Ignite Creation Date:
2024-05-06 @ 1:21 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT04000399
Status:
COMPLETED
Last Update Posted:
2022-08-08
First Post:
2019-06-24
Brief Title:
BRITEPath Component 3 of iCHART Integrated Care to Help At-Risk Teens
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
BRITEPath Component 3 of iCHART Integrated Care to Help At-Risk Teens
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
BRITEPath BP aims to support co-located mental health clinicians in the development of a high quality effective and personalized safety plan for referred patients who screen positive for depression andor suicidal ideation
BRITEPath utilizes BRITE a safety planning and emotion regulation app that is loaded on the patients smart phone and has previously been shown to be well accepted and to reduce suicide attempts compared to usual care in psychiatric inpatients HR 049 To support mental health clinicians in the development of effective safety plans study investigators will develop Guide2Brite G2B which provides step-by-step instructions for the mental health clinician on how to populate BRITE onto the patients smartphone and BRITEBoard a clinician dashboard that tracks patient symptoms app use and rating on helpfulness of different interventions assessed through BRITE
BRITEPath utilizes BRITE a safety planning and emotion regulation app that is loaded on the patients smart phone and has previously been shown to be well accepted and to reduce suicide attempts compared to usual care in psychiatric inpatients HR 049 To support mental health clinicians in the development of effective safety plans study investigators will develop Guide2Brite G2B which provides step-by-step instructions for the mental health clinician on how to populate BRITE onto the patients smartphone and BRITEBoard a clinician dashboard that tracks patient symptoms app use and rating on helpfulness of different interventions assessed through BRITE
Detailed Description:
Delivery of Interventions
BRITEPath has 3 components1 BRITE an emotion regulation and safety planning phone app that is delivered by a co-located mental health MH clinician to adolescents at the time of their first therapy appointment 2 Guide2Brite which will guide the co-located MH clinician in working with the adolescent to population content onto BRITE and 3 BRITEBoard which is a clinician dashboard delivered to the MH clinician and PCP
Assignment of Interventions
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 As a result of the change there are some TAU participants included in this 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
Study investigators will pilot BRITEPath in community pediatric and mental health practices using a stepped wedge design n 50 adolescents
Hypothesis The use of BRITEPath will decrease depressive symptoms distress and suicidality any self-injurious ideation urges or behavior as well as improve overall functioning compared to TAU
Of note Study investigators initially intended to do a cost analysis as a secondary outcome measure but it was later decided that the analysis will not be done in this pilot phase of testing and will instead be completed during the Phase 2 RCT
BRITEPath has 3 components1 BRITE an emotion regulation and safety planning phone app that is delivered by a co-located mental health MH clinician to adolescents at the time of their first therapy appointment 2 Guide2Brite which will guide the co-located MH clinician in working with the adolescent to population content onto BRITE and 3 BRITEBoard which is a clinician dashboard delivered to the MH clinician and PCP
Assignment of Interventions
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 As a result of the change there are some TAU participants included in this 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
Study investigators will pilot BRITEPath in community pediatric and mental health practices using a stepped wedge design n 50 adolescents
Hypothesis The use of BRITEPath will decrease depressive symptoms distress and suicidality any self-injurious ideation urges or behavior as well as improve overall functioning compared to TAU
Of note Study investigators initially intended to do a cost analysis as a secondary outcome measure but it was later decided that the analysis will not be done in this pilot phase of testing and will instead be completed during the Phase 2 RCT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50MH115838-02 | NIH | None | httpsreporternihgovquickSearchP50MH115838-02 |