- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01948167
Bending Adolescent Depression Trajectories Through Personalized Prevention
2 mars 2021 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
205
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Colorado
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Denver, Colorado, Förenta staterna, 80208
- University of Denver
-
-
Illinois
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Champaign, Illinois, Förenta staterna, 61820
- University of Illinois Urbana Champaign
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New Jersey
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Piscataway, New Jersey, Förenta staterna, 08854
- Rutgers University
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19146
- Children's Hospital of Philadelphia
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
12 år till 17 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Andra namn:
|
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Experimentell: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: Post intervention (approximately 3 months after baseline)
|
Self-reported depression scores
|
Post intervention (approximately 3 months after baseline)
|
|
Children's Depression Inventory (CDI)
Tidsram: 6-months post-intervention
|
Self-reported depression scores
|
6-months post-intervention
|
|
Children's Depression Inventory (CDI)
Tidsram: 12-months post-intervention
|
Self-reported depression scores
|
12-months post-intervention
|
|
Children's Depression Inventory (CDI)
Tidsram: 18-months post-intervention
|
Self-reported depression scores
|
18-months post-intervention
|
|
Children's Depression Inventory (CDI)
Tidsram: 24-months post-intervention
|
Self-reported depression scores
|
24-months post-intervention
|
|
Children's Depression Inventory (CDI)
Tidsram: 30-months post-intervention
|
Self-reported depression scores
|
30-months post-intervention
|
|
Children's Depression Inventory (CDI)
Tidsram: 36-months post-intervention
|
Self-reported depression scores
|
36-months post-intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Children's Global Assessment Scale (CGAS)
Tidsram: Post Intervention (approximately 3 months following baseline)
|
Assesses global functioning
|
Post Intervention (approximately 3 months following baseline)
|
|
Children's Global Assessment Scale (CGAS)
Tidsram: 6-months followup
|
Assesses global functioning
|
6-months followup
|
|
Children's Global Assessment Scale (CGAS)
Tidsram: 12-months followup
|
Assesses global functioning
|
12-months followup
|
|
Children's Global Assessment Scale (CGAS)
Tidsram: 18-months followup
|
Assesses global functioning
|
18-months followup
|
|
Children's Global Assessment Scale (CGAS)
Tidsram: 24-months followup
|
Assesses global functioning
|
24-months followup
|
|
Children's Global Assessment Scale (CGAS)
Tidsram: 30-months followup
|
Assesses global functioning
|
30-months followup
|
|
Children's Global Assessment Scale (CGAS)
Tidsram: 36-months followup
|
Assesses global functioning
|
36-months followup
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Jami F Young, Ph.D., Children's Hospital of Philadelphia
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2013
Primärt slutförande (Faktisk)
1 augusti 2019
Avslutad studie (Faktisk)
1 augusti 2019
Studieregistreringsdatum
Först inskickad
18 september 2013
Först inskickad som uppfyllde QC-kriterierna
18 september 2013
Första postat (Uppskatta)
23 september 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 mars 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 mars 2021
Senast verifierad
1 mars 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 17-013831
- R01MH077178 (U.S.S. NIH-anslag/kontrakt)
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