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Bending Adolescent Depression Trajectories Through Personalized Prevention

2 marzo 2021 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

205

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Colorado
      • Denver, Colorado, Stati Uniti, 80208
        • University of Denver
    • Illinois
      • Champaign, Illinois, Stati Uniti, 61820
        • University of Illinois Urbana Champaign
    • New Jersey
      • Piscataway, New Jersey, Stati Uniti, 08854
        • Rutgers University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19146
        • Children's Hospital of Philadelphia

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 12 anni a 17 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Interpersonal Psychotherapy- Adolescent Skills Training
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.
Altri nomi:
  • IPT-AST
  • Teen Talk
Sperimentale: Coping with Stress
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.
Altri nomi:
  • CWS

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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)
Lasso di tempo: Post intervention (approximately 3 months post baseline)
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
Post intervention (approximately 3 months post baseline)
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)
Lasso di tempo: 6-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
6-months post-intervention
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)
Lasso di tempo: 12-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
12-months post-intervention
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)
Lasso di tempo: 18-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
18-months post-intervention
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)
Lasso di tempo: 24-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
24-months post-intervention
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)
Lasso di tempo: 30-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
30-months post-intervention
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)
Lasso di tempo: 36-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
36-months post-intervention
Children's Depression Inventory (CDI)
Lasso di tempo: Post intervention (approximately 3 months after baseline)
Self-reported depression scores
Post intervention (approximately 3 months after baseline)
Children's Depression Inventory (CDI)
Lasso di tempo: 6-months post-intervention
Self-reported depression scores
6-months post-intervention
Children's Depression Inventory (CDI)
Lasso di tempo: 12-months post-intervention
Self-reported depression scores
12-months post-intervention
Children's Depression Inventory (CDI)
Lasso di tempo: 18-months post-intervention
Self-reported depression scores
18-months post-intervention
Children's Depression Inventory (CDI)
Lasso di tempo: 24-months post-intervention
Self-reported depression scores
24-months post-intervention
Children's Depression Inventory (CDI)
Lasso di tempo: 30-months post-intervention
Self-reported depression scores
30-months post-intervention
Children's Depression Inventory (CDI)
Lasso di tempo: 36-months post-intervention
Self-reported depression scores
36-months post-intervention

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Children's Global Assessment Scale (CGAS)
Lasso di tempo: Post Intervention (approximately 3 months following baseline)
Assesses global functioning
Post Intervention (approximately 3 months following baseline)
Children's Global Assessment Scale (CGAS)
Lasso di tempo: 6-months followup
Assesses global functioning
6-months followup
Children's Global Assessment Scale (CGAS)
Lasso di tempo: 12-months followup
Assesses global functioning
12-months followup
Children's Global Assessment Scale (CGAS)
Lasso di tempo: 18-months followup
Assesses global functioning
18-months followup
Children's Global Assessment Scale (CGAS)
Lasso di tempo: 24-months followup
Assesses global functioning
24-months followup
Children's Global Assessment Scale (CGAS)
Lasso di tempo: 30-months followup
Assesses global functioning
30-months followup
Children's Global Assessment Scale (CGAS)
Lasso di tempo: 36-months followup
Assesses global functioning
36-months followup

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Jami F Young, Ph.D., Children's Hospital of Philadelphia

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2013

Completamento primario (Effettivo)

1 agosto 2019

Completamento dello studio (Effettivo)

1 agosto 2019

Date di iscrizione allo studio

Primo inviato

18 settembre 2013

Primo inviato che soddisfa i criteri di controllo qualità

18 settembre 2013

Primo Inserito (Stima)

23 settembre 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 marzo 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 marzo 2021

Ultimo verificato

1 marzo 2021

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 17-013831
  • R01MH077178 (Sovvenzione/contratto NIH degli Stati Uniti)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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