Implementing an IPTS Treatment Approach to Improve Outcomes in Suicidal Youth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-14

Study Completion Date

2019-06-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Suicidal Ideation Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

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SPARC A

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

Group Type ACTIVE_COMPARATOR

SPARC A

Intervention Type BEHAVIORAL

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

SPARC B

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

Group Type EXPERIMENTAL

SPARC B

Intervention Type BEHAVIORAL

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

Interventions

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SPARC B

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

Intervention Type BEHAVIORAL

SPARC A

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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