Depression, Suicidal Ideation
Conditions
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). 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.
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).
Interventions
BEHAVIORALScreening Wizard
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.
Sponsors
Kaiser Foundation Research Institute
National Institute of Mental Health (NIMH)
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Outcome assessors will be masked to the intervention condition at follow-up assessment timepoints.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 26 Years
Healthy volunteers
No
Inclusion criteria
* Youth aged 12-26 yo * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Personalized Referral | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Utilized the Screening Wizard Application | Baseline (phone) visit | 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. |
| Service Use (Number of Participants at Baseline) | At Baseline phone visit | 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. |
| Service Use (Number of Participants at 4 Week Follow-up) | Week 4 follow-up after 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. |
| Usability & Satisfaction | 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 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. |
| Cost Analysis: Cost of Screening Wizard Intervention at Baseline | At Baseline | An overall average of the cost of implementing the Screening Wizard intervention (including labor, equipment, supplies, facilitates) will be estimated at Baseline. |
| Service Use (Number of Participants at 12 Week Follow-up) | Week 12 follow up after 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. |
Countries
United States
Participant flow
Pre-assignment details
Some participants were enrolled into the TAU arm prior to converting from a stepped wedge design to an open design.
Participants by arm
| Arm | Count |
|---|---|
| Screening Wizard 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.
Screening Wizard: 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. | 27 |
| Treatment As Usual (TAU) Youth and parents randomized to TAU will still be approached to take the Screening Wizard questions, but the resulting report will not be relayed to the treating physician. Imminent suicidality will still be addressed per the practices standard of care. In the TAU condition, the list of depression and suicidality items and based on practice preferences, standard of care substance use items, will be printed and handed to the providers. The handout will not include the decision support tool to guide referrals. | 26 |
| Total | 53 |
Baseline characteristics
| Characteristic | Total | Screening Wizard | Treatment As Usual (TAU) |
|---|---|---|---|
| Age, Categorical <=18 years | 36 Participants | 10 Participants | 26 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 17 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 26 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 3 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 32 Participants | 19 Participants | 13 Participants |
| Region of Enrollment United States | 53 participants | 27 participants | 26 participants |
| Sex/Gender, Customized Gender Female | 29 Participants | 17 Participants | 12 Participants |
| Sex/Gender, Customized Gender Female to Male Transgender | 2 Participants | 2 Participants | 0 Participants |
| Sex/Gender, Customized Gender Male | 21 Participants | 7 Participants | 14 Participants |
| Sex/Gender, Customized Gender Male to Female Transgender | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 26 |
| other Total, other adverse events | 0 / 27 | 0 / 26 |
| serious Total, serious adverse events | 0 / 27 | 0 / 26 |
Outcome results
Primary
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.
Time frame: Baseline (in office) visit
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Screening Wizard | Personalized Referral | Recommend referral to specialty depression clinic to evaluate suicidality | Disagree with recommendation | 0 Recommendations |
| Screening Wizard | Personalized Referral | All recommendations combined | Disagree with recommendation | 11 Recommendations |
| Screening Wizard | Personalized Referral | Substance use referral recommendation | Agree with recommendation | 0 Recommendations |
| Screening Wizard | Personalized Referral | Conduct a safety plan assessment recommendation | Agree with recommendation | 0 Recommendations |
| Screening Wizard | Personalized Referral | Substance use referral recommendation | Disagree with recommendation | 1 Recommendations |
| Screening Wizard | Personalized Referral | Watchful Waiting recommendation | Disagree with recommendation | 2 Recommendations |
| Screening Wizard | Personalized Referral | No treatment needed, rescreen if concern for non-disclosure recommendation | Agree with recommendation | 10 Recommendations |
| Screening Wizard | Personalized Referral | Conduct a safety plan assessment recommendation | Disagree with recommendation | 5 Recommendations |
| Screening Wizard | Personalized Referral | No treatment needed, rescreen if concern for non-disclosure recommendation | Disagree with recommendation | 0 Recommendations |
| Screening Wizard | Personalized Referral | All recommendations combined | Agree with recommendation | 22 Recommendations |
| Screening Wizard | Personalized Referral | Tobacco counseling recommendation | Agree with recommendation | 0 Recommendations |
| Screening Wizard | Personalized Referral | Refer to embedded therapist recommendation | Agree with recommendation | 1 Recommendations |
| Screening Wizard | Personalized Referral | Tobacco counseling recommendation | Disagree with recommendation | 1 Recommendations |
| Screening Wizard | Personalized Referral | Ask parent further questions recommendation | Agree with recommendation | 1 Recommendations |
| Screening Wizard | Personalized Referral | Refer to severe anxiety clinic recommendation | Agree with recommendation | 1 Recommendations |
| Screening Wizard | Personalized Referral | Refer to embedded therapist recommendation | Disagree with recommendation | 2 Recommendations |
| Screening Wizard | Personalized Referral | Refer to severe anxiety clinic recommendation | Disagree with recommendation | 0 Recommendations |
| Screening Wizard | Personalized Referral | Watchful Waiting recommendation | Agree with recommendation | 8 Recommendations |
| Screening Wizard | Personalized Referral | Refer to mania clinic recommendation | Agree with recommendation | 0 Recommendations |
| Screening Wizard | Personalized Referral | Recommend referral to specialty depression clinic to evaluate suicidality | Agree with recommendation | 1 Recommendations |
| Screening Wizard | Personalized Referral | Refer to mania clinic recommendation | Disagree with recommendation | 0 Recommendations |
| Screening Wizard | Personalized Referral | Ask parent further questions recommendation | Disagree with recommendation | 0 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | Refer to mania clinic recommendation | Disagree with recommendation | 1 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | All recommendations combined | Disagree with recommendation | 18 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | Watchful Waiting recommendation | Agree with recommendation | 10 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | Watchful Waiting recommendation | Disagree with recommendation | 0 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | Ask parent further questions recommendation | Agree with recommendation | 0 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | Ask parent further questions recommendation | Disagree with recommendation | 0 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | Conduct a safety plan assessment recommendation | Agree with recommendation | 0 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | Conduct a safety plan assessment recommendation | Disagree with recommendation | 12 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | Refer to embedded therapist recommendation | Agree with recommendation | 2 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | Refer to embedded therapist recommendation | Disagree with recommendation | 4 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | Recommend referral to specialty depression clinic to evaluate suicidality | Agree with recommendation | 0 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | Recommend referral to specialty depression clinic to evaluate suicidality | Disagree with recommendation | 0 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | Substance use referral recommendation | Agree with recommendation | 0 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | Substance use referral recommendation | Disagree with recommendation | 0 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | No treatment needed, rescreen if concern for non-disclosure recommendation | Agree with recommendation | 3 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | No treatment needed, rescreen if concern for non-disclosure recommendation | Disagree with recommendation | 0 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | Tobacco counseling recommendation | Agree with recommendation | 0 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | Tobacco counseling recommendation | Disagree with recommendation | 1 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | Refer to severe anxiety clinic recommendation | Agree with recommendation | 0 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | Refer to severe anxiety clinic recommendation | Disagree with recommendation | 0 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | Refer to mania clinic recommendation | Agree with recommendation | 0 Recommendations |
| Treatment As Usual (TAU) | Personalized Referral | All recommendations combined | Agree with recommendation | 15 Recommendations |
p-value: 0.083Chi-squared
Secondary
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.
Time frame: At Baseline
Population: All 27 participants enrolled engaged in using Screening Wizard intervention.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Screening Wizard | Cost Analysis: Cost of Screening Wizard Intervention at Baseline | 160.34 dollars per participant |
Secondary
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.
Time frame: Baseline (phone) visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screening Wizard | Number of Participants Who Utilized the Screening Wizard Application | 27 Participants |
| Treatment As Usual (TAU) | Number of Participants Who Utilized the Screening Wizard Application | 26 Participants |
p-value: >0.99Chi-squared
Secondary
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.
Time frame: Week 12 follow up after Baseline
Population: 26/27 Screening Wizard intervention participants completed CASA assessment and all Treatment As Usual participants completed CASA assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Screening Wizard | Service Use (Number of Participants at 12 Week Follow-up) | Use school services | 5 Participants |
| Screening Wizard | Service Use (Number of Participants at 12 Week Follow-up) | Use legal services | 0 Participants |
| Screening Wizard | Service Use (Number of Participants at 12 Week Follow-up) | Use outpatient services | 13 Participants |
| Screening Wizard | Service Use (Number of Participants at 12 Week Follow-up) | Use inpatient services | 0 Participants |
| Screening Wizard | Service Use (Number of Participants at 12 Week Follow-up) | Use medications | 11 Participants |
| Screening Wizard | Service Use (Number of Participants at 12 Week Follow-up) | Use ER services | 0 Participants |
| Treatment As Usual (TAU) | Service Use (Number of Participants at 12 Week Follow-up) | Use medications | 4 Participants |
| Treatment As Usual (TAU) | Service Use (Number of Participants at 12 Week Follow-up) | Use outpatient services | 7 Participants |
| Treatment As Usual (TAU) | Service Use (Number of Participants at 12 Week Follow-up) | Use school services | 3 Participants |
| Treatment As Usual (TAU) | Service Use (Number of Participants at 12 Week Follow-up) | Use ER services | 0 Participants |
| Treatment As Usual (TAU) | Service Use (Number of Participants at 12 Week Follow-up) | Use legal services | 1 Participants |
| Treatment As Usual (TAU) | Service Use (Number of Participants at 12 Week Follow-up) | Use inpatient services | 0 Participants |
Secondary
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.
Time frame: Week 4 follow-up after Baseline
Population: All Screening WIzard intervention participants responded to 4 week CASA assessment and 25/26 Treatment As Usual participants responded to 4 week CASA assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Screening Wizard | Service Use (Number of Participants at 4 Week Follow-up) | Use legal services | 0 Participants |
| Screening Wizard | Service Use (Number of Participants at 4 Week Follow-up) | Use outpatient services | 14 Participants |
| Screening Wizard | Service Use (Number of Participants at 4 Week Follow-up) | Use inpatient services | 0 Participants |
| Screening Wizard | Service Use (Number of Participants at 4 Week Follow-up) | Use ER services | 0 Participants |
| Screening Wizard | Service Use (Number of Participants at 4 Week Follow-up) | Use medications | 11 Participants |
| Screening Wizard | Service Use (Number of Participants at 4 Week Follow-up) | Use school services | 5 Participants |
| Treatment As Usual (TAU) | Service Use (Number of Participants at 4 Week Follow-up) | Use medications | 3 Participants |
| Treatment As Usual (TAU) | Service Use (Number of Participants at 4 Week Follow-up) | Use school services | 4 Participants |
| Treatment As Usual (TAU) | Service Use (Number of Participants at 4 Week Follow-up) | Use ER services | 0 Participants |
| Treatment As Usual (TAU) | Service Use (Number of Participants at 4 Week Follow-up) | Use legal services | 0 Participants |
| Treatment As Usual (TAU) | Service Use (Number of Participants at 4 Week Follow-up) | Use inpatient services | 0 Participants |
| Treatment As Usual (TAU) | Service Use (Number of Participants at 4 Week Follow-up) | Use outpatient services | 6 Participants |
Secondary
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.
Time frame: At Baseline phone visit
Population: All participants in both arms responded to CASA questions for Baseline assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Screening Wizard | Service Use (Number of Participants at Baseline) | Use outpatient services | 19 Participants |
| Screening Wizard | Service Use (Number of Participants at Baseline) | Use school services | 14 Participants |
| Screening Wizard | Service Use (Number of Participants at Baseline) | Use ER services | 2 Participants |
| Screening Wizard | Service Use (Number of Participants at Baseline) | Use legal services | 1 Participants |
| Screening Wizard | Service Use (Number of Participants at Baseline) | Use inpatient services | 3 Participants |
| Screening Wizard | Service Use (Number of Participants at Baseline) | Use medications | 15 Participants |
| Treatment As Usual (TAU) | Service Use (Number of Participants at Baseline) | Use inpatient services | 1 Participants |
| Treatment As Usual (TAU) | Service Use (Number of Participants at Baseline) | Use outpatient services | 6 Participants |
| Treatment As Usual (TAU) | Service Use (Number of Participants at Baseline) | Use legal services | 0 Participants |
| Treatment As Usual (TAU) | Service Use (Number of Participants at Baseline) | Use school services | 6 Participants |
| Treatment As Usual (TAU) | Service Use (Number of Participants at Baseline) | Use medications | 6 Participants |
| Treatment As Usual (TAU) | Service Use (Number of Participants at Baseline) | Use ER services | 2 Participants |
Secondary
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.
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.
Population: Out of the 27 participants in the Screening Wizard arm, only 22 answered the satisfaction question at the exit interview. No statistical analysis completed because there is no comparison group.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Screening Wizard | Usability & Satisfaction | No, definitely not | 0 Participants |
| Screening Wizard | Usability & Satisfaction | No, I don't think so | 6 Participants |
| Screening Wizard | Usability & Satisfaction | Yes, I think so | 12 Participants |
| Screening Wizard | Usability & Satisfaction | Yes, definitely | 4 Participants |
Secondary
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.
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.
Population: Out of the 27 participants in the Screening Wizard arm, only 19 answered the questions regarding satisfaction with technical components at the exit interview. No statistical analysis completed because there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Screening Wizard | Usability & Satisfaction | Overall, I am satisfied with how easy it is to use Screening Wizard | 6.2 score on a scale | Standard Deviation 1.3 |
| Screening Wizard | Usability & Satisfaction | The information such as online help, on-screen messages, and other documentation, provided was clear | 6.2 score on a scale | Standard Deviation 1 |
| Screening Wizard | Usability & Satisfaction | I liked interacting with the Screening Wizard app | 5.7 score on a scale | Standard Deviation 1.2 |
| Screening Wizard | Usability & Satisfaction | I needed to learn a lot of things before I could get going with the Screening Wizard | 1.5 score on a scale | Standard Deviation 0.7 |