- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01948167
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
Stato
Completato
Condizioni
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
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Colorado
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Denver, Colorado, Stati Uniti, 80208
- University of Denver
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Illinois
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Champaign, Illinois, Stati Uniti, 61820
- University of Illinois Urbana Champaign
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New Jersey
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Piscataway, New Jersey, Stati Uniti, 08854
- Rutgers University
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19146
- Children's Hospital of Philadelphia
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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 |
|---|---|
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Sperimentale: 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.
Altri nomi:
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Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 12-months post-intervention
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Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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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
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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)
Lasso di tempo: 24-months post-intervention
|
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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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)
Lasso di tempo: 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)
Lasso di tempo: 36-months post-intervention
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Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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36-months post-intervention
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Children's Depression Inventory (CDI)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 12-months post-intervention
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Self-reported depression scores
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12-months post-intervention
|
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Children's Depression Inventory (CDI)
Lasso di tempo: 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)
Lasso di tempo: 24-months post-intervention
|
Self-reported depression scores
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24-months post-intervention
|
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Children's Depression Inventory (CDI)
Lasso di tempo: 30-months post-intervention
|
Self-reported depression scores
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30-months post-intervention
|
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Children's Depression Inventory (CDI)
Lasso di tempo: 36-months post-intervention
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Self-reported depression scores
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36-months post-intervention
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Children's Global Assessment Scale (CGAS)
Lasso di tempo: 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)
Lasso di tempo: 6-months followup
|
Assesses global functioning
|
6-months followup
|
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Children's Global Assessment Scale (CGAS)
Lasso di tempo: 12-months followup
|
Assesses global functioning
|
12-months followup
|
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Children's Global Assessment Scale (CGAS)
Lasso di tempo: 18-months followup
|
Assesses global functioning
|
18-months followup
|
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Children's Global Assessment Scale (CGAS)
Lasso di tempo: 24-months followup
|
Assesses global functioning
|
24-months followup
|
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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.
Collaboratori
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
Parole chiave
Termini MeSH pertinenti aggiuntivi
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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