Bending Adolescent Depression Trajectories Through Personalized Prevention
2021年3月2日 更新者: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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
205
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Colorado
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Denver、Colorado、アメリカ、80208
- University of Denver
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Illinois
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Champaign、Illinois、アメリカ、61820
- University of Illinois Urbana Champaign
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New Jersey
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Piscataway、New Jersey、アメリカ、08854
- Rutgers University
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19146
- Children's Hospital of Philadelphia
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
12年~17年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的: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.
他の名前:
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実験的: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.
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
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)
時間枠:Post intervention (approximately 3 months post baseline)
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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)
時間枠:6-months post-intervention
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Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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6-months post-intervention
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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)
時間枠:12-months post-intervention
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Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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12-months post-intervention
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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)
時間枠:18-months post-intervention
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Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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18-months post-intervention
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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)
時間枠:24-months post-intervention
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Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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24-months post-intervention
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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)
時間枠:30-months post-intervention
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Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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30-months post-intervention
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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)
時間枠:36-months post-intervention
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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)
時間枠: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)
時間枠: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)
時間枠:12-months post-intervention
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Self-reported depression scores
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12-months post-intervention
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Children's Depression Inventory (CDI)
時間枠:18-months post-intervention
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Self-reported depression scores
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18-months post-intervention
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Children's Depression Inventory (CDI)
時間枠:24-months post-intervention
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Self-reported depression scores
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24-months post-intervention
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Children's Depression Inventory (CDI)
時間枠:30-months post-intervention
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Self-reported depression scores
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30-months post-intervention
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Children's Depression Inventory (CDI)
時間枠:36-months post-intervention
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Self-reported depression scores
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36-months post-intervention
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Children's Global Assessment Scale (CGAS)
時間枠: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)
時間枠:6-months followup
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Assesses global functioning
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6-months followup
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Children's Global Assessment Scale (CGAS)
時間枠:12-months followup
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Assesses global functioning
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12-months followup
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Children's Global Assessment Scale (CGAS)
時間枠:18-months followup
|
Assesses global functioning
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18-months followup
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Children's Global Assessment Scale (CGAS)
時間枠:24-months followup
|
Assesses global functioning
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24-months followup
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Children's Global Assessment Scale (CGAS)
時間枠:30-months followup
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Assesses global functioning
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30-months followup
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Children's Global Assessment Scale (CGAS)
時間枠:36-months followup
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Assesses global functioning
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36-months followup
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者:Jami F Young, Ph.D.、Children's Hospital of Philadelphia
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年9月1日
一次修了 (実際)
2019年8月1日
研究の完了 (実際)
2019年8月1日
試験登録日
最初に提出
2013年9月18日
QC基準を満たした最初の提出物
2013年9月18日
最初の投稿 (見積もり)
2013年9月23日
学習記録の更新
投稿された最後の更新 (実際)
2021年3月4日
QC基準を満たした最後の更新が送信されました
2021年3月2日
最終確認日
2021年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Interpersonal Psychotherapy- Adolescent Skills Trainingの臨床試験
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Queens College, The City University of New York完了