Depression, Suicidal Ideation
Conditions
Keywords
depression, anxiety, suicidal ideation, treatment, referral, screening
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). 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).
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%)
Interventions
BEHAVIORALscreening 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
BEHAVIORALScreening 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.
BEHAVIORALScreening 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.
Sponsors
Kaiser Foundation Research Institute
National Institute of Mental Health (NIMH)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessors will be masked to the intervention condition at follow-up assessment time points.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 26 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Referred to Treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Cost Analysis: Cost of Screening Wizard Intervention at Baseline | 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. |
| 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 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) |
| Satisfaction With Technical Components | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 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 | 23 |
| 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.
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. | 38 |
| 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.
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. | 39 |
| Total | 100 |
Baseline characteristics
| Characteristic | Screening as Usual | Screening Wizard 2.0 | Screening Wizard 2.0 + SOVA | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 15 Participants | 10 Participants | 29 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 23 Participants | 29 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 38 Participants | 37 Participants | 94 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 7 Participants | 10 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 7 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 16 Participants | 26 Participants | 21 Participants | 63 Participants |
| Sex/Gender, Customized Female | 16 Participants | 24 Participants | 27 Participants | 67 Participants |
| Sex/Gender, Customized Female to Male Transgender | 4 Participants | 3 Participants | 3 Participants | 10 Participants |
| Sex/Gender, Customized Male | 1 Participants | 3 Participants | 3 Participants | 7 Participants |
| Sex/Gender, Customized Male to Female Transgender | 1 Participants | 4 Participants | 2 Participants | 7 Participants |
| Sex/Gender, Customized Non Binary/Queer | 0 Participants | 3 Participants | 3 Participants | 6 Participants |
| Sex/Gender, Customized Other | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 38 | 0 / 39 |
| other Total, other adverse events | 0 / 23 | 0 / 38 | 0 / 39 |
| serious Total, serious adverse events | 0 / 23 | 0 / 38 | 0 / 39 |
Outcome results
Primary
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.
Time frame: Baseline (in office) visit
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Screening as Usual | Number of Participants Referred to Treatment | Partial hospitalization Referral | 0 Participants |
| Screening as Usual | Number of Participants Referred to Treatment | Drug or alcohol treatment services Referral | 0 Participants |
| Screening as Usual | Number of Participants Referred to Treatment | Emergency department services Referral | 0 Participants |
| Screening as Usual | Number of Participants Referred to Treatment | Family-based services Referral | 0 Participants |
| Screening as Usual | Number of Participants Referred to Treatment | In-home services Referral | 0 Participants |
| Screening as Usual | Number of Participants Referred to Treatment | Inpatient services Referral | 0 Participants |
| Screening as Usual | Number of Participants Referred to Treatment | Intensive Outpatient Program Referral | 0 Participants |
| Screening as Usual | Number of Participants Referred to Treatment | Outpatient psychotherapy/counseling Referral | 4 Participants |
| Screening as Usual | Number of Participants Referred to Treatment | Residential treatment facility Referral | 0 Participants |
| Screening as Usual | Number of Participants Referred to Treatment | School-based services Referral | 0 Participants |
| Screening as Usual | Number of Participants Referred to Treatment | Other Referral | 1 Participants |
| Screening Wizard 2.0 | Number of Participants Referred to Treatment | Residential treatment facility Referral | 0 Participants |
| Screening Wizard 2.0 | Number of Participants Referred to Treatment | Intensive Outpatient Program Referral | 1 Participants |
| Screening Wizard 2.0 | Number of Participants Referred to Treatment | Drug or alcohol treatment services Referral | 1 Participants |
| Screening Wizard 2.0 | Number of Participants Referred to Treatment | Other Referral | 2 Participants |
| Screening Wizard 2.0 | Number of Participants Referred to Treatment | Emergency department services Referral | 0 Participants |
| Screening Wizard 2.0 | Number of Participants Referred to Treatment | Outpatient psychotherapy/counseling Referral | 19 Participants |
| Screening Wizard 2.0 | Number of Participants Referred to Treatment | Family-based services Referral | 1 Participants |
| Screening Wizard 2.0 | Number of Participants Referred to Treatment | Partial hospitalization Referral | 0 Participants |
| Screening Wizard 2.0 | Number of Participants Referred to Treatment | In-home services Referral | 0 Participants |
| Screening Wizard 2.0 | Number of Participants Referred to Treatment | School-based services Referral | 0 Participants |
| Screening Wizard 2.0 | Number of Participants Referred to Treatment | Inpatient services Referral | 0 Participants |
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 visit
Population: Only participants who engaged in the Screening Wizard intervention are able to be analyzed for cost estimate. Both the Screening Wizard 2.0 Report Group arm and the Screening Wizard + SOVA Arm are included in this analysis. The intervention cost is only calculated for the intervention itself, not in the context of use of other services such as SOVA or those in the control group who may access other services.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Screening as Usual | Cost Analysis: Cost of Screening Wizard Intervention at Baseline | 160.34 dollars per participant |
Secondary
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.
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
Population: All participants who reported to usability \& satisfaction questions were analyzed from the 2 arms that used the Screening Wizard intervention. Note=TAU participants did not receive the items because they did not receive the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Screening as Usual | Satisfaction With Technical Components | Overall, I am satisfied with how easy it is to use Screening Wizard | 6.41 score on a scale | Standard Deviation 0.84 |
| Screening as Usual | Satisfaction With Technical Components | Information such as online help, on-screen messages, other documentation...was clear | 6.13 score on a scale | Standard Deviation 1.45 |
| Screening as Usual | Satisfaction With Technical Components | I liked interacting with the Screening Wizard app | 5.81 score on a scale | Standard Deviation 1.38 |
| Screening as Usual | Satisfaction With Technical Components | needed to learn a lot of things before I could get going with the Screening Wizard | 1.22 score on a scale | Standard Deviation 0.49 |
| Screening Wizard 2.0 | Satisfaction With Technical Components | needed to learn a lot of things before I could get going with the Screening Wizard | 1.35 score on a scale | Standard Deviation 0.95 |
| Screening Wizard 2.0 | Satisfaction With Technical Components | Overall, I am satisfied with how easy it is to use Screening Wizard | 6.5 score on a scale | Standard Deviation 0.83 |
| Screening Wizard 2.0 | Satisfaction With Technical Components | I liked interacting with the Screening Wizard app | 5.68 score on a scale | Standard Deviation 1.3 |
| Screening Wizard 2.0 | Satisfaction With Technical Components | Information such as online help, on-screen messages, other documentation...was clear | 6.37 score on a scale | Standard Deviation 1.13 |
Secondary
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)
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: All participants who reported to usability \& satisfaction questions were analyzed from the 2 arms that used the Screening Wizard intervention. Note=Screening As Usual/Treatment As Usual (TAU) participants did not receive the items because they did not receive the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Screening as Usual | Usability & Satisfaction | If a friend needed to talk to provider about emotional or mental health concerns would you recommend | 2.88 score on a scale | Standard Deviation 0.7 |
| Screening as Usual | Usability & Satisfaction | How satisfied with the amount of help you received? | 3.42 score on a scale | Standard Deviation 0.5 |
| Screening as Usual | Usability & Satisfaction | Have the services you received helped you to deal more effectively with your problems? | 2.94 score on a scale | Standard Deviation 0.76 |
| Screening Wizard 2.0 | Usability & Satisfaction | If a friend needed to talk to provider about emotional or mental health concerns would you recommend | 2.89 score on a scale | Standard Deviation 0.69 |
| Screening Wizard 2.0 | Usability & Satisfaction | How satisfied with the amount of help you received? | 3.39 score on a scale | Standard Deviation 0.55 |
| Screening Wizard 2.0 | Usability & Satisfaction | Have the services you received helped you to deal more effectively with your problems? | 2.71 score on a scale | Standard Deviation 0.75 |