Viewing Study NCT03527459



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Last Modification Date: 2024-10-26 @ 12:45 PM
Study NCT ID: NCT03527459
Status: COMPLETED
Last Update Posted: 2019-11-01
First Post: 2018-05-02

Brief Title: Implementing an IPTS Treatment Approach to Improve Outcomes in Suicidal Youth
Sponsor: University of Texas Southwestern Medical Center
Organization: University of Texas Southwestern Medical Center

Study Overview

Official Title: Implementing an Interpersonal Theory of Suicide Treatment Approach to Improve Outcomes in Suicidal Youth
Status: COMPLETED
Status Verified Date: 2019-10
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: The purpose of this project is to evaluate a set of interventions derived from a theory of suicide that supplements a clinical program and compare their effects on outcomes to the outcomes of the unsupplemented program This study proposes to evaluate the effect of these interventions on reducing specific negative cognitions associated with depression and suicide ideation in an intensive outpatient program for suicidal youth Suicide Prevention and Resilience at Childrens SPARC
Detailed Description: The trial will be conducted in a program where half of the clients are enrolled into either the original program SPARC A which has a general focus on negative cognitions or SPARC B which will overlap significantly with SPARC A but targets in some sessions specific negative cognitions of perceived burdensomeness The program is already structured so that each patient consistently attends either a morning or an afternoon track with different therapists running each track This allows for separate programs in each track Clinically justifiable innovations are routinely introduced into the program usually in a stepwise fashion in one or another part by one set of therapists at a time The investigators propose to take advantage of this partial introduction by assessing relative impact of SPARC A and SPARC B on depressive symptoms and suicide ideation The investigators have no data to indicate that one program will be better than the other The investigation will however allow the investigators to assess whether this innovation in fact is effective Patients will not be randomized at the individual level but rather their time slot usually decided based on opening within the program will place them into either SPARC A or SPARC B The two programs are of identical length with numerous features in common differing only in the specificity of the exercises and examples and their relevance to perceived burdensomeness Routine assessments at entry and discharge from the program will not change based on study enrollment However suicide ideation depressive symptoms and negative cognitions perceived burdensomeness and thwarted belongingness will be more formally assessed at the one-month follow-up meeting or phone call which will add approximately 10 minutes to the contact

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