Trial Outcomes & Findings for Screening Wizard- Phase 2 (NCT NCT04646369)
NCT ID: NCT04646369
Last Updated: 2022-10-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Baseline (in office) visit
Results posted on
2022-10-07
Participant Flow
Participant milestones
| Measure |
"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
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
38
|
39
|
|
Overall Study
COMPLETED
|
23
|
38
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Screening Wizard- Phase 2
Baseline characteristics by cohort
| Measure |
"Screening as Usual"
n=23 Participants
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
|
Screening Wizard 2.0
n=38 Participants
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.
|
Screening Wizard 2.0 + SOVA
n=39 Participants
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.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
16 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male to Female Transgender
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female to Male Transgender
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Non Binary/Queer
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (in office) visitPopulation: 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.
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.
Outcome measures
| Measure |
"Screening as Usual"
n=22 Participants
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
|
Screening Wizard 2.0
n=70 Participants
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.
|
|---|---|---|
|
Number of Participants Referred to Treatment
Drug or alcohol treatment services Referral
|
0 Participants
|
1 Participants
|
|
Number of Participants Referred to Treatment
Emergency department services Referral
|
0 Participants
|
0 Participants
|
|
Number of Participants Referred to Treatment
Family-based services Referral
|
0 Participants
|
1 Participants
|
|
Number of Participants Referred to Treatment
In-home services Referral
|
0 Participants
|
0 Participants
|
|
Number of Participants Referred to Treatment
Inpatient services Referral
|
0 Participants
|
0 Participants
|
|
Number of Participants Referred to Treatment
Intensive Outpatient Program Referral
|
0 Participants
|
1 Participants
|
|
Number of Participants Referred to Treatment
Outpatient psychotherapy/counseling Referral
|
4 Participants
|
19 Participants
|
|
Number of Participants Referred to Treatment
Partial hospitalization Referral
|
0 Participants
|
0 Participants
|
|
Number of Participants Referred to Treatment
Residential treatment facility Referral
|
0 Participants
|
0 Participants
|
|
Number of Participants Referred to Treatment
School-based services Referral
|
0 Participants
|
0 Participants
|
|
Number of Participants Referred to Treatment
Other Referral
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At Baseline visitPopulation: 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.
An overall average of the cost of implementing the Screening Wizard intervention (including labor, equipment, supplies, facilitates) will be estimated at Baseline.
Outcome measures
| Measure |
"Screening as Usual"
n=77 Participants
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
|
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.
|
|---|---|---|
|
Cost Analysis: Cost of Screening Wizard Intervention at Baseline
|
160.34 dollars per participant
Interval 81.54 to 198.88
|
—
|
SECONDARY outcome
Timeframe: 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 assessmentPopulation: 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.
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)
Outcome measures
| Measure |
"Screening as Usual"
n=38 Participants
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
|
Screening Wizard 2.0
n=39 Participants
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.
|
|---|---|---|
|
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
|
2.89 score on a scale
Standard Deviation 0.69
|
|
Usability & Satisfaction
How satisfied with the amount of help you received?
|
3.42 score on a scale
Standard Deviation 0.5
|
3.39 score on a scale
Standard Deviation 0.55
|
|
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
|
2.71 score on a scale
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: 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 assessmentPopulation: 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.
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.
Outcome measures
| Measure |
"Screening as Usual"
n=38 Participants
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
|
Screening Wizard 2.0
n=39 Participants
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.
|
|---|---|---|
|
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
|
6.5 score on a scale
Standard Deviation 0.83
|
|
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
|
6.37 score on a scale
Standard Deviation 1.13
|
|
Satisfaction With Technical Components
I liked interacting with the Screening Wizard app
|
5.81 score on a scale
Standard Deviation 1.38
|
5.68 score on a scale
Standard Deviation 1.3
|
|
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
|
1.35 score on a scale
Standard Deviation 0.95
|
Adverse Events
"Screening as Usual"
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Screening Wizard 2.0
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Screening Wizard 2.0 + SOVA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place