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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040912
Receipt No. R000046712
Scientific Title A school-based resilience training program for caretakers of children with disabilities in Uganda: a cluster randomized controlled trial
Date of disclosure of the study information 2021/06/23
Last modified on 2022/01/02

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Basic information
Public title A school-based resilience training program for caretakers of children with disabilities in Uganda: a cluster-randomized controlled trial
Acronym BRIDGE
Scientific Title A school-based resilience training program for caretakers of children with disabilities in Uganda: a cluster randomized controlled trial
Scientific Title:Acronym BRIDGE
Region
Africa

Condition
Condition Predisposition to stress and anxiety
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
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
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes The mental well-being of caretakers of children with disabilities, one month after completion of the training program
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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 4
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
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.


Interventions/Control_2 No training will be provided for controls
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.
Interventions/Control_4 No intervention
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
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
Key exclusion criteria Caretakers who have no direct role in taking care of a child with disabilities
Target sample size 952

Research contact person
Name of lead principal investigator
1st name Masamine
Middle name
Last name Jimba
Organization The University of Tokyo, Graduate School of Medicine
Division name Department of Community and Global Health
Zip code 133-0033
Address 7-3-1 Hongo, Bunkyo-ku
TEL 03-5842-3698
Email maria-nama@m.u-tokyo.ac.jp

Public contact
Name of contact person
1st name Mariam
Middle name
Last name Namasaba
Organization The University of Tokyo, Graduate School of Medicine
Division name Department of Community and Global Health
Zip code 113-0033
Address 7-3-1 Hongo, Bunkyo-ku
TEL +81-70-1432-2150
Homepage URL
Email maria-nama@m.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo,
Faculty of Medicine,


School of International Health



Community and Global Health
Institute
Department

Funding Source
Organization N/A
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Uganda

Other related organizations
Co-sponsor NA
Name of secondary funder(s)

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

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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)

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 540
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

Results date posted
2021 Year 06 Month 23 Day
Results Delayed
Delay expected
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
Date of the first journal publication of results
2022 Year 06 Month 05 Day
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



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.
Adverse events None
Outcome measures coping skills
self-efficacy
mental well-being
Plan to share IPD The results will be shared as a Ph.D. dissertation and published in international journals
IPD sharing Plan description The results will be shared as a Ph.D. dissertation and published in international journals

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2020 Year 06 Month 25 Day
Date of IRB
2021 Year 01 Month 15 Day
Anticipated trial start date
2021 Year 03 Month 31 Day
Last follow-up date
2022 Year 05 Month 05 Day
Date of closure to data entry
2022 Year 10 Month 31 Day
Date trial data considered complete
2022 Year 10 Month 31 Day
Date analysis concluded
2022 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2020 Year 06 Month 26 Day
Last modified on
2022 Year 01 Month 02 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046712

Research Plan
Registered date File name
2021/06/23 Protocol draft_June23.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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