Implementing an IPTS Treatment Approach to Improve Outcomes in Suicidal Youth
Primary Purpose
Suicidal Ideation, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SPARC B
SPARC A
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Ideation
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
Sites / Locations
- Children's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
SPARC A
SPARC B
Arm Description
SPARC A is an existing clinical program which has a general focus on negative cognitions.
SPARC B includes all aspects of the SPARC A clinical program, but targets negative cognitions of perceived burdensomeness in some sessions.
Outcomes
Primary Outcome Measures
Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012)
change in perceived burdensomeness
Concise Health Risk Tracking Self Report (CHRT-SR) (Trivedi et al., 2011)
suicide ideation (self-report)
Secondary Outcome Measures
Quick Inventory of Depressive Symptomatology - Adolescent Version Self-Report (QIDS-A-SR-16) (Bernstein et al., 2010)
change in depressive symptoms
Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012)
change in perceived burdensomeness
Concise Health Risk Tracking Self Report (CHRT-SR) (Trivedi et al., 2011)
change in suicide ideation (self-report)
Quick Inventory of Depressive Symptomatology - Adolescent Version Self-Report (QIDS-A-SR-16) (Bernstein et al., 2010)
change in depressive symptoms
Concise Health Risk Tracking Self Report (CHRT-SR)
change in suicide ideation (self-report)
Full Information
NCT ID
NCT03527459
First Posted
May 2, 2018
Last Updated
October 30, 2019
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03527459
Brief Title
Implementing an IPTS Treatment Approach to Improve Outcomes in Suicidal Youth
Official Title
Implementing an Interpersonal Theory of Suicide Treatment Approach to Improve Outcomes in Suicidal Youth
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 14, 2017 (Actual)
Primary Completion Date
March 7, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare Provider
Masking Description
Participants are masked as to the treatment arm to which they are assigned. Care providers in the control arm are masked to the interventions being tested in the experimental arm, so as to not inadvertently deliver aspects of SPARC B intervention to the SPARC A group. The outcomes assessor is not collecting primary outcome data, which is self-reported via online survey.
Allocation
Non-Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPARC A
Arm Type
Active Comparator
Arm Description
SPARC A is an existing clinical program which has a general focus on negative cognitions.
Arm Title
SPARC B
Arm Type
Experimental
Arm Description
SPARC B includes all aspects of the SPARC A clinical program, but targets negative cognitions of perceived burdensomeness in some sessions.
Intervention Type
Behavioral
Intervention Name(s)
SPARC B
Intervention Description
SPARC B includes all aspects of the SPARC A clinical program, as well as targeting negative cognitions of perceived burdensomeness.
Intervention Type
Behavioral
Intervention Name(s)
SPARC A
Intervention Description
SPARC A is an existing clinical program with a general focus on negative cognitions.
Primary Outcome Measure Information:
Title
Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012)
Description
change in perceived burdensomeness
Time Frame
through program completion, an average of 6 weeks
Title
Concise Health Risk Tracking Self Report (CHRT-SR) (Trivedi et al., 2011)
Description
suicide ideation (self-report)
Time Frame
through program completion, an average of 6 weeks
Secondary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptomatology - Adolescent Version Self-Report (QIDS-A-SR-16) (Bernstein et al., 2010)
Description
change in depressive symptoms
Time Frame
through program completion, an average of 6 weeks
Title
Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012)
Description
change in perceived burdensomeness
Time Frame
1 month after program completion
Title
Concise Health Risk Tracking Self Report (CHRT-SR) (Trivedi et al., 2011)
Description
change in suicide ideation (self-report)
Time Frame
1 month after program completion
Title
Quick Inventory of Depressive Symptomatology - Adolescent Version Self-Report (QIDS-A-SR-16) (Bernstein et al., 2010)
Description
change in depressive symptoms
Time Frame
1 month after program completion
Title
Concise Health Risk Tracking Self Report (CHRT-SR)
Description
change in suicide ideation (self-report)
Time Frame
between program completion, an average of 6 weeks, and 1 month after program completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunita M. Stewart, PhD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20683845
Citation
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.
Results Reference
background
PubMed Identifier
21733476
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.
Results Reference
background
PubMed Identifier
21928908
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.
Results Reference
background
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Implementing an IPTS Treatment Approach to Improve Outcomes in Suicidal Youth
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