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Trial registered on ANZCTR


Registration number
ACTRN12619001750178
Ethics application status
Approved
Date submitted
16/10/2019
Date registered
10/12/2019
Date last updated
10/12/2019
Date data sharing statement initially provided
10/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Supporting Ultra Poor People with Rehabilitation and Therapy - an open label trial among families of children with Cerebral Palsy in rural Bangladesh (SUPPORT CP Trial)
Scientific title
Supporting Ultra Poor People with Rehabilitation and Therapy - an open label trial among families of children with Cerebral Palsy in rural Bangladesh (SUPPORT CP Trial)
Secondary ID [1] 298008 0
None
Universal Trial Number (UTN)
None
Trial acronym
SUPPORT CP (Supporting Ultra Poor People with Rehabilitation and Therapy Cerebral Palsy)

Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 312813 0
Anxiety 312814 0
Depression 315422 0
Condition category
Condition code
Neurological 311308 311308 0 0
Other neurological disorders
Mental Health 311309 311309 0 0
Anxiety
Mental Health 311310 311310 0 0
Depression
Neurological 311311 311311 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will have three arms; two intervention arms and one control arm.
The first intervention arm is an integrated microfinance/livelihood and Community-Based Rehabilitation (IMCBR). IMCBR has been developed based on findings from the literature and pilot data from the Bangladesh CP Register study, and subsequent survey on microfinance activities among BCPR registrants.
IMCBR has two components:
1. Microfinance/livelihood program:
Duration of intervention: One-off Microfinance/livelihood support with fortnightly follow-up for 12 months
Microfinance would be provided to the families of children with CP for purchasing livelihoods (e.g., livestock - chicken, goats). This will assist the families for increasing the income of the family. Participants randomized to IMCBR will be supported to create each microfinance cluster/group (~10 families of children with CP in each group). The groups will be formed voluntarily along geographical boundaries to facilitate participation, retention, and meeting logistics. Each cluster will be visited weekly to discuss livelihood activities (e.g. progress, troubleshooting) (90 minutes), and for community-based rehabilitation (CBR) for children with CP comprising early intervention and primary caregiver's education (90 minutes). The cluster meetings, including CBR activities, will be facilitated by specially trained Community Rehabilitation Officers (CRO). CROs will receive training in microfinance as well as basic physiotherapy and CBR.
A group meeting will be organised with members of each cluster to discuss (i) details of the program, (ii) benefit from the program and (iii) motivation for participation.
2. Community-based rehabilitation (CBR):
There will be two major elements of the CBR program, which will occur simultaneously during cluster meetings following the microfinance/livelihood portion.
a. Goal Directed Training (GDT)-
Duration of intervention: Once a week for three hours for 12 months
Community-based GDT focused on motor learning will be conducted among the children with CP and their primary caregiver. GDT will be delivered by child’s primary caregiver (participating parent). Sessions will be facilitated by the CROs with the aim that primary caregiver will continue to deliver GDT independently at home.
GDT is an activity-based approach to therapy. Meaningful, client-selected goals are used to provide opportunities for problem-solving and to indirectly drive the movements required to successfully meet task demands. A meta-analysis of effective interventions for children with CP has shown that GDT based interventions are highly effective and should be the gold standard treatment for CP.
Activities taught: There will be four activities taught in GDT-
(1) Goal selection: The community-based rehabilitation session will start with realistic and appropriately time-framed goals set up in collaboration with parents. Goals are basically some specific tasks that are needed for everyday life and which children with CP find challenging. These tasks could be a gross motor function (e.g. sitting), self-care (e.g. eating), communication (e.g. asking for something verbally, using gesture), play or school-based activities.
(2) Assessment: A detailed assessment will then be carried out to identify the facilitating factors in achieving the goals. This will involve assessing the physical requirements of the selected task (e.g. balance for sitting) and the requirements of resources and equipment (e.g. activities-specific toys) and the settings (e.g. place of assessment).
(3) Intervention: The Community Rehabilitation Officer (CRO) will scaffold the selected motor tasks, so that the child could actively complete at least a part of the task. Parents will be encouraged to use their knowledge of their child’s play preferences to elicit self-generated motor activity. Modified constraint-induced movement therapy(mCIMT) and/or bimanual training will be used when asymmetrical hand function is evident (e.g. Hemiplegia). CROs will also teach parents how to set up a motor-enriched play environment at home to promote child’s self-generated movements, exploration and task success. Parents will be advised to practice until the main goal is achieved.
(4) Outcome evaluation: The primary caregiver will be taught how to monitor and evaluate the extent to which a child’s goals are achieved.

b. Parents Training Module (PTM)
Duration: Three hours weekly for 12 months
In the training sessions of GDT Primary caregivers will be taught to provide training to the children CP. participate in PTM to learn basic therapeutically-correct skills for the day-to-day care and support of their child with CP embedded in the principles of GDT. The program will follow the PTM ‘Getting to know cerebral palsy’ and includes 10 modules by which primary caregivers/parents will be trained and made aware regarding the management of children with CP at home including delivering GDT.
These modules include: What is Cerebral Palsy, Evaluating Your Child, Positioning and Carrying, Communication, Everyday Activities, Feeding Your Child, Play, Disability in Your Local Community, Running Your Own Parent Support Group and Assistive Devices and Resources.

In the second arm, only CBR will be delivered (not the microfinance/livelihood components of IMCBR)

Intervention code [1] 314450 0
Rehabilitation
Comparator / control treatment
The control group is formed as "no intervention" or "care as usual".
This group will not receive any study intervention for the study. The children with CP of this group will take treatment through the usual care route, which typically includes treatment in govt. hospitals.


Control group
Active

Outcomes
Primary outcome [1] 320045 0
Health-related quality of life (HRQoL) of Child with CP ;

The health-related quality of life (HRQoL) of children with CP will be assessed using TNO-AZL Preschool Children’s Quality of Life questionnaire (TAPQOL). TAPQOL is a standard and validated tool to measures parent’s perceptions of Health-related quality of life in preschool children. The questionnaire was developed for children between 9 months and 6 years (5 years and 12 months) old. Data will be collected by interviewing the primary caregivers of the children with CP through TAPQOL. It takes approximately 10 minutes to fill in the questionnaire.
The TAPQOL is a multidimensional instrument which includes three different dimensions: physical functioning, social functioning, cognitive functioning through 43 different items of 12 scales. The domains covered by the TAPQOL are based on a review of the literature, discussions with experts (child psychologists, pediatricians, and parents) and statistical testing.
Timepoint [1] 320045 0
At baseline (pre-enrolment) and at 12 months post-enrolment.
Secondary outcome [1] 370353 0
Peabody Developmental Motor Scale (PDMS II) scores .
Timepoint [1] 370353 0
At baseline (pre-enrolment) and at 12 months post-enrolment.
Secondary outcome [2] 377471 0
Gross Motor Function Measure (GMFM).
Timepoint [2] 377471 0
At baseline (pre-enrolment) and at 12 months post-enrolment.
Secondary outcome [3] 377472 0
Cognitive Function Classification System
Timepoint [3] 377472 0
At baseline (pre-enrolment) and at 12 months post-enrolement.
Secondary outcome [4] 377473 0
Nutritional status of the children with CP (WHO standardised z scores);
Nutritional status will be based on the selected standard anthropometric measurement. These include;
(i) Weight: Weight will be measured in kilogram using digital weighing scale with 10 gram precision. Tared weight will be measured for children who cannot stand independently. Three repeated measures will be taken. Average weight will be recorded.
(ii) Length/Height: Length/Height will be measured in centimetre (cm) using length/height board with a precision of 1 cm. Length will be measured for children aged less than 24 months, height will be measured for children aged 24-60 months. For children who could not stand independently, knee height will be measured and supine length will be measured using following formula; height= (2.69 × knee height) +24.2. [1] Three repeated measures (length/height/knee height) will be taken and average value will be recorded.

Reference:
1. Stevenson RD. Use of segmental measures to estimate stature in children with cerebral palsy. Arch Pediatr Adolesc Med. 1995;149(6):658–662.

(iii) Mid-upper arm circumference (MUAC): MUAC will be measured in centimeter (cm) using MUAC tape with a precision of 0.1 cm.
(iv) Skin-fold thickness: Bicep, triceps and subscapular skin-fold thickness will be measured in millimetre. Three repeated measures will be taken, and the average will be noted.
(v) Head-circumference: Head circumference will be measured in centimeter (cm) with a precision of 1 cm.

Z scores for all measurement (i-v) will be calculated and World Health Organization (WHO) cut-off will be used to categorize nutritional status of children with CP.
Timepoint [4] 377473 0
At baseline (pre-enrolment) and at 12 months post-enrolement.
Secondary outcome [5] 377474 0
Depression, Anxiety, Stress Scale – Short Form (DASS 21), a self-reported norm-referenced measure of depression, anxiety and stress.
Timepoint [5] 377474 0
At baseline (pre-enrolment) and at 12 months post-enrolement.
Secondary outcome [6] 377475 0
Family income;
Two approaches will be taken to measure the economic status of the families of children with CP.
(i) Caregiver reported monthly family income and monthly family expenditure will be documented.
(ii) We will adopt a subset of the questionnaire for Bangladesh Demographic and Health Survey (BDHS) to measure household wealth index of the participants. BDHS is a nationwide survey conducted in every four years by Government of Bangladesh in collaboration with National Institute of Population Research and Training (NIPORT), Mitra and Associates and USAID.
Timepoint [6] 377475 0
At baseline (pre-enrolment) and at 12 months post-enrolement.
Secondary outcome [7] 377476 0
Social capital;

Bangla version of “Short version of the Adapted Social Capital Assessment Tool (SASCAT)” will be used to measure social capital of the primary caregivers of children with CP in our study. The tool was developed by Silva et al. based on another detailed tool previously developed by World Bank. The tool was later modified as part of Young Lives (YL) research project conducted in 2002 in Ethiopia, Vietnam, Peru and India and was used to measure social capital of caregivers of children aged 1-8 years. In 2012, the tool was translated into Bangla language and validated by Story et al. in Bangladesh. [1,2]

The SASCAT tool measures (i) structural social capital and (ii) cognitive social capital. The structural social capital is assessed based on responses on following four domains (a) group membership, (b) support from groups, (c) support from individuals, and (d) collective action. The cognitive social capital is assessed on following two domains; (a) trust and (b) social cohesion.

References
1. De Silva MJ, Harpham T, Tuan T, Bartolini R, Penny ME, Huttly SR. Psychometric and cognitive validation of a social capital measurement tool in Peru and Vietnam. Social Science & Medicine. 2006 Feb 1;62(4):941-53.
2. Story WT, Taleb F, Ahasan SM, Ali NA. Validating the measurement of social capital in Bangladesh: A cognitive approach. Qualitative health research. 2015 Jun;25(6):806-19.
Timepoint [7] 377476 0
At baseline (pre-enrolment) and at 12 months post-enrolement.

Eligibility
Key inclusion criteria
1. Diagnosis of CP according to Surveillance of CP in Europe (SCPE) and Australian CP Register (ACPR) guidelines(recorded in BCPR).
2. Participant-pairs constituting a primary caregiver of a child with CP, and a child with CP aged 5 years and below.
3. Participant-pairs are classified as ultra-poor (i.e. total family income less than 1.25 USD per day).
3. Capacity to give informed consent and willing to take part in the study including microfinance arm along with their child with CP.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Currently in receipt of microfinance/livelhood from any other source
2. Currently participating in any other clinical trial or intervention program

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Open-label; arms will not be selected randomly rather conveniently selected. However, participants will be selected randomly in each arm.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Intention-to-treat analysis will compare improvements in primary and other outcomes between groups controlling for baseline measures. Descriptive statistics (frequencies, means and 95% confidence intervals) will be used to describe the sample at baseline and post-intervention. Hypothesis testing will be done using appropriate statistical procedures based on the type of data. For example, a Chi-square test will be used to measure the statistical difference between proportions of outcome among study arms. Baseline characteristics will be compared and adjusted using appropriate regression models. All analyses will be conducted using STATA 15, with the significance level set at p<0.05. Data manipulation and visualization will be done using R studio/GraphPad Prism 7.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21468 0
Bangladesh
State/province [1] 21468 0
Shahjadpur, Serajganj, Rajshahi

Funding & Sponsors
Funding source category [1] 302532 0
Charities/Societies/Foundations
Name [1] 302532 0
Cerebral Palsy Alliance
Address [1] 302532 0
Cerebral Palsy Alliance Research Foundation
187 Allambie Rd, Allambie Heights, NSW 2100
PO Box 6427, Frenchs Forest, NSW 2086
Country [1] 302532 0
Australia
Primary sponsor type
Other Collaborative groups
Name
CSF Global
Address
Flat B3, House 9
Road 2/1, Banani R/A
Dhaka Dhaka 1213
Country
Bangladesh
Secondary sponsor category [1] 302692 0
None
Name [1] 302692 0
None
Address [1] 302692 0
None
Country [1] 302692 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303181 0
Bangladesh Medical Research Council (BMRC)
Ethics committee address [1] 303181 0
Bangladesh Medical Research Council (BMRC)
BMRC Bhaban, Mohakhali, Dhaka-1212, Bangladesh
Phone: +880 2 9848396, +880 9849311(PABX)
Fax: +880-2-9848820
Email: info@bmrcbd.org
Ethics committee country [1] 303181 0
Bangladesh
Date submitted for ethics approval [1] 303181 0
30/06/2019
Approval date [1] 303181 0
09/10/2019
Ethics approval number [1] 303181 0
BMRC/NREC/2016-2019/251

Summary
Brief summary
Bangladesh Cerebral Palsy (CP) Register research findings confirm that poverty is a key contributor to late diagnosis and limited access to early intervention and rehabilitation for children with CP in rural Bangladesh. 97% of families of children with CP live below the poverty line. Therefore, in low and middle-income countries, efforts to improve outcomes for children with CP (including quality of life, motor, cognitive and nutritional attainments) should also include measures to improve family economic/social capital. We propose an open-label pragmatic trial to evaluate the effectiveness of an integrated microfinance/livelihood and community-based rehabilitation (IMCBR) program for ultra-poor families of children with CP in rural Bangladesh. We hypothesize that IMCBR will facilitate improved access to capital leading to better income and thus increase the family’s investment in physical health overall. Moreover, community-based rehabilitation will provide an opportunity for sharing ideas, information, and developing important non-cognitive skills, such as self-confidence of primary caregivers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92770 0
Prof Gulam Khandaker
Address 92770 0
Central Queensland Public Health Unit
Rural and District Wide Services | Central Queensland Hospital and Health Service | Queensland Government | 82-86 Bolsover Street Rockhampton QLD 4700

Country 92770 0
Australia
Phone 92770 0
+610749206948
Fax 92770 0
Email 92770 0
gulam.khandaker@health.nsw.gov.au
Contact person for public queries
Name 92771 0
Prof Gulam Khandaker
Address 92771 0
Central Queensland Public Health Unit
Rural and District Wide Services | Central Queensland Hospital and Health Service | Queensland Government | 82-86 Bolsover Street Rockhampton QLD 4700

Country 92771 0
Australia
Phone 92771 0
+610749206948
Fax 92771 0
Email 92771 0
gulam.khandaker@health.nsw.gov.au
Contact person for scientific queries
Name 92772 0
Prof Gulam Khandaker
Address 92772 0
Central Queensland Public Health Unit
Rural and District Wide Services | Central Queensland Hospital and Health Service | Queensland Government | 82-86 Bolsover Street Rockhampton QLD 4700
Country 92772 0
Australia
Phone 92772 0
+61 07 4920 6948
Fax 92772 0
Email 92772 0
gulam.khandaker@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will not share any participant data
What supporting documents are/will be available?
No other documents available
Summary results
No Results