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Clinical Trials/NCT03527459
NCT03527459
Completed
Not Applicable

Implementing an Interpersonal Theory of Suicide Treatment Approach to Improve Outcomes in Suicidal Youth

University of Texas Southwestern Medical Center1 site in 1 country123 target enrollmentNovember 14, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicidal Ideation
Sponsor
University of Texas Southwestern Medical Center
Enrollment
123
Locations
1
Primary Endpoint
Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012)
Status
Completed
Last Updated
6 years ago

Overview

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 Children's, 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.

Registry
clinicaltrials.gov
Start Date
November 14, 2017
End Date
June 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sunita Stewart

Professor

University of Texas Southwestern Medical Center

Eligibility Criteria

Inclusion Criteria

  • adolescents, ages 12 - 17
  • enrolled in the SPARC program at Children's Medical Center of Dallas
  • completed at least 5 SPARC group therapy sessions

Exclusion Criteria

  • adolescents who have previously received treatment in the control arm of the study

Outcomes

Primary Outcomes

Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012)

Time Frame: through program completion, an average of 6 weeks

change in perceived burdensomeness

Concise Health Risk Tracking Self Report (CHRT-SR) (Trivedi et al., 2011)

Time Frame: through program completion, an average of 6 weeks

suicide ideation (self-report)

Secondary Outcomes

  • Concise Health Risk Tracking Self Report (CHRT-SR) (Trivedi et al., 2011)(1 month after program completion)
  • Quick Inventory of Depressive Symptomatology - Adolescent Version Self-Report (QIDS-A-SR-16) (Bernstein et al., 2010)(1 month after program completion)
  • Concise Health Risk Tracking Self Report (CHRT-SR)(between program completion, an average of 6 weeks, and 1 month after program completion)
  • Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012)(1 month after program completion)

Study Sites (1)

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