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UMIN ID:

試験進捗状況 参加者募集終了‐試験継続中/No longer recruiting
UMIN試験ID UMIN000040912
受付番号 R000046712
科学的試験名
一般公開日(本登録希望日) 2021/06/23
最終更新日 2021/06/30

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
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基本情報/Basic information
一般向け試験名/Public title
A school-based resilience training program for caretakers of children with disabilities in Uganda: a cluster-randomized controlled trial
一般向け試験名略称/Acronym
BRIDGE
科学的試験名/Scientific Title
A school-based resilience training program for caretakers of children with disabilities in Uganda: a cluster randomized controlled trial
科学的試験名略称/Scientific Title:Acronym
BRIDGE
試験実施地域/Region
アフリカ/Africa

対象疾患/Condition
対象疾患名/Condition
Predisposition to stress and anxiety
疾患区分1/Classification by specialty
精神神経科学/Psychiatry 成人/Adult
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1
To examine the effect of a 6-month resilience training program on the mental well-being and coping skills and sense of self-efficacy among caretakers of children with disabilities
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 探索的/Exploratory
試験の性質2/Trial characteristics_2 実務的/Pragmatic
試験のフェーズ/Developmental phase 第Ⅰ・Ⅱ相/Phase I,II

評価/Assessment
主要アウトカム評価項目/Primary outcomes
The mental well-being of caretakers of children with disabilities, one month after completion of the training program
副次アウトカム評価項目/Key secondary outcomes
1. Self-reported coping skills of caretakers of children with disabilities in the last month prior to follow-up interviews

2. Self-reported sense of self-efficacy among school caretakers in the last month prior to follow-up interviews

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 集団/Cluster
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 無治療対照/No treatment
層別化/Stratification はい/YES
動的割付/Dynamic allocation いいえ/NO
試験実施施設の考慮/Institution consideration 施設をブロックとみなしている/Institution is considered as a block.
ブロック化/Blocking いいえ/NO
割付コードを知る方法/Concealment 準ランダム化/Pseudo-randomization

介入/Intervention
群数/No. of arms 4
介入の目的/Purpose of intervention 教育・カウンセリング・トレーニング/Educational,Counseling,Training
介入の種類/Type of intervention
行動・習慣/Behavior,custom
介入1/Interventions/Control_1
The intervention will be a multi-component resilience training program, carried out in two phases. The training sessions will be based on a modified, brief 5-step CBT process. This module has been chosen because it is the most adaptable for training between different groups and has shown efficacy in building resilience among non-clinical and workplace populations

In the first phase of the intervention, home and school caretakers in the intervention group will have separate bi-monthly sessions for an hour. The sessions will be facilitated by an occupational therapist and one psychiatric clinical officer who will guide caretakers to identify sustainable coping skills that can help them to adapt to the challenges they face. The goal of the first phase is to improve mental well-being, facilitate the use of adaptive coping skills, and improve the sense of self-efficacy among school caretakers.

The second phase of the intervention caretakers will have joint monthly group sessions for one hour and receive phone-based peer mentoring from a group mentor, who is also a peer. The aim of the second phase is to provide tailor-made training for each individual. In the joint group sessions, home caretakers and school caretakers will share their expectations of each other and learn from their peers through discussions. One occupational therapist and a psychiatric clinical officer will facilitate open communication between home caretakers and school caretakers. Each group will have an assigned mentor to provide personalized support and to each member of the group over three months of the intervention.


介入2/Interventions/Control_2
No training will be provided for controls
介入3/Interventions/Control_3
As a pilot study to test feasibility, we will recruit 2 schools (40 caretakers). One school will be assigned to the intervention and another to the control arm. We will aim to recruit a minimum of 20 caretakers in each school. Thus, a multi-component resilience training program will be conducted as an intervention for 4 weeks.
Before delivering the intervention, we will collect data on coping skills, mental well-being, and sense of self-efficacy. After data collection, we will then recruit participants into the intervention.
In the first phase of the intervention, home and school caretakers in the intervention group will have separate weekly sessions for an hour. The sessions will be facilitated by an occupational therapist who will guide caretakers to identify sustainable coping skills that can help them adapt to their challenges.
In the second phase of the intervention, caretakers will receive phone-based peer mentoring for two weeks from a group mentor, who is also a peer. The second phase aims to provide individualized care for everyone. A peer mentor will make a phone call to their mentor in the third week and send a message in the fourth week.
After four weeks of the program, we will collect follow-up data on mental well-being and a sense of self-efficacy. The pre-and post-results of the study will be used to check the feasibility of the main study. In addition, we will use the results to modify the delivery and content of the intervention, questionnaires, recruitment, retention, and data collection methods. Any changes made will be reported to ethic review committees, and the registered protocol will be updated.
介入4/Interventions/Control_4
No intervention
介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
18 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
80 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
Caretakers of children with disabilities in schools within Kampala district, Uganda.

Caretakers who have lived with a child for at least six months prior to the study
除外基準/Key exclusion criteria
Caretakers who have no direct role in taking care of a child with disabilities
目標参加者数/Target sample size 952

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

Masamine
ミドルネーム
Jimba
所属組織/Organization
The University of Tokyo, Graduate School of Medicine
所属部署/Division name
Department of Community and Global Health
郵便番号/Zip code 133-0033
住所/Address
7-3-1 Hongo, Bunkyo-ku
電話/TEL 03-5842-3698
Email/Email maria-nama@m.u-tokyo.ac.jp

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

Mariam
ミドルネーム
Namasaba
組織名/Organization
The University of Tokyo, Graduate School of Medicine
部署名/Division name
Department of Community and Global Health
郵便番号/Zip code 113-0033
住所/Address
7-3-1 Hongo, Bunkyo-ku
電話/TEL +81-70-1432-2150
試験のホームページURL/Homepage URL
Email/Email maria-nama@m.u-tokyo.ac.jp

実施責任組織/Sponsor
機関名/Institute その他 The University of Tokyo,
Faculty of Medicine,


School of International Health



Community and Global Health
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 N/A
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization
Uganda

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor
NA
その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
The Research Ethics Committee of the Graduate School of Medicine, The University of Tokyo
住所/Address
7-3-1 Hongo, Bunkyo-ku, 113-0033
電話/Tel +81-3-5841-3698
Email/Email ethics@m.u-tokyo.ac.jp

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions Mulago school for the deaf (Kampala), Ntida school for the deaf(Kampala), Early Childhood Learning Center (Kampala), Kyambogo primary school (Kampala), Kireka Grammar (Kampala), Kazo school (Kampala), Hill Preparatory school (Kampala), Hassan Tourabi (Kampala), Goodwill school (Kampala), Mukisa Foundation (Kampala)

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2021 06 23

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled 540
主な結果/Results
Below are the details of participants recruited for both the pilot and main study.


Pilot study


Recruitment
Home caretakers: 20
School caretakers: 20



Main study

Recruitment
Home caretakers:400
School caretaker: 100

A total number of participants recruited (pilot and main study:540

主な結果入力日/Results date posted
2021 06 23
結果掲載遅延/Results Delayed
遅れる予定/Delay expected
結果遅延理由/Results Delay Reason
Due to renewed total lock-down in Uganda, delivery of the intervention will be stopped for 42 in order to comply with government regulations. As such data collection and analysis will be delayed
最初の試験結果の出版日/Date of the first journal publication of results
2022 06 05
参加者背景/Baseline Characteristics
Intervention arm: 6 schools
mean age of caretakers(mean; SD) = 36.4; 11.4
meean age of children (mean; SD) = 12.3 ; 4.2
School types = 4 inclusive schools, 2 special needs school

Control arm: 5 schools

Mean age of ccaretakes (mean; SD) = 42.7; 10.6
Mean age of children (mean; SD )= 13.7 ; 3.5
School types = 1 special needs, 5 inclusive schools



参加者の流れ/Participant flow
12 schools were recruited. One school has dropped out after allocation due to the school's administrative preference.

Participants were recruited using convenience sampling and will receive the intervention according to the assignment of their schools.
有害事象/Adverse events
None
評価項目/Outcome measures
coping skills
self-efficacy
mental well-being
個別症例データ共有計画/Plan to share IPD
The results will be shared as a Ph.D. dissertation and published in international journals
個別症例データ共有計画の詳細/IPD sharing Plan description
The results will be shared as a Ph.D. dissertation and published in international journals

試験進捗状況/Progress
試験進捗状況/Recruitment status 参加者募集終了‐試験継続中/No longer recruiting
プロトコル確定日/Date of protocol fixation
2020 06 25
倫理委員会による承認日/Date of IRB
2021 01 15
登録・組入れ開始(予定)日/Anticipated trial start date
2021 03 31
フォロー終了(予定)日/Last follow-up date
2021 08 31
入力終了(予定)日/Date of closure to data entry
2021 08 31
データ固定(予定)日/Date trial data considered complete
2021 10 31
解析終了(予定)日/Date analysis concluded
2021 10 31

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2020 06 26
最終更新日/Last modified on
2021 06 30


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046712
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046712

研究計画書
登録日時 ファイル名
2021/06/23 Protocol draft_June23.docx

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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