UMIN-CTR Clinical Trial

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

Predisposition to stress and anxiety

Classification by specialty

Psychiatry

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

The University of Tokyo,
Faculty of Medicine,


School of International Health



Community and Global Health

Institute

Department

Personal name

Organization

N/A

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Uganda

Co-sponsor

NA

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2021

Year

06

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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