- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03527459
Implementing an IPTS Treatment Approach to Improve Outcomes in Suicidal Youth
30. oktober 2019 opdateret af: Sunita Stewart, University of Texas Southwestern Medical Center
Implementing an Interpersonal Theory of Suicide 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).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
123
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75235
- Children's Medical Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
12 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: SPARC A
SPARC A is an existing clinical program which has a general focus on negative cognitions.
|
SPARC A is an existing clinical program with a general focus on negative cognitions.
|
Eksperimentel: SPARC B
SPARC B includes all aspects of the SPARC A clinical program, but targets negative cognitions of perceived burdensomeness in some sessions.
|
SPARC B includes all aspects of the SPARC A clinical program, as well as targeting negative cognitions of perceived burdensomeness.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012)
Tidsramme: through program completion, an average of 6 weeks
|
change in perceived burdensomeness
|
through program completion, an average of 6 weeks
|
Concise Health Risk Tracking Self Report (CHRT-SR) (Trivedi et al., 2011)
Tidsramme: through program completion, an average of 6 weeks
|
suicide ideation (self-report)
|
through program completion, an average of 6 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Quick Inventory of Depressive Symptomatology - Adolescent Version Self-Report (QIDS-A-SR-16) (Bernstein et al., 2010)
Tidsramme: through program completion, an average of 6 weeks
|
change in depressive symptoms
|
through program completion, an average of 6 weeks
|
Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012)
Tidsramme: 1 month after program completion
|
change in perceived burdensomeness
|
1 month after program completion
|
Concise Health Risk Tracking Self Report (CHRT-SR) (Trivedi et al., 2011)
Tidsramme: 1 month after program completion
|
change in suicide ideation (self-report)
|
1 month after program completion
|
Quick Inventory of Depressive Symptomatology - Adolescent Version Self-Report (QIDS-A-SR-16) (Bernstein et al., 2010)
Tidsramme: 1 month after program completion
|
change in depressive symptoms
|
1 month after program completion
|
Concise Health Risk Tracking Self Report (CHRT-SR)
Tidsramme: between program completion, an average of 6 weeks, and 1 month after program completion
|
change in suicide ideation (self-report)
|
between program completion, an average of 6 weeks, and 1 month after program completion
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Sunita M. Stewart, PhD, UT Southwestern Medical Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. november 2017
Primær færdiggørelse (Faktiske)
7. marts 2019
Studieafslutning (Faktiske)
1. juni 2019
Datoer for studieregistrering
Først indsendt
2. maj 2018
Først indsendt, der opfyldte QC-kriterier
15. maj 2018
Først opslået (Faktiske)
17. maj 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. november 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. oktober 2019
Sidst verificeret
1. oktober 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GA2016-010
Plan for individuelle deltagerdata (IPD)
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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