Evaluating the impact of a community-based intervention using womens groups (WG) to improve communication in Kenyan children with disabilities

ISRCTN	ISRCTN41075424
DOI	https://doi.org/10.1186/ISRCTN41075424
Secondary identifying numbers	N/A

Submission date: 10/07/2013
Registration date: 17/10/2013
Last edited: 23/10/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Charles Newton
Scientific

University of Oxford Dept of Psychiatry
Warneford Hospital
Oxford
OX37JX
United Kingdom

Study information

Study design	Cluster randomised trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant 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.
Scientific title	A cluster randomised trial educating womens groups (WG) to improve the communication and quality of life in Kenyan children with disabilities
Study objectives	Womens groups (WG) can improve the communication of children with disabilities by acting as agents of change.
Ethics approval(s)	Approved by the National Ethical Review Committee of Kenya on 7th March 2002 (KEMRI Scientific Steering Committee No 673)
Health condition(s) or problem(s) studied	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
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 study start date	01/07/2002
Completion date	20/12/2003

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Years
Upper age limit	9 Years
Sex	Both
Target number of participants	306 children
Key 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.
Key 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
Date of first enrolment	01/07/2002
Date of final enrolment	20/12/2003

Locations

Countries of recruitment

England
Kenya
United Kingdom

Study participating centre

University of Oxford Dept of Psychiatry

Oxford
OX37JX
United Kingdom

Sponsor information

University of East Anglia (UK)
University/education

School of Rehabilitation
Norwich Research Park
Norwich
NR4 7TJ
England
United Kingdom

Website	http://www.uea.ac.uk
"ROR"	https://ror.org/026k5mg93

Funders

Funder type

Charity

Department for International Development (DFID) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

23/10/2019: No publications found, verifying study status with principal investigator.

Evaluating the impact of a community-based intervention using womens groups (WG) to improve communication in Kenyan children with disabilities