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 |
日本語
英語
A school-based resilience training program for caretakers of children with disabilities in Uganda: a cluster-randomized controlled trial
日本語
英語
BRIDGE
日本語
英語
A school-based resilience training program for caretakers of children with disabilities in Uganda: a cluster randomized controlled trial
日本語
英語
BRIDGE
アフリカ/Africa |
日本語
英語
Predisposition to stress and anxiety
精神神経科学/Psychiatry | 成人/Adult |
悪性腫瘍以外/Others
いいえ/NO
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
有効性/Efficacy
日本語
英語
探索的/Exploratory
実務的/Pragmatic
第Ⅰ・Ⅱ相/Phase I,II
日本語
英語
The mental well-being of caretakers of children with disabilities, one month after completion of the training program
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
介入/Interventional
並行群間比較/Parallel
ランダム化/Randomized
集団/Cluster
オープン/Open -no one is blinded
無治療対照/No treatment
はい/YES
いいえ/NO
施設をブロックとみなしている/Institution is considered as a block.
いいえ/NO
準ランダム化/Pseudo-randomization
4
教育・カウンセリング・トレーニング/Educational,Counseling,Training
行動・習慣/Behavior,custom |
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.
日本語
英語
No training will be provided for controls
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.
日本語
英語
No intervention
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
18 | 歳/years-old | 以上/<= |
80 | 歳/years-old | 以下/>= |
男女両方/Male and Female
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
日本語
英語
Caretakers who have no direct role in taking care of a child with disabilities
952
日本語
名 | |
ミドルネーム | |
姓 |
英語
名 | Masamine |
ミドルネーム | |
姓 | Jimba |
日本語
英語
The University of Tokyo, Graduate School of Medicine
日本語
英語
Department of Community and Global Health
133-0033
日本語
英語
7-3-1 Hongo, Bunkyo-ku
03-5842-3698
maria-nama@m.u-tokyo.ac.jp
日本語
名 | |
ミドルネーム | |
姓 |
英語
名 | Mariam |
ミドルネーム | |
姓 | Namasaba |
日本語
英語
The University of Tokyo, Graduate School of Medicine
日本語
英語
Department of Community and Global Health
113-0033
日本語
英語
7-3-1 Hongo, Bunkyo-ku
+81-70-1432-2150
maria-nama@m.u-tokyo.ac.jp
日本語
その他
英語
The University of Tokyo,
Faculty of Medicine,
School of International Health
Community and Global Health
日本語
日本語
日本語
英語
日本語
その他
英語
N/A
日本語
日本語
自己調達/Self funding
日本語
英語
Uganda
日本語
英語
NA
日本語
英語
日本語
英語
The Research Ethics Committee of the Graduate School of Medicine, The University of Tokyo
日本語
英語
7-3-1 Hongo, Bunkyo-ku, 113-0033
+81-3-5841-3698
ethics@m.u-tokyo.ac.jp
いいえ/NO
日本語
英語
日本語
英語
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)
2021 | 年 | 06 | 月 | 23 | 日 |
未公表/Unpublished
540
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
2021 | 年 | 06 | 月 | 23 | 日 |
遅れる予定/Delay expected |
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
2022 | 年 | 06 | 月 | 05 | 日 |
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
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.
日本語
英語
None
日本語
英語
coping skills
self-efficacy
mental well-being
日本語
英語
The results will be shared as a Ph.D. dissertation and published in international journals
日本語
英語
The results will be shared as a Ph.D. dissertation and published in international journals
試験終了/Completed
2020 | 年 | 06 | 月 | 25 | 日 |
2021 | 年 | 01 | 月 | 15 | 日 |
2021 | 年 | 03 | 月 | 31 | 日 |
2022 | 年 | 05 | 月 | 05 | 日 |
2022 | 年 | 10 | 月 | 31 | 日 |
2022 | 年 | 10 | 月 | 31 | 日 |
2022 | 年 | 10 | 月 | 31 | 日 |
日本語
英語
2020 | 年 | 06 | 月 | 26 | 日 |
2022 | 年 | 07 | 月 | 01 | 日 |
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 |