Implementing an IPTS Treatment Approach to Improve Outcomes in Suicidal Youth

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03527459
Collaborator
(none)
123
1
2
18.5
6.6

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: SPARC B
  • Behavioral: SPARC A
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
123 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Participant, Care 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.
Primary Purpose:
Treatment
Official Title:
Implementing an Interpersonal Theory of Suicide Treatment Approach to Improve Outcomes in Suicidal Youth
Actual Study Start Date :
Nov 14, 2017
Actual Primary Completion Date :
Mar 7, 2019
Actual Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: SPARC A

SPARC A is an existing clinical program which has a general focus on negative cognitions.

Behavioral: SPARC A
SPARC A is an existing clinical program with a general focus on negative cognitions.

Experimental: SPARC B

SPARC B includes all aspects of the SPARC A clinical program, but targets negative cognitions of perceived burdensomeness in some sessions.

Behavioral: SPARC B
SPARC B includes all aspects of the SPARC A clinical program, as well as targeting negative cognitions of perceived burdensomeness.

Outcome Measures

Primary Outcome Measures

  1. Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012) [through program completion, an average of 6 weeks]

    change in perceived burdensomeness

  2. 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

  1. Quick Inventory of Depressive Symptomatology - Adolescent Version Self-Report (QIDS-A-SR-16) (Bernstein et al., 2010) [through program completion, an average of 6 weeks]

    change in depressive symptoms

  2. Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012) [1 month after program completion]

    change in perceived burdensomeness

  3. Concise Health Risk Tracking Self Report (CHRT-SR) (Trivedi et al., 2011) [1 month after program completion]

    change in suicide ideation (self-report)

  4. 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

  5. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Medical Center Dallas Texas United States 75235

Sponsors and Collaborators

  • University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Sunita M. Stewart, PhD, UT Southwestern Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sunita Stewart, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT03527459
Other Study ID Numbers:
  • GA2016-010
First Posted:
May 17, 2018
Last Update Posted:
Nov 1, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 1, 2019