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Bending Adolescent Depression Trajectories Through Personalized Prevention

2 maart 2021 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

205

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

12 jaar tot 17 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Andere namen:
  • IPT-AST
  • Teen Talk
Experimenteel: 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.
Andere namen:
  • CWS

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: Post intervention (approximately 3 months after baseline)
Self-reported depression scores
Post intervention (approximately 3 months after baseline)
Children's Depression Inventory (CDI)
Tijdsspanne: 6-months post-intervention
Self-reported depression scores
6-months post-intervention
Children's Depression Inventory (CDI)
Tijdsspanne: 12-months post-intervention
Self-reported depression scores
12-months post-intervention
Children's Depression Inventory (CDI)
Tijdsspanne: 18-months post-intervention
Self-reported depression scores
18-months post-intervention
Children's Depression Inventory (CDI)
Tijdsspanne: 24-months post-intervention
Self-reported depression scores
24-months post-intervention
Children's Depression Inventory (CDI)
Tijdsspanne: 30-months post-intervention
Self-reported depression scores
30-months post-intervention
Children's Depression Inventory (CDI)
Tijdsspanne: 36-months post-intervention
Self-reported depression scores
36-months post-intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Children's Global Assessment Scale (CGAS)
Tijdsspanne: Post Intervention (approximately 3 months following baseline)
Assesses global functioning
Post Intervention (approximately 3 months following baseline)
Children's Global Assessment Scale (CGAS)
Tijdsspanne: 6-months followup
Assesses global functioning
6-months followup
Children's Global Assessment Scale (CGAS)
Tijdsspanne: 12-months followup
Assesses global functioning
12-months followup
Children's Global Assessment Scale (CGAS)
Tijdsspanne: 18-months followup
Assesses global functioning
18-months followup
Children's Global Assessment Scale (CGAS)
Tijdsspanne: 24-months followup
Assesses global functioning
24-months followup
Children's Global Assessment Scale (CGAS)
Tijdsspanne: 30-months followup
Assesses global functioning
30-months followup
Children's Global Assessment Scale (CGAS)
Tijdsspanne: 36-months followup
Assesses global functioning
36-months followup

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2013

Primaire voltooiing (Werkelijk)

1 augustus 2019

Studie voltooiing (Werkelijk)

1 augustus 2019

Studieregistratiedata

Eerst ingediend

18 september 2013

Eerst ingediend dat voldeed aan de QC-criteria

18 september 2013

Eerst geplaatst (Schatting)

23 september 2013

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 maart 2021

Laatste update ingediend die voldeed aan QC-criteria

2 maart 2021

Laatst geverifieerd

1 maart 2021

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 17-013831
  • R01MH077178 (Subsidie/contract van de Amerikaanse NIH)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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