UMIN-CTR 臨床試験登録情報の閲覧

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 2022/07/01 05:26:51

※ 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。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information

一般向け試験名/Public title

日本語


英語
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

日本語


英語
BRIDGE

科学的試験名/Scientific Title

日本語


英語
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

日本語


英語
BRIDGE

試験実施地域/Region

アフリカ/Africa


対象疾患/Condition

対象疾患名/Condition

日本語


英語
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

日本語


英語
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

日本語


英語

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

日本語


英語
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

日本語


英語
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

日本語


英語
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

日本語


英語
No training will be provided for controls

介入3/Interventions/Control_3

日本語


英語
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

日本語


英語
No intervention

介入5/Interventions/Control_5

日本語


英語

介入6/Interventions/Control_6

日本語


英語

介入7/Interventions/Control_7

日本語


英語

介入8/Interventions/Control_8

日本語


英語

介入9/Interventions/Control_9

日本語


英語

介入10/Interventions/Control_10

日本語


英語


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

日本語


英語
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

日本語


英語
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

日本語

ミドルネーム


英語
Masamine
ミドルネーム
Jimba

所属組織/Organization

日本語


英語
The University of Tokyo, Graduate School of Medicine

所属部署/Division name

日本語


英語
Department of Community and Global Health

郵便番号/Zip code

133-0033

住所/Address

日本語


英語
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

日本語

ミドルネーム


英語
Mariam
ミドルネーム
Namasaba

組織名/Organization

日本語


英語
The University of Tokyo, Graduate School of Medicine

部署名/Division name

日本語


英語
Department of Community and Global Health

郵便番号/Zip code

113-0033

住所/Address

日本語


英語
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


実施責任個人または組織/Sponsor or person

機関名/Institute

日本語
その他


英語
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)

日本語


部署名/Department

日本語


個人名/Personal name

日本語


英語


研究費提供組織/Funding Source

機関名/Organization

日本語
その他


英語
N/A

機関名/Organization
(機関選択不可の場合)

日本語


組織名/Division

日本語


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

日本語


英語
Uganda


その他の関連組織/Other related organizations

共同実施組織/Co-sponsor

日本語


英語
NA

その他の研究費提供組織/Name of secondary funder(s)

日本語


英語


IRB等連絡先(公開)/IRB Contact (For public release)

組織名/Organization

日本語


英語
The Research Ethics Committee of the Graduate School of Medicine, The University of Tokyo

住所/Address

日本語


英語
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

日本語


英語

試験ID2/Study ID_2


ID発行機関2/Org. issuing International ID_2

日本語


英語

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

日本語


英語
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

日本語


英語
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

日本語


英語
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

日本語


英語
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

日本語


英語
None

評価項目/Outcome measures

日本語


英語
coping skills
self-efficacy
mental well-being

個別症例データ共有計画/Plan to share IPD

日本語


英語
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

日本語


英語
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

試験終了/Completed

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

2022 05 05

入力終了(予定)日/Date of closure to data entry

2022 10 31

データ固定(予定)日/Date trial data considered complete

2022 10 31

解析終了(予定)日/Date analysis concluded

2022 10 31


その他/Other

その他関連情報/Other related information

日本語


英語


管理情報/Management information

登録日時/Registered date

2020 06 26

最終更新日/Last modified on

2022 07 01



閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046712


英語
https://center6.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