Implementing an IPTS Treatment Approach to Improve Outcomes in Suicidal Youth

Not Applicable

Completed

• Conditions: Suicidal Ideation; Depression
• Interventions: Behavioral: SPARC A; Behavioral: SPARC B

• Registration Number: NCT03527459
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study Start: 2017-11-14
• Study First Submitted: 2018-05-02
• Study First Submitted QC: 2018-05-15
• Study First Posted: 2018-05-17
• Primary Completion: 2019-03-07
• Study Completion: 2019-06-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPARC A	SPARC A	SPARC A is an existing clinical program which has a general focus on negative cognitions.
SPARC B	SPARC B	SPARC B includes all aspects of the SPARC A clinical program, but targets negative cognitions of perceived burdensomeness in some sessions.

Primary Outcome Measures

Name	Time	Method
Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012)	through program completion, an average of 6 weeks	change in perceived burdensomeness
Concise Health Risk Tracking Self Report (CHRT-SR) (Trivedi et al., 2011)	through program completion, an average of 6 weeks	suicide ideation (self-report)

Secondary Outcome Measures

Name	Time	Method
Quick Inventory of Depressive Symptomatology - Adolescent Version Self-Report (QIDS-A-SR-16) (Bernstein et al., 2010)	1 month after program completion	change in depressive symptoms
Concise Health Risk Tracking Self Report (CHRT-SR) (Trivedi et al., 2011)	1 month after program completion	change in suicide ideation (self-report)
Concise Health Risk Tracking Self Report (CHRT-SR)	between program completion, an average of 6 weeks, and 1 month after program completion	change in suicide ideation (self-report)
Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012)	1 month after program completion	change in perceived burdensomeness

Trial Locations

Locations (1)

Children's Medical Center; 🇺🇸 Dallas, Texas, United States