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A School-based Intervention Project to Increase Completion of Upper Secondary School in Norway (COMPLETE)

2020年3月24日更新者：Torill Bogsnes Larsen、University of Bergen

COMPLETE - a School-based Intervention Project to Improve Psychosocial Learning Environments and Increase Completion of Upper Secondary School in Norway: a Cluster Randomized Controlled Trial

Drop out from upper secondary school represents a risk for the future health and wellbeing of young people. Strengthening of psychosocial aspects of the learning environment may be an effective strategy to promote completion of upper secondary school. The COMPLETE study is a school based cluster randomized controlled trial (RCT) evaluating two school-based interventions, namely the Dream School Program (DSP) and the Mental Health Support Team (MHST) among 1st grade upper secondary school students in four counties in Norway. The interventions aim to improve psychosocial learning environments and subsequently school achievements and decrease drop-out and absence.

Specifically, the COMPLETE study will

Evaluate whether the DSP alone
1. increases completion
2. increases presence
3. improves school achievements
4. improves mental health and wellbeing
Evaluate whether the DSP and the MHST combined
1. increase completion
2. increase presence
3. improve school achievements
4. improve mental health and wellbeing
The COMPLETE study will also evaluate the effect of the DSP and MHST combined and the DSP alone against secondary outcomes of school satisfaction and loneliness.
Evaluate through a process evaluation whether the interventions were implemented in line with guidelines for each of the interventions, and whether the degree of program fidelity has influenced the effect of the interventions on the primary and secondary outcomes.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

3500

段階

適用できない

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

15年歳以上 (子、大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

School inclusion criteria: not been or currently involved in either of the Dream School Program or the Mental Health Support Team or similar programs or research projects
Student inclusion criteria: student enrolled at any of the included schools.

Exclusion Criteria:

Schools previously or currently involved in either of the Dream School Program or the Mental Health Support Team or similar programs or research projects.
Student exclusion criteria: students with special needs or who are illiterate in Norwegian are excluded from the survey assessment, but included in the interventions.

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：なし（オープンラベル）

アーム数

武器と介入

参加者グループ / アーム	介入・治療
実験的：Dream School Program (DSP) The Dream School Program is a whole school program, involving staff and students, with the aim of creating learning environments where students are confident and experience a sense of belonging, and where mental health is promoted.	他の：Dream School Program The Dream School program is a whole school program, involving staff and students, with the aim of creating learning environments where students are confident and experience a sense of belonging, and where mental health is promoted. 他の名前： Drømmeskolen (Norwegian name)
実験的：DSP and Mental Health Support Team A combination of the universal Dream Schoop Program (see description above) and the selective/indicative intervention Mental Health Support Team which is aimed at specific students at risk of dropping out of upper secondary school. It is a systematization of the student services through Co-location of services and staff working in services "One open door" to increase accessibility to the services and staff for students Focus on the transition from lower to upper secondary school Close follow-up of students at risk to ensure tailored help to each student Early intervention and follow up when students starts being absent from school	他の：Dream School Program The Dream School program is a whole school program, involving staff and students, with the aim of creating learning environments where students are confident and experience a sense of belonging, and where mental health is promoted. 他の名前： Drømmeskolen (Norwegian name) 他の：Mental Health Support Team MHST is also a whole school project but aimed at specific students at risk of dropping out. It is a systematisation of the student services through Co-location of services and staff working in services "One open door" to increase accessibility to the services and staff for students Focus on the transition from lower to upper secondary school Close follow-up of students at risk to ensure tailored help to each student Early intervention and follow up when students starts being absent from school This work demands cross- and multidisciplinary collaborations within the MHST, between MHST and school leadership, and between lower and upper secondary schools. 他の名前： Nærværsteam (Norwegian name)
介入なし：Control The control group are upper secondary schools who run classes and the school as usual, and do not introduce new programs similar to the Dream School or Mental Health Support Team during the project period.

この研究は何を測定していますか？

主要な結果の測定

二次結果の測定

結果測定	メジャーの説明	時間枠
Change from baseline School satisfaction at 6 months 時間枠：Based on self-report in survey assessment at baseline and 6, 18 and 30 months	Three items from the School Satisfaction Scale, a subscale of the Multidimensional Student's Life Satisfaction Scale. 5 point Likert scale from Completely disagree to Completely agree, with higher values indicating a better outcome.	Based on self-report in survey assessment at baseline and 6, 18 and 30 months
Change from baseline School satisfaction at 18 months 時間枠：Based on self-report in survey assessment at baseline and 18 months	Three items from the School Satisfaction Scale, a subscale of the Multidimensional Student's Life Satisfaction Scale. 5 point Likert scale from Completely disagree to Completely agree, with higher values indicating a better outcome.	Based on self-report in survey assessment at baseline and 18 months
Change from baseline School satisfaction at 30 months 時間枠：Based on self-report in survey assessment at baseline and 30 months	Three items from the School Satisfaction Scale, a subscale of the Multidimensional Student's Life Satisfaction Scale. 5 point Likert scale from Completely disagree to Completely agree, with higher values indicating a better outcome.	Based on self-report in survey assessment at baseline and 30 months
Change from baseline Loneliness at 6 months 時間枠：Based on self-report in survey assessment at baseline and 6 months	Loneliness Scale, 5 point Likert scale from Not at all to To a very high degree with higher values indicating a worse outcome.	Based on self-report in survey assessment at baseline and 6 months
Change from baseline Loneliness at 18 months 時間枠：Based on self-report in survey assessment at baseline and 18 months	Loneliness Scale, 5 point Likert scale from Not at all to To a very high degree with higher values indicating a worse outcome.	Based on self-report in survey assessment at baseline and 18 months
Change from baseline Loneliness at 30 months 時間枠：Based on self-report in survey assessment at baseline and 30 months	Loneliness Scale, 5 point Likert scale from Not at all to To a very high degree with higher values indicating a worse outcome.	Based on self-report in survey assessment at baseline and 30 months

その他の成果指標

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。

スポンサー

University of Bergen

協力者

Oxford Research

Nordland Research Institute

Voksne for Barn

Bodin Upper Secondary School

Troms county

Nordland county

Sogn og Fjordane county

Hordaland county

捜査官

主任研究者：Torill B Larsen, PhD、University of Bergen

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。

一般刊行物

Larsen T, Urke HB, Holsen I, Anvik CH, Olsen T, Waldahl RH, Antonsen KM, Johnson R, Tobro M, Brastad B, Hansen TB. COMPLETE - a school-based intervention project to increase completion of upper secondary school in Norway: study protocol for a cluster randomized controlled trial. BMC Public Health. 2018 Mar 9;18(1):340. doi: 10.1186/s12889-018-5241-z.

便利なリンク

COMPLETE project web site

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 (実際)

2016年2月1日

一次修了 (実際)

2019年10月31日

研究の完了 (実際)

2020年2月12日

試験登録日

最初に提出

2017年11月30日

QC基準を満たした最初の提出物

2017年12月18日

最初の投稿 (実際)

2017年12月22日

学習記録の更新

投稿された最後の更新 (実際)

2020年3月25日

QC基準を満たした最後の更新が送信されました

2020年3月24日

最終確認日

2020年3月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

20161789

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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。

メンタルヘルスの臨床試験

University of Colorado, Denver
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National... と他の協力者

積極的、募集していない

推定でワクチン接種を開始し、動機づけ面接による最適化の会話 (PIVOT with MI)

予防医療サービス (PREV HEALTH SERV)

アメリカ
Queens College, The City University of New York

募集

トリプルマスキング vs ダブルマスキング: 公衆衛生における科学出版の試み (TripleMasking)

American Journal of Public Healthに投稿された論文の出版

アメリカ
Istanbul University - Cerrahpasa (IUC)

募集

心臓手術後の回復と生活の質に対する退院教育プログラムの効果

心臓外科、心臓外科、退院教育、看護、遠隔看護、m-Health、生活の質、回復

七面鳥

Dream School Programの臨床試験

Florida International University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

完了

問題行動のある幼児の健康的なスクリーンタイムの習慣を促進するために子育て介入を適応させる

子育て | 動作の問題

アメリカ
Children's Hospital Los Angeles
Robert Wood Johnson Foundation

募集

フィリピン家族健康イニシアチブ

子育て | 教育 | 家族関係

アメリカ
Dreem

完了

不眠症集団における在宅睡眠モニタリングのためのDreem 3システムの堅牢性と使いやすさ。

睡眠開始および睡眠維持障害 | 寝る | 睡眠障害 | 不眠症、二次

アメリカ
University of Minho

完了

脆弱な学校への健康増進介入 (BeE-school)

肥満 | 健康増進 | 小児発達 | 非伝染性疾患 | ライフスタイル

ポルトガル
Hannover Medical School

募集

REBIRTH アクティブスクール 2.0 .学校ベースの身体活動プログラム (RAS2)

小学生

ドイツ
University of British Columbia

完了

乳児の勉強を助ける親: 乳児の早期泣き声に関する新しい親の知識、態度、行動を変えるための教育的介入

揺さぶられっ子症候群

カナダ
London School of Hygiene and Tropical Medicine
Hindustan Unilever Ltd.

完了

Unilever Lifebuoy による学校ベースの手洗いキャンペーン (School Of 5) の評価 (インド、ビハール州農村部)

下痢

インド
Universitaire Ziekenhuizen KU Leuven
CHU UCL Namur

まだ募集していません

老人ホームリハビリテーション後の障害からの回復と標準治療: パイロット研究 (RECOVER@HOME)

身体障害者

ベルギー
Children's Health

完了

Listening Program® with Bone Conduction Headphones は、音に対する過敏症と行動反応を変化させます

自閉症スペクトラム障害

アメリカ
University of Aarhus
TRYG Foundation

わからない

社交不安障害の青年に対する認知行動療法

社交不安障害

デンマーク

結果測定	メジャーの説明	時間枠
Drop-out 時間枠：Each participant is assessed after 10 months	If the student has not complete upper secondary school within five years or if the student quit school and is without any regular activity during the course of the study period, i.e. grade 1-3 of upper secondary school	Each participant is assessed after 10 months
Drop-out 時間枠：Each participant is assessed after 22 months	If the student has not complete upper secondary school within five years or if the student quit school and is without any regular activity during the course of the study period, i.e. grade 1-3 of upper secondary school	Each participant is assessed after 22 months
Drop-out 時間枠：Each participant is assessed after 34 months	If the student has not complete upper secondary school within five years or if the student quit school and is without any regular activity during the course of the study period, i.e. grade 1-3 of upper secondary school	Each participant is assessed after 34 months
Drop-out 時間枠：Each participant is assessed after 58 months	If the student has not complete upper secondary school within five years or if the student quit school and is without any regular activity during the course of the study period, i.e. grade 1-3 of upper secondary school	Each participant is assessed after 58 months
Absence 時間枠：Each participant is assessed after 10 months	Total days and hours absent at closure of first school year in upper secondary school	Each participant is assessed after 10 months
Absence 時間枠：Each participant is assessed after 22 months	Total days and hours absent at closure of second school year in upper secondary school	Each participant is assessed after 22 months
Absence 時間枠：Each participant is assessed after 34 months	Total days and hours absent at closure of third school year in upper secondary school	Each participant is assessed after 34 months
Academic achievement 時間枠：Each participant is assessed after 10 months	Average grade at closure of first school year in upper secondary school	Each participant is assessed after 10 months
Academic achievement 時間枠：Each participant is assessed after 22 months	Average grade at closure of second school year in upper secondary school	Each participant is assessed after 22 months
Academic achievement 時間枠：Each participant is assessed after 34 months	Average grade at closure of third school year in upper secondary school	Each participant is assessed after 34 months
Change from baseline Mental Health at 6 months 時間枠：Based on self-report in survey assessment at baseline and 6 months	Short form of Symptom Check List (SCL-5), on a 4 point Likert scale ranging from Not bothered to Very bothered, with higher values indicating a worse outcome.	Based on self-report in survey assessment at baseline and 6 months
Change from baseline Mental Health at 18 months 時間枠：Based on self-report in survey assessment at baseline and 18 months	Short form of Symptom Check List (SCL-5), on a 4 point Likert scale ranging from Not bothered to Very bothered, with higher values indicating a worse outcome.	Based on self-report in survey assessment at baseline and 18 months
Change from baseline Mental Health at 30 months 時間枠：Based on self-report in survey assessment at baseline and 30 months	Short form of Symptom Check List (SCL-5), on a 4 point Likert scale ranging from Not bothered to Very bothered, with higher values indicating a worse outcome.	Based on self-report in survey assessment at baseline and 30 months
Change in Mental Wellbeing from baseline at 6 months 時間枠：Based on self-report in survey assessment at baseline and 6 months	Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), on a 5 point Likert scale from None of the time to All of the time, with higher values indicating a better outcome	Based on self-report in survey assessment at baseline and 6 months
Change from baseline Mental Wellbeing at 18 months 時間枠：Based on self-report in survey assessment at baseline and 18 months	Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), on a 5 point Likert scale from None of the time to All of the time, with higher values indicating a better outcome	Based on self-report in survey assessment at baseline and 18 months

結果測定	メジャーの説明	時間枠
Change from baseline Social competence at 6 months 時間枠：Based on self-report in survey assessment at baseline and 6 months	Wichstrøm Social Competence Scale, a 4 point Likert scale ranging from Describes me very poorly to Describes me very well, with higher values indicating a better outcome.	Based on self-report in survey assessment at baseline and 6 months
Change from baseline Social competence at 30 months 時間枠：Based on self-report in survey assessment at baseline and 30 months	Wichstrøm Social Competence Scale, a 4 point Likert scale ranging from Describes me very poorly to Describes me very well, with higher values indicating a better outcome.	Based on self-report in survey assessment at baseline and 30 months
Change from baseline Social competence at 18 months 時間枠：Based on self-report in survey assessment at baseline and 18 months	Wichstrøm Social Competence Scale, a 4 point Likert scale ranging from Describes me very poorly to Describes me very well, with higher values indicating a better outcome.	Based on self-report in survey assessment at baseline and 18 months
Change from baseline Relatedness at 6 months 時間枠：Based on self-report in survey assessment at baseline and 6 months	Teacher and Classmate Support Scale, a 5 point Likert scale ranging from Completely disagree to Completely agree, with higher values indicating a better outcome.	Based on self-report in survey assessment at baseline and 6 months
Change from baseline Relatedness at 18 months 時間枠：Based on self-report in survey assessment at baseline and 18 months	Teacher and Classmate Support Scale, a 5 point Likert scale ranging from Completely disagree to Completely agree, with higher values indicating a better outcome.	Based on self-report in survey assessment at baseline and 18 months
Change from baseline Relatedness: support at 30 months 時間枠：Based on self-report in survey assessment at baseline and 30 months	Teacher and Classmate Support Scale, a 5 point Likert scale ranging from Completely disagree to Completely agree, with higher values indicating a better outcome.	Based on self-report in survey assessment at baseline and 30 months
Change from baseline Relatedness: peer connection at 6 months 時間枠：Based on self-report in survey assessment at baseline and 6 months	Positive Youth Development Connection Scale, on a 5 point Likert scale, ranging from Almost never or never true to Always true, with higher values indicating a better outcome.	Based on self-report in survey assessment at baseline and 6 months
Change from baseline Peer connection at 18 months 時間枠：Based on self-report in survey assessment at baseline and 18 months	Positive Youth Development Connection Scale, on a 5 point Likert scale, ranging from Almost never or never true to Always true, with higher values indicating a better outcome.	Based on self-report in survey assessment at baseline and 18 months
Change from baseline Peer connection at 30 months 時間枠：Based on self-report in survey assessment at baseline and 30 months	Positive Youth Development Connection Scale, on a 5 point Likert scale, ranging from Almost never or never true to Always true, with higher values indicating a better outcome.	Based on self-report in survey assessment at baseline and 30 months
Change from baseline Autonomy support at 6 months 時間枠：Based on self-report in survey assessment at baseline and 6 months	Ten items from the Learning Climate Scale, a 5 point Likert scale ranging from Strongly disagree to Strongly agree, with higher values indicating a better outcome.	Based on self-report in survey assessment at baseline and 6 months
Change from baseline Autonomy support at 18 months 時間枠：Based on self-report in survey assessment at baseline and 18 months	Ten items from the Learning Climate Scale, a 5 point Likert scale ranging from Strongly disagree to Strongly agree, with higher values indicating a better outcome.	Based on self-report in survey assessment at baseline and 18 months
Change from baseline Autonomy support at 30 months 時間枠：Based on self-report in survey assessment at baseline and 30 months	Ten items from the Learning Climate Scale, a 5 point Likert scale ranging from Strongly disagree to Strongly agree, with higher values indicating a better outcome.	Based on self-report in survey assessment at baseline and 30 months
Change from baseline Academic competence at 6 months 時間枠：Based on self-report in survey assessment at baseline and 6 months	Academic Self-Efficacy Scale, a 5 point Likert scale ranging from Completely disagree to Completely agree, with higher values indicating a better outcome.	Based on self-report in survey assessment at baseline and 6 months
Change from baseline Academic competence at 18 months 時間枠：Based on self-report in survey assessment at baseline and 18 months	Academic Self-Efficacy Scale, a 5 point Likert scale ranging from Completely disagree to Completely agree, with higher values indicating a better outcome.	Based on self-report in survey assessment at baseline and 18 months
Change from baseline Academic competence at 30 months 時間枠：Based on self-report in survey assessment at baseline and 30 months	Academic Self-Efficacy Scale, a 5 point Likert scale ranging from Completely disagree to Completely agree, with higher values indicating a better outcome.	Based on self-report in survey assessment at baseline and 30 months
Class climate 時間枠：Based on self-report in survey assessment at baseline	Caring Climate Scale, on a 5 point Likert scale, ranging from Strongly disagree to Strongly agree, with higher values indicating a better outcome.	Based on self-report in survey assessment at baseline
Change from 6 month Class climate at 18 months 時間枠：Based on self-report in survey assessment at 6 and 18 months	Caring Climate Scale, on a 5 point Likert scale, ranging from Strongly disagree to Strongly agree, with higher values indicating a better outcome.	Based on self-report in survey assessment at 6 and 18 months
Change from 6 month Class climate at 30 months 時間枠：Based on self-report in survey assessment at 6 and 30 months	Caring Climate Scale, on a 5 point Likert scale, ranging from Strongly disagree to Strongly agree, with higher values indicating a better outcome.	Based on self-report in survey assessment at 6 and 30 months

A School-based Intervention Project to Increase Completion of Upper Secondary School in Norway (COMPLETE)

COMPLETE - a School-based Intervention Project to Improve Psychosocial Learning Environments and Increase Completion of Upper Secondary School in Norway: a Cluster Randomized Controlled Trial

調査の概要

状態

条件

介入・治療

研究の種類

入学 (実際)

段階

参加基準

適格基準

就学可能な年齢

健康ボランティアの受け入れ

受講資格のある性別

説明

研究計画

研究はどのように設計されていますか？

デザインの詳細

アーム数

武器と介入

参加者グループ / アーム

介入・治療

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

二次結果の測定

結果測定

メジャーの説明

時間枠

その他の成果指標

結果測定

メジャーの説明

時間枠

協力者と研究者

スポンサー

協力者

捜査官

出版物と役立つリンク

一般刊行物

便利なリンク

研究記録日

主要日程の研究

研究開始 (実際)

一次修了 (実際)

研究の完了 (実際)

試験登録日

最初に提出

QC基準を満たした最初の提出物

最初の投稿 (実際)

学習記録の更新

投稿された最後の更新 (実際)

QC基準を満たした最後の更新が送信されました

最終確認日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

米国FDA規制機器製品の研究

メンタルヘルスの臨床試験

Dream School Programの臨床試験

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Sri Lanka

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所