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Completed

NCT Number: NCT03527459

Implementing an IPTS Treatment Approach to Improve Outcomes in Suicidal Youth

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).

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Key information

Conditions

Suicidal Ideation Behavior Behavioral Symptoms Depression Self-Injurious Behavior Suicide

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Medical Center

Dallas, Texas, 75235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPARC B

Behavioral

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

SPARC A

Behavioral

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

Primary outcomes

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

    Time frame: 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)

    Time frame: through program completion, an average of 6 weeks

    suicide ideation (self-report)

Secondary outcomes

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

    Time frame: through program completion, an average of 6 weeks

    change in depressive symptoms

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

    Time frame: 1 month after program completion

    change in perceived burdensomeness

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

    Time frame: 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)

    Time frame: 1 month after program completion

    change in depressive symptoms

  5. Concise Health Risk Tracking Self Report (CHRT-SR)

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

    change in suicide ideation (self-report)

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 17, 2018
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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