Condition category
Not Applicable
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
02/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes