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Targeting Burdensomeness Among Clinic Referred Youth

12. maj 2021 opdateret af: Florida International University
This study will develop and pilot test a novel intervention module targeting perceived burdensomeness toward others in 30 clinic referred youths who experience anxiety or depression and elevated levels of burdensomeness. All participants will be assigned to receive the intervention in this open trial.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

Suicidal ideation is prevalent and impairing in youth, with approximately 15% of high school students reporting seriously considering a suicide attempt and making a specific plan for suicide in the past 12 months. Substantial evidence documents perceived burdensomeness towards others, or the belief that one is a burden or drain on others, as a risk factor for suicide ideation in youth. This evidence highlights the potential promise of perceived burdensomeness as a novel intervention target to prevent suicide ideation in youth. The current study will develop and preliminary evaluate a novel, brief behavioral treatment module targeting perceived burdensomeness in youth that can be embedded within existing psychosocial treatments. The study will use an open trial design. The first aim of this proposal is to develop a novel, brief psychosocial intervention module (the GIVE module) targeting perceived burdensomeness towards others that can be embedded within existing CBT protocols for youth internalizing problems. The second aim is to collect data relevant to client satisfaction and reductions in perceived burdensomeness. Participants will be N=30 clinic-referred youth ages 10 to 17 years with anxiety or depressive disorders in a university-based research clinic, who display elevated levels of perceived burdensomeness. In the context on ongoing CBT for anxiety or depression, participants will complete the GIVE module at sessions 6 and 7 of the CBT protocol. It is hypothesized that perceived burdensomeness will be significantly lower after the GIVE module is administered, and that client satisfaction will be high. Data collected in this study will provide the foundation for a subsequent randomized controlled trial of the GIVE module.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

18

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Florida
      • Miami, Florida, Forenede Stater, 33199
        • Florida International University Center for Children and Families

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

10 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Clinical diagnosis of an anxiety disorder, persistent depressive disorder, or major depressive disorder
  • Score > 4 on the youth self-report Interpersonal Needs Questionnaire- Perceived Burdensomeness Scale

Exclusion Criteria:

  • Clinical diagnosis of a Psychotic Disorder, Autism Spectrum Disorder or Intellectual Disability
  • Show high risk of imminent self-injurious behaviors
  • Be involved currently in another behavioral treatment
  • Not live with a primary caregiver who is legally able to give consent for the youth's participation
  • Be a victim of previously undisclosed abuse requiring investigation or ongoing supervision by the Department of Children and Families.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: GIVE module
The GIVE module consists of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression. The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.
The GIVE Module is a brief cognitive behavioral intervention targeting youths' beliefs that they are a burden or drain on others. It consists of two sessions embedded within a larger CBT protocol for anxiety or depression.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
6-item Youth Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire
Tidsramme: post-intervention (within one week of completing the GIVE Module)
Youth self-ratings on perceived burdensomeness over the past week. Each item is scored 1-7 (1 = not at all true for me; 7 = very true for me), yielding a total between 6 and 42. Higher scores indicate higher levels of perceived burdensomeness (worse outcome).
post-intervention (within one week of completing the GIVE Module)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
10-item Youth Rated Warmth Subscale of the Child Report of Parental Behavior Inventory
Tidsramme: post-intervention (within one week of completing the GIVE Module)
Youth ratings on parental warmth over the past week. Each of 10 items is scored 1-3 (1 = not like parent; 3 = a lot like parent), yielding a total score of 10 to 30. Higher scores indicate higher levels of parental warmth (better outcome).
post-intervention (within one week of completing the GIVE Module)
10-item Parent Rated Warmth Subscale of the Parent Report of Parental Behavior Inventory
Tidsramme: post-intervention (within one week of completing the GIVE Module)
Parent self-ratings on parental warmth over the past week. Each of 10 items is scored 1-3 (1 = not like me; 3 = a lot like me), yielding a total score of 10 to 30. Higher scores indicate higher levels of parental warmth (better outcome).
post-intervention (within one week of completing the GIVE Module)
41-item Youth Rated Screen for Child Anxiety Related Emotional Disorders
Tidsramme: post-intervention (within one week of completing the GIVE Module)
Youth self-ratings on anxiety symptom severity. Each item is scored 0-2 (0 = not true; 2 = very true), yielding a total score of 0 to 82. Higher scores indicate higher levels of anxiety (worse outcome).
post-intervention (within one week of completing the GIVE Module)
41-item Parent Rated Screen for Child Anxiety Related Emotional Disorders
Tidsramme: post-intervention (within one week of completing the GIVE Module)
Parent ratings on youth anxiety symptom severity. Each item is scored 0-2 (0 = not true; 2 = very true), yielding a total score of 0 to 82. Higher scores indicate higher levels of anxiety (worse outcome).
post-intervention (within one week of completing the GIVE Module)
28-item Youth-rated Children's Depression Inventory - 2
Tidsramme: post-intervention (within one week of completing the GIVE Module)
Youth self-ratings on depressive symptom severity. Each item is scored 0-2, yielding total scores of 0 to 56, with higher scores corresponding to more severe symptoms.
post-intervention (within one week of completing the GIVE Module)
17-item Parent Rated Children's Depression Inventory - 2
Tidsramme: post-intervention (within one week of completing the GIVE Module)
Parent ratings on youth depressive symptom severity. Each item is scored 0-3, yielding total scores of 0 to 51, with higher scores corresponding to more severe symptoms.
post-intervention (within one week of completing the GIVE Module)
8-item Youth Rated Client Satisfaction Questionnaire
Tidsramme: post-intervention (within one week of completing the GIVE Module)
Youth ratings of satisfaction with the GIVE module. Each item is score 1-4 (1 = quite dissatisfied; 4 = very satisfied), yielding total scores of 8-32. Higher scores indicate higher satisfaction (better outcome).
post-intervention (within one week of completing the GIVE Module)
8-item Parent Rated Client Satisfaction Questionnaire
Tidsramme: post-intervention (within one week of completing the GIVE Module)
Parent ratings of satisfaction with the GIVE module. Each item is score 1-4 (1 = quite dissatisfied; 4 = very satisfied), yielding total scores of 8-32.
post-intervention (within one week of completing the GIVE Module)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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)

20. marts 2019

Primær færdiggørelse (Faktiske)

30. december 2020

Studieafslutning (Faktiske)

30. december 2020

Datoer for studieregistrering

Først indsendt

18. december 2018

Først indsendt, der opfyldte QC-kriterier

18. december 2018

Først opslået (Faktiske)

19. december 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2021

Sidst verificeret

1. maj 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 1F31MH116603 (U.S. NIH-bevilling/kontrakt)

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