Implementing an IPTS Treatment Approach to Improve Outcomes in Suicidal Youth

NCT03527459 | Completed

• 1 other identifier: GA2016-010
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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).

Conditions

Suicidal Ideation; Depression

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

• Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012)

  1 month after program completion

• Concise Health Risk Tracking Self Report (CHRT-SR) (Trivedi et al., 2011)

  1 month after program completion

• Quick Inventory of Depressive Symptomatology - Adolescent Version Self-Report (QIDS-A-SR-16) (Bernstein et al., 2010)

  1 month after program completion

• Concise Health Risk Tracking Self Report (CHRT-SR)

  between program completion, an average of 6 weeks, and 1 month after program completion

Study Arms (2)

SPARC A

ACTIVE COMPARATOR

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

Behavioral: SPARC A

SPARC B

EXPERIMENTAL

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

Behavioral: SPARC B

Interventions

SPARC B BEHAVIORAL

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

SPARC B

SPARC A BEHAVIORAL

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

SPARC A

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• adolescents, ages 12 - 17
• enrolled in the SPARC program at Children's Medical Center of Dallas
• completed at least 5 SPARC group therapy sessions

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Children's Medical Center

Dallas, Texas, 75235, United States

Location

Related 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.

  PMID: 20683845 BACKGROUND

• 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.

  PMID: 21733476 BACKGROUND

• 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.

  PMID: 21928908 BACKGROUND

MeSH Terms

Conditions

Suicidal Ideation; Depression

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Sunita M. Stewart, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 17, 2018
• Study Start: November 14, 2017
• Primary Completion: March 7, 2019
• Study Completion: June 1, 2019
• Last Updated: November 1, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)