Clinical trial NCT03985813: Screening Wizard, Component 1 of iCHART (Integrated Care to Help At-Risk Teens)-Feasibility/Pilot Phase
Official title: Screening Wizard, Component 1 of iCHART (Integrated Care to Help At-Risk Teens)-Feasibility/Pilot Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Suicidal Ideation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Kaiser Foundation Research Institute
name: National Institute of Mental Health (NIMH)
First posted: 2019-06-14
Enrollment: 53
Sex: ALL
Minimum age (years): 12
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Personalized Referral
timeFrame: Baseline (in office) visit
Secondary outcomes:
measure: Number of Participants Who Utilized the Screening Wizard Application
timeFrame: Baseline (phone) visit
measure: Service Use (Number of Participants at Baseline)
timeFrame: At Baseline phone visit
measure: Service Use (Number of Participants at 4 Week Follow-up)
timeFrame: Week 4 follow-up after Baseline
measure: Service Use (Number of Participants at 12 Week Follow-up)
timeFrame: Week 12 follow up after Baseline
measure: Usability & Satisfaction
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 assessment.
measure: Usability & Satisfaction
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 assessment.
measure: Cost Analysis: Cost of Screening Wizard Intervention at Baseline
timeFrame: At Baseline
Other outcomes:
Locations:
city: Cranberry Township
country: United States
facility: Children's Community Pediatrics (CCP-Bass Wolfson Cranberry) of Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh Department of Neurology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Primary Care Center (PCC) of Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Center for Adolescent and Young Adult Health
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Oliver Lindhiem, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Ana Radovic, MD
role: STUDY_DIRECTOR
References: