- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01948167
Bending Adolescent Depression Trajectories Through Personalized Prevention
2. mars 2021 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
205
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Colorado
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Denver, Colorado, Forente stater, 80208
- University of Denver
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Illinois
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Champaign, Illinois, Forente stater, 61820
- University of Illinois Urbana Champaign
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New Jersey
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Piscataway, New Jersey, Forente stater, 08854
- Rutgers University
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19146
- Children's Hospital of Philadelphia
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
12 år til 17 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
Andre navn:
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Eksperimentell: 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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
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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)
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.
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36-months post-intervention
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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
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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)
Tidsramme: 12-months post-intervention
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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
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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
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36-months post-intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Children's Global Assessment Scale (CGAS)
Tidsramme: 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)
Tidsramme: 6-months followup
|
Assesses global functioning
|
6-months followup
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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
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36-months followup
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jami F Young, Ph.D., Children's Hospital of Philadelphia
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2013
Primær fullføring (Faktiske)
1. august 2019
Studiet fullført (Faktiske)
1. august 2019
Datoer for studieregistrering
Først innsendt
18. september 2013
Først innsendt som oppfylte QC-kriteriene
18. september 2013
Først lagt ut (Anslag)
23. september 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. mars 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. mars 2021
Sist bekreftet
1. mars 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 17-013831
- R01MH077178 (U.S. NIH-stipend/kontrakt)
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