- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03781037
Targeting Burdensomeness Among Clinic Referred Youth
12. Mai 2021 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
18
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Florida
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Miami, Florida, Vereinigte Staaten, 33199
- Florida International University Center for Children and Families
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
10 Jahre bis 17 Jahre (Kind)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
6-item Youth Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
10-item Youth Rated Warmth Subscale of the Child Report of Parental Behavior Inventory
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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).
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post-intervention (within one week of completing the GIVE Module)
|
41-item Parent Rated Screen for Child Anxiety Related Emotional Disorders
Zeitfenster: 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
Zeitfenster: 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.
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post-intervention (within one week of completing the GIVE Module)
|
17-item Parent Rated Children's Depression Inventory - 2
Zeitfenster: 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.
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post-intervention (within one week of completing the GIVE Module)
|
8-item Youth Rated Client Satisfaction Questionnaire
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
20. März 2019
Primärer Abschluss (Tatsächlich)
30. Dezember 2020
Studienabschluss (Tatsächlich)
30. Dezember 2020
Studienanmeldedaten
Zuerst eingereicht
18. Dezember 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
18. Dezember 2018
Zuerst gepostet (Tatsächlich)
19. Dezember 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. Juni 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. Mai 2021
Zuletzt verifiziert
1. Mai 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 1F31MH116603 (US NIH Stipendium/Vertrag)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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