Plain English Summary
Background and study aims
Studies suggest that over 40% of children with disabilities in resource-poor countries have a communication disability. This forms one of the largest sub-groups of disablement, an estimated 2.5% of a total population. Services and support for this population group are almost non-existent in these settings. This study evaluates the impact of a community-based intervention by womens groups (WG), to improve communication and quality of life. The intervention has been developed through a participatory process with WG in Kenya, and also draws on information collected in Uganda and Zimbabwe. The aim is to improve the communication skills and quality of life of children with communication disabilities.
Who can participate?
Active WGs in Kilifi, Kenya will be identified, in an area where a neurological survey has identified children (aged 6-9 years) with communication impairment.
What does the study involve?
These WG will be randomly allocated to one of two groups: an intervention to promote communication in children with disabilities or no intervention at all. The study interacted with existing womens groups and developed skills and awareness about how they could improve the communication skills and quality of life of children with communication disabilities in their community. The intervention encouraged and facilitated participation in everyday activities, sensitised the community, and promoted attendance at school.
What are the possible benefits and risks of participating?
The risk to participants was limited to issues of confidentiality about their impairment status. The successful aspects of the intervention will be identified and used to suggest future interventions and research studies. If the strategy of using WG as agents of change is successful, it can be used as part of Community-based Rehabilitation strategies in other areas of Kenya and in other African countries.
Where is the study run from?
There was only one centre which is the Centre for Geographical Medicine (Coast), Kilifi Kenya.
When is study starting and how long is it expected to run for?
The study took place between 2002 and 2003, with 9 months to deliver the intervention.
Who is funding the study?
The project was funded by the Department for International Development and the Wellcome Trust (UK).
Who is the main contact?
Professor Charles Newton
charles.newton@psych.ox.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A cluster randomised trial educating womens groups (WG) to improve the communication and quality of life in Kenyan children with disabilities
Acronym
Study hypothesis
Womens groups (WG) can improve the communication of children with disabilities by acting as agents of change.
Ethics approval
Approved by the National Ethical Review Committee of Kenya on 7th March 2002 (KEMRI Scientific Steering Committee No 673)
Study design
Cluster randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request information given to the women's groups and patients and their families.
Condition
Communication impairment; Disabilities
Intervention
Random selection of 8 Women's Groups (out of 50 in the area) to participate in the training & intervention & cover 50% of children who had been identified with a communication problem.
These WG will be randomised to receive an intervention to promote communication in children with disabilities, or no intervention at all.
An intervention will be carried out with women from local womens groups (WG) aimed at promoting the development of communication ability through the introduction of simple strategies. These strategies include:
1. Raising awareness concerning communication disabilities
2. Raising awareness to their potential role in supporting this group of children and their families
3. Inclusion of children with communication disability in everyday activities.
4. Respite strategies for carers
5. Increased opportunity for experiences and communication
Intervention was completed at 9 months. The total duration was 12 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Improved communication as measured by the Communication Disability Profile, which uses a multi-dimensional theoretical framework, reflecting the new WHO classifications of disablement and a communication disability model based on identification of needs.
Measurements were taken at baseline and at 12 months. Intervention was completed at 9 months.
Secondary outcome measures
Quality of life (QOL) as measured by a locally developed tool, which was based on qualitative data collected from the same 16 Mothers and community groups and the QOL measurement tool for assessing adults in developing countries was also used to inform the development of this questionnaire.
Measurements were taken at baseline and at 12 months. Intervention was completed at 9 months.
Overall trial start date
01/07/2002
Overall trial end date
20/12/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women's groups (WG) who work in an area in whom children aged 6-9 years of age were identified with communication impairment. The WG had to agree to participate.
2. The parents of the children identified with communication impairment gave consent and the the children who reside in the areas where the active WG are located.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
306 children
Participant exclusion criteria
1. Women's groups (WG) not active
2. Children whose parents refuse consent
3. Children whose parents give a negative response to the identification questions.
4. Children who do not reside in the area where the active WG are located
Recruitment start date
01/07/2002
Recruitment end date
20/12/2003
Locations
Countries of recruitment
Kenya
Trial participating centre
University of Oxford Dept of Psychiatry
Oxford
OX37JX
United Kingdom
Sponsor information
Organisation
University of East Anglia (UK)
Sponsor details
School of Rehabilitation
Norwich Research Park
Norwich
NR4 7TJ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Department for International Development (DFID) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list