UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040912 |
|---|---|
| Receipt number | 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 | 2022/07/01 05:26:51 |
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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
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
maria-nama@m.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo,
Faculty of Medicine,
School of International Health
Community and Global Health
Institute
Department
Personal name
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
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
Completed
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 | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046712
