- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01948167
Bending Adolescent Depression Trajectories Through Personalized Prevention
2. März 2021 aktualisiert von: Children's Hospital of Philadelphia
Investigators will combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Investigators will innovatively combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence.
A randomized controlled trial will examine the benefits of matching youth to two depression prevention programs of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) and Coping with Stress (CWS) for the prevention of depression in adolescents.
These two programs are designed to address distinct risk factors for depression - CWS addresses cognitive risks and IPT-AST addresses interpersonal risks.
A total of 210 participants across two sites, University of Denver and Rutgers University, will be stratified on cognitive and interpersonal risk and randomized to the two conditions.
The goals of the study are to (1) demonstrate that prevention programs can modify depression trajectories among youth by examining within person changes in trajectories over time (three years before and three years after the prevention programs) and by comparing trajectories of prevention youth with changes in same aged cohorts; (2) evaluate a personalized prevention approach to bending depression trajectories by matching and mismatching youth to either CWS or IPT-AST based on individual risk profiles; (3) examine mechanisms of bending depression trajectories and test whether the prevention programs operate via their hypothesized processes; and (4) explore how genetic susceptibility, emotion regulation, and temperament may affect individual response to IPT-AST and CWS.
By implementing evidence-based prevention programs after 3-years of prospective naturalistic data collection, this study will contribute essential data on personalized medicine and altering developmental trajectories of first-onset depression.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
205
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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Colorado
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Denver, Colorado, Vereinigte Staaten, 80208
- University of Denver
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Illinois
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Champaign, Illinois, Vereinigte Staaten, 61820
- University of Illinois Urbana Champaign
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New Jersey
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Piscataway, New Jersey, Vereinigte Staaten, 08854
- Rutgers University
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19146
- Children's Hospital of Philadelphia
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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
12 Jahre bis 17 Jahre (Kind)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Currently in the 6th to 11th grades
- Adolescent and parent must be English-speaking
- Parental consent and adolescent consent
Exclusion Criteria:
- Presence of current Major Depressive Disorder, dysthymia, bipolar disorder, or significant psychosis
- Suicide attempt in the past week or significant suicidal ideation in the past week
- Presence of significant psychopathology or significant pervasive developmental delays that would make the group inappropriate
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Interpersonal Psychotherapy- Adolescent Skills Training
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A group prevention program that includes a 60-minute pre-group session, 8 weekly 90-minute group sessions, a 60-minute mid-group session, and 3 60-minute booster sessions.
IPT-AST focuses on psychoeducation and interpersonal skill-building to decrease interpersonal conflict and increase interpersonal support and competence.
Andere Namen:
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Experimental: Coping with Stress
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A group prevention program that consists of 8 acute 90-minute group sessions, 2 parent group sessions, and 3 continuation sessions lasting 60 minutes each.
Participants are taught to apply cognitive techniques to their personal thoughts, with the goal of generating effective counterarguments to unrealistic negative beliefs.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Presence of a Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Zeitfenster: Post intervention (approximately 3 months post baseline)
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Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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Post intervention (approximately 3 months post baseline)
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Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Zeitfenster: 6-months post-intervention
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Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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6-months post-intervention
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Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Zeitfenster: 12-months post-intervention
|
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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12-months post-intervention
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Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Zeitfenster: 18-months post-intervention
|
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
|
18-months post-intervention
|
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Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Zeitfenster: 24-months post-intervention
|
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
|
24-months post-intervention
|
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Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Zeitfenster: 30-months post-intervention
|
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
|
30-months post-intervention
|
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Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Zeitfenster: 36-months post-intervention
|
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
|
36-months post-intervention
|
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Children's Depression Inventory (CDI)
Zeitfenster: Post intervention (approximately 3 months after baseline)
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Self-reported depression scores
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Post intervention (approximately 3 months after baseline)
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Children's Depression Inventory (CDI)
Zeitfenster: 6-months post-intervention
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Self-reported depression scores
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6-months post-intervention
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Children's Depression Inventory (CDI)
Zeitfenster: 12-months post-intervention
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Self-reported depression scores
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12-months post-intervention
|
|
Children's Depression Inventory (CDI)
Zeitfenster: 18-months post-intervention
|
Self-reported depression scores
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18-months post-intervention
|
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Children's Depression Inventory (CDI)
Zeitfenster: 24-months post-intervention
|
Self-reported depression scores
|
24-months post-intervention
|
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Children's Depression Inventory (CDI)
Zeitfenster: 30-months post-intervention
|
Self-reported depression scores
|
30-months post-intervention
|
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Children's Depression Inventory (CDI)
Zeitfenster: 36-months post-intervention
|
Self-reported depression scores
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36-months post-intervention
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Children's Global Assessment Scale (CGAS)
Zeitfenster: Post Intervention (approximately 3 months following baseline)
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Assesses global functioning
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Post Intervention (approximately 3 months following baseline)
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Children's Global Assessment Scale (CGAS)
Zeitfenster: 6-months followup
|
Assesses global functioning
|
6-months followup
|
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Children's Global Assessment Scale (CGAS)
Zeitfenster: 12-months followup
|
Assesses global functioning
|
12-months followup
|
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Children's Global Assessment Scale (CGAS)
Zeitfenster: 18-months followup
|
Assesses global functioning
|
18-months followup
|
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Children's Global Assessment Scale (CGAS)
Zeitfenster: 24-months followup
|
Assesses global functioning
|
24-months followup
|
|
Children's Global Assessment Scale (CGAS)
Zeitfenster: 30-months followup
|
Assesses global functioning
|
30-months followup
|
|
Children's Global Assessment Scale (CGAS)
Zeitfenster: 36-months followup
|
Assesses global functioning
|
36-months followup
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Jami F Young, Ph.D., Children's Hospital of Philadelphia
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
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
1. September 2013
Primärer Abschluss (Tatsächlich)
1. August 2019
Studienabschluss (Tatsächlich)
1. August 2019
Studienanmeldedaten
Zuerst eingereicht
18. September 2013
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
18. September 2013
Zuerst gepostet (Schätzen)
23. September 2013
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
4. März 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
2. März 2021
Zuletzt verifiziert
1. März 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 17-013831
- R01MH077178 (US NIH Stipendium/Vertrag)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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