Ignite Creation Date:
2024-07-17 @ 11:18 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476886
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-03
First Post:
2024-06-11
Brief Title:
Intensive Crisis Intervention
Sponsor:
Jennifer Hughes
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
Intensive Crisis Intervention ICI for Adolescent Suicidal Behavior
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
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:
ICI
Brief Summary:
The studys purpose is to improve the clinical management of severe crises experienced by youth with psychiatric disorders by examining a brief evidence-based alternative to inpatient psychiatric care
Detailed Description:
The objective of this study is to refine and test Intensive Crisis Intervention ICI a brief evidence-based treatment that incorporates Family TherapyParent Training Cognitive Behavioral Therapy and Motivational Interviewing to target family functioning in reducing adolescent suicidal behavior The projects main goal is to examine feasibility acceptability research implementation procedures and preliminary effectiveness of ICI using a mixed-methods approach The investigators will utilize the extensive catchment area of Nationwide Childrens Hospital Behavioral Health NCH-BH to complete this work NCH-BH has a Youth Crisis Stabilization Unit YCSU in which ICI can be implemented and compared with outcomes from a traditional adolescent psychiatric inpatient unit Adolescent Psychiatric Inpatient Unit APIU
In Year 1 the investigators will further develop and refine an intervention implementation guide including a formalized treatment manual training and supervision protocols and data collection processes They will then pilot test implementation of ICI with 20 adolescents divided across the study age range of 12-17 years 20 parents and 10 providers After refinement of ICI based on findings from the pilot the investigators will recruit assess and randomly assign 60 youth with suicidal ideation andor behavior who are eligible for admission to both the YCSU and APIU to the YCSU n30 or APIU n30
The central hypothesis is that ICI will be acceptable to families and show greater improvements in the investigators proposed mechanism of change family functioning compared with results of traditional inpatient treatment assessing outcomes at discharge 30-day and 3-month follow-up The investigators have the following three specific aims
Specific Aim 1 To develop refine and pilot test ICI including the ICI treatment manual training and supervision protocols for youth with suicidal ideation andor behavior and to evaluate whether the proposed research implementation procedures are feasible and acceptable to adolescents parents and providers
Specific Aim 2 To conduct a small randomized controlled trial to examine preliminary acceptability and effectiveness of the ICI intervention on the basis of primary outcomes consumer satisfaction family functioning and secondary outcomes suicidal ideation suicide attempts emergency department EDinpatient admission hopelessness and therapeutic alliance
Hypothesis 2a ICI will result in higher consumer satisfaction compared to traditional inpatient treatment
Hypothesis 2b ICI will result in greater improvements in family functioning at discharge 30-days and 3-month follow-up compared to improvements made after traditional inpatient treatment
Hypothesis 2c ICI will result in lower rates of suicidal ideation attempts EDinpatient admissions lower hopelessness scores and higher ratings of therapeutic alliance compared to traditional inpatient treatment
Specific Aim 3 To identify barriers to and facilitators of implementation and sustainability of ICI using qualitative interviews and surveys with families and clinical and organizational stakeholders
In Year 1 the investigators will further develop and refine an intervention implementation guide including a formalized treatment manual training and supervision protocols and data collection processes They will then pilot test implementation of ICI with 20 adolescents divided across the study age range of 12-17 years 20 parents and 10 providers After refinement of ICI based on findings from the pilot the investigators will recruit assess and randomly assign 60 youth with suicidal ideation andor behavior who are eligible for admission to both the YCSU and APIU to the YCSU n30 or APIU n30
The central hypothesis is that ICI will be acceptable to families and show greater improvements in the investigators proposed mechanism of change family functioning compared with results of traditional inpatient treatment assessing outcomes at discharge 30-day and 3-month follow-up The investigators have the following three specific aims
Specific Aim 1 To develop refine and pilot test ICI including the ICI treatment manual training and supervision protocols for youth with suicidal ideation andor behavior and to evaluate whether the proposed research implementation procedures are feasible and acceptable to adolescents parents and providers
Specific Aim 2 To conduct a small randomized controlled trial to examine preliminary acceptability and effectiveness of the ICI intervention on the basis of primary outcomes consumer satisfaction family functioning and secondary outcomes suicidal ideation suicide attempts emergency department EDinpatient admission hopelessness and therapeutic alliance
Hypothesis 2a ICI will result in higher consumer satisfaction compared to traditional inpatient treatment
Hypothesis 2b ICI will result in greater improvements in family functioning at discharge 30-days and 3-month follow-up compared to improvements made after traditional inpatient treatment
Hypothesis 2c ICI will result in lower rates of suicidal ideation attempts EDinpatient admissions lower hopelessness scores and higher ratings of therapeutic alliance compared to traditional inpatient treatment
Specific Aim 3 To identify barriers to and facilitators of implementation and sustainability of ICI using qualitative interviews and surveys with families and clinical and organizational stakeholders
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 |
|---|---|---|---|
| 5P50MH127476-02 | NIH | None | None |