Condition category
Mental and Behavioural Disorders
Date applied
10/07/2013
Date assigned
17/10/2013
Last edited
17/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 women’s 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 women’s 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

Contact information

Type

Scientific

Primary contact

Dr Charles Newton

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A cluster randomised trial educating women’s groups (WG) to improve the communication and quality of life in Kenyan children with disabilities

Acronym

Study hypothesis

Women’s 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 women’s 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 measures

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

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

http://www.uea.ac.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes