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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-13

Study Completion Date

2020-10-15

Brief Summary

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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.

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Detailed Description

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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

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Depression Suicidal Ideation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Outcome assessors will be masked to the intervention condition at follow-up assessment timepoints.

Study Groups

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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.

Group Type EXPERIMENTAL

Screening Wizard

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No