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Bending Adolescent Depression Trajectories Through Personalized Prevention

2 mars 2021 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

205

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

12 ans à 17 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autres noms:
  • IPT-AST
  • Teen Talk
Expérimental: 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.
Autres noms:
  • CWS

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: Post intervention (approximately 3 months after baseline)
Self-reported depression scores
Post intervention (approximately 3 months after baseline)
Children's Depression Inventory (CDI)
Délai: 6-months post-intervention
Self-reported depression scores
6-months post-intervention
Children's Depression Inventory (CDI)
Délai: 12-months post-intervention
Self-reported depression scores
12-months post-intervention
Children's Depression Inventory (CDI)
Délai: 18-months post-intervention
Self-reported depression scores
18-months post-intervention
Children's Depression Inventory (CDI)
Délai: 24-months post-intervention
Self-reported depression scores
24-months post-intervention
Children's Depression Inventory (CDI)
Délai: 30-months post-intervention
Self-reported depression scores
30-months post-intervention
Children's Depression Inventory (CDI)
Délai: 36-months post-intervention
Self-reported depression scores
36-months post-intervention

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Children's Global Assessment Scale (CGAS)
Délai: Post Intervention (approximately 3 months following baseline)
Assesses global functioning
Post Intervention (approximately 3 months following baseline)
Children's Global Assessment Scale (CGAS)
Délai: 6-months followup
Assesses global functioning
6-months followup
Children's Global Assessment Scale (CGAS)
Délai: 12-months followup
Assesses global functioning
12-months followup
Children's Global Assessment Scale (CGAS)
Délai: 18-months followup
Assesses global functioning
18-months followup
Children's Global Assessment Scale (CGAS)
Délai: 24-months followup
Assesses global functioning
24-months followup
Children's Global Assessment Scale (CGAS)
Délai: 30-months followup
Assesses global functioning
30-months followup
Children's Global Assessment Scale (CGAS)
Délai: 36-months followup
Assesses global functioning
36-months followup

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Jami F Young, Ph.D., Children's Hospital of Philadelphia

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2013

Achèvement primaire (Réel)

1 août 2019

Achèvement de l'étude (Réel)

1 août 2019

Dates d'inscription aux études

Première soumission

18 septembre 2013

Première soumission répondant aux critères de contrôle qualité

18 septembre 2013

Première publication (Estimation)

23 septembre 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 mars 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 mars 2021

Dernière vérification

1 mars 2021

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 17-013831
  • R01MH077178 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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