Implementing an IPTS Treatment Approach to Improve Outcomes in Suicidal Youth

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Suicidal Ideation, Depression

Intervention / Treatment
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* Behavioral: SPARC B
* Behavioral: SPARC A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Half of the clients in the SPARC clinical program are enrolled into either the original program 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. We will assess relative impact of SPARC A and SPARC B on depressive symptoms and suicide ideation. Our investigation will allow us to assess whether this innovation 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SPARC A<br>SPARC A is an existing clinical program which has a general focus on negative cognitions. | Behavioral: SPARC A<br>* SPARC A is an existing clinical program with a general focus on negative cognitions.<br>|
| Experimental: SPARC B<br>SPARC B includes all aspects of the SPARC A clinical program, but targets negative cognitions of perceived burdensomeness in some sessions. | Behavioral: SPARC B<br>* SPARC B includes all aspects of the SPARC A clinical program, as well as targeting negative cognitions of perceived burdensomeness.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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