Implementing an IPTS Treatment Approach to Improve Outcomes in Suicidal Youth

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03527459
• Other study ID #: GA2016-010
• Status: Completed
• Phase: N/A
• Start date: November 14, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: October 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: June 1, 2019
• Est. primary completion date: March 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Suicidal Ideation

Intervention

Behavioral:
• SPARC B
SPARC B includes all aspects of the SPARC A clinical program, as well as targeting negative cognitions of perceived burdensomeness.
• SPARC A
SPARC A is an existing clinical program with a general focus on negative cognitions.

Locations

Country	Name	City	State
United States	Children's Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bernstein IH, Rush AJ, Trivedi MH, Hughes CW, Macleod L, Witte BP, Jain S, Mayes TL, Emslie GJ. Psychometric properties of the Quick Inventory of Depressive Symptomatology in adolescents. Int J Methods Psychiatr Res. 2010 Dec;19(4):185-94. doi: 10.1002/mpr.321. — View Citation

Trivedi MH, Wisniewski SR, Morris DW, Fava M, Gollan JK, Warden D, Nierenberg AA, Gaynes BN, Husain MM, Luther JF, Zisook S, Rush AJ. Concise Health Risk Tracking scale: a brief self-report and clinician rating of suicidal risk. J Clin Psychiatry. 2011 Jun;72(6):757-64. doi: 10.4088/JCP.11m06837. — View Citation

Van Orden KA, Cukrowicz KC, Witte TK, Joiner TE. Thwarted belongingness and perceived burdensomeness: construct validity and psychometric properties of the Interpersonal Needs Questionnaire. Psychol Assess. 2012 Mar;24(1):197-215. doi: 10.1037/a0025358. Epub 2011 Sep 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012)	change in perceived burdensomeness	through program completion, an average of 6 weeks
Primary	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	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
Secondary	Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012)	change in perceived burdensomeness	1 month after program completion
Secondary	Concise Health Risk Tracking Self Report (CHRT-SR) (Trivedi et al., 2011)	change in suicide ideation (self-report)	1 month after program completion
Secondary	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
Secondary	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