in the study. This study initially attempted to use a stepped wedge design, which involves the sequential random rollout of an intervention over 2 time periods. Following a baseline period in which no clusters (= practices) are exposed to the intervention, the crossover is typically in one direction, from control to intervention and continues until both of the clusters have crossed-over to receive the intervention, with observations taken from each cluster and at each time period.
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03985813
Sponsor's protocol ID: STUDY18110137
Other IDs: P50MH115838-02
Status last verified: Jul 2022
First submitted: 5 Jun 2019
Last updated: 15 Jul 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

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety

All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Screening Wizard, Component 1 of iCHART (Integrated Care to Help At-Risk Teens)-Feasibility/Pilot Phase
ClinicalTrials.gov ID: NCT03985813
Acronym / sponsor ID: STUDY18110137
Conditions: Depression, Suicidal Ideation
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: Kaiser Foundation Research Institute, National Institute of Mental Health (NIMH)
Study start: 13 Aug 2019 (actual)
Primary completion: 15 Oct 2020 (actual)
Study completion: 15 Oct 2020 (actual)
First posted: 14 Jun 2019 (actual)
Results: Posted 10 Nov 2021

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: The use of Screening Wizard will increase the rate of personalized referrals experts in specialty mental health would provide, compared to Treatment as usual (TAU).

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Ultimately, this study design was an open trial after unsuccessful attempts to maintain initial recruitment sites in the study. This study initially attempted to use a stepped wedge design, which involves the sequential random rollout of an intervention over 2 time periods. Following a baseline period in which no clusters (= practices) are exposed to the intervention, the crossover is typically in one direction, from control to intervention and continues until both of the clusters have crossed-over to receive the intervention, with observations taken from each cluster and at each time period.

Arm	Type	Receives
Screening Wizard	Experimental	Behavioral: Screening WizardYouth and parents receiving Screening Wizard will be screened for depression and suicidal risk within their pediatric primary care provider's office. Screening will be analyzed in real-time to produce a decision support tool meant 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.

Who may qualify

Ages: 12 to 26 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Youth aged 12-26 yo
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 WizardScreening 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

Primary outcome

Personalized Referral
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 referral as recommended on intervention report. This initial outcome has been modified as a result of the changes in study design.

7 secondary outcomes

Number of Participants Who Utilized the Screening Wizard Application
Time frame: Baseline (phone) visit
Service Use (Number of Participants at Baseline)
Time frame: At Baseline phone visit
Service Use (Number of Participants at 4 Week Follow-up)
Time frame: Week 4 follow-up after Baseline
Service Use (Number of Participants at 12 Week Follow-up)
Time frame: Week 12 follow up after Baseline
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.
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.
Cost Analysis: Cost of Screening Wizard Intervention at Baseline
Time frame: At Baseline

Results and safety

Results posted to the registry on 10 Nov 2021, 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 Wizard	27	27
Treatment As Usual (TAU)	26	26

Primary outcome: Personalized Referral

Time frame: Baseline (in office) visit. Count of units. Unit: Recommendations

Measure	Screening Wizard n = 27	Treatment As Usual (TAU) n = 26
All recommendations combined: Agree with recommendation	22	15
All recommendations combined: Disagree with recommendation	11	18
Watchful Waiting recommendation: Agree with recommendation	8	10
Watchful Waiting recommendation: Disagree with recommendation	2	0
Ask parent further questions recommendation: Agree with recommendation	1	0
Ask parent further questions recommendation: Disagree with recommendation	0	0
Conduct a safety plan assessment recommendation: Agree with recommendation	0	0
Conduct a safety plan assessment recommendation: Disagree with recommendation	5	12

Screening Wizard vs Treatment As Usual (TAU): p = 0.083, Chi-squared

Population analysed: The number analyzed for each row differs from overall number analyzed as each row is broken into subcategories of recommendations. Not all participants received a specific recommendation. TAU results are recommendations that would have been made based on Screening Wizard algorithm.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Over the 1 year and 1 month of data collection for the study, participants were assessed for adverse events at each timepoint (baseline, 4 week follow-up, 12 week follow-up). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Screening Wizard	0 of 27 (0%)	0 of 27 (0%)	0 of 27
Treatment As Usual (TAU)	0 of 26 (0%)	0 of 26 (0%)	0 of 26

Limitations and caveats (from the sponsor): The study design changed from a stepped wedge design to an open trial. As a feasibility trial, the study was not adequately powered to detect significant effects. In some cases, minor issues with the SW decision tree algorithm led to providers in the SW arm receiving guidance for a higher level of care than was necessary. It's possible that some documentation reviewed in the EHR was missing during the consensus and matching process between the EHR referral data and the SW report.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 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.

Related trials for Depression

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety

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, MD study director

University of Pittsburgh

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

Questions about this trial

What is this clinical trial studying?

A study testing Screening Wizard in people with Depression and Suicidal Ideation, run by University of Pittsburgh at 4 sites in United States.

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 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 10 Nov 2021). 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?

Personalized Referral (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 NCT03985813.

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 15 Jul 2022.