Contact information
Type
Scientific
Primary contact
Dr Shiela Puri
ORCID ID
Contact details
Child Development Centre
Beckett Street
Leeds
LS9 7TF
United Kingdom
-
sheila.puri@leedsth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436176307
Study information
Scientific title
Does an integrated needs assessment (INA) identify the health social and educational needs of young people with complex disabilities and facilitate better health outcomes and social adjustment at the time of transition to adulthood?
Acronym
Study hypothesis
To determine whether an integrated needs assessment is an appropriate tool in young people with complex disabilities that will:
1. Identify health and social needs met and unmet
2. Facilitate a smooth transition between children and adult services
3. Assist young people and their families to maximise their opportunities for social integration education employment and access to health care following transition into adult services
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Social and educational needs of young people with complex disabilities
Intervention
Integrated needs assessment vs no integrated needs assessment
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The end point for participants will be one year after the initial recruitment after completion of validated outcome questionnaires. The outcomes that will be measured are the health status of the young person the well being and stress level for the young person and their families. This will be done using the following validated questionnaires:
1. Euroqol part 1
2. London Handicap Scale
3. Nottingham Health Profile
4. Bartell Scale
5. Cohen's Perceived Stress Scale
6. Beck's hopelessness scale
7. Adult well being scale (Department of Health, UK)
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/2006
Overall trial end date
01/02/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
The population group will be from Leeds. We intend to recruit 84 young people and their families for the study. There will be equal numbers in the intervention group and the control group.
Educational authorities in Leeds, Education Leeds, keep a record of all young people with complex needs and that are potential school leavers (approx 150 per year).
The participants will be drawn up from these lists.
Permission will be taken from Education Leeds and we will comply with the data protection act to contact these families. In majority of the cases families would have agreed to share information with school health services as good practice states that all children with special needs should have joint care planning.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
84
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/02/2006
Recruitment end date
01/02/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Child Development Centre
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Leeds Teaching Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
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