- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01948167
Bending Adolescent Depression Trajectories Through Personalized Prevention
2. marts 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
205
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Colorado
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Denver, Colorado, Forenede Stater, 80208
- University of Denver
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Illinois
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Champaign, Illinois, Forenede Stater, 61820
- University of Illinois Urbana Champaign
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New Jersey
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Piscataway, New Jersey, Forenede Stater, 08854
- Rutgers University
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19146
- Children's Hospital of Philadelphia
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
12 år til 17 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
Andre navne:
|
Eksperimentel: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 6-months post-intervention
|
Self-reported depression scores
|
6-months post-intervention
|
Children's Depression Inventory (CDI)
Tidsramme: 12-months post-intervention
|
Self-reported depression scores
|
12-months post-intervention
|
Children's Depression Inventory (CDI)
Tidsramme: 18-months post-intervention
|
Self-reported depression scores
|
18-months post-intervention
|
Children's Depression Inventory (CDI)
Tidsramme: 24-months post-intervention
|
Self-reported depression scores
|
24-months post-intervention
|
Children's Depression Inventory (CDI)
Tidsramme: 30-months post-intervention
|
Self-reported depression scores
|
30-months post-intervention
|
Children's Depression Inventory (CDI)
Tidsramme: 36-months post-intervention
|
Self-reported depression scores
|
36-months post-intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Children's Global Assessment Scale (CGAS)
Tidsramme: Post Intervention (approximately 3 months following baseline)
|
Assesses global functioning
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Post Intervention (approximately 3 months following baseline)
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Children's Global Assessment Scale (CGAS)
Tidsramme: 6-months followup
|
Assesses global functioning
|
6-months followup
|
Children's Global Assessment Scale (CGAS)
Tidsramme: 12-months followup
|
Assesses global functioning
|
12-months followup
|
Children's Global Assessment Scale (CGAS)
Tidsramme: 18-months followup
|
Assesses global functioning
|
18-months followup
|
Children's Global Assessment Scale (CGAS)
Tidsramme: 24-months followup
|
Assesses global functioning
|
24-months followup
|
Children's Global Assessment Scale (CGAS)
Tidsramme: 30-months followup
|
Assesses global functioning
|
30-months followup
|
Children's Global Assessment Scale (CGAS)
Tidsramme: 36-months followup
|
Assesses global functioning
|
36-months followup
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jami F Young, Ph.D., Children's Hospital of Philadelphia
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2013
Primær færdiggørelse (Faktiske)
1. august 2019
Studieafslutning (Faktiske)
1. august 2019
Datoer for studieregistrering
Først indsendt
18. september 2013
Først indsendt, der opfyldte QC-kriterier
18. september 2013
Først opslået (Skøn)
23. september 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. marts 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. marts 2021
Sidst verificeret
1. marts 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 17-013831
- R01MH077178 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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-
University of California, San FranciscoIkke rekrutterer endnuDepression Moderat | Depression MildForenede Stater
-
University of BernAfsluttetDepression Moderat | Depression MildSchweiz