Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Shiela Puri


Contact details

St James's University Hospital
Beckett Street
United Kingdom
+44 (0)113 206 4591

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Is an integrated needs assessment a useful tool to identify needs and facilitate transition from children to adult services?


Study hypothesis

Is an integrated needs assessment a useful tool to identify needs and facilitate transition from children to adult services?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design


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


Young Children with Complex Neurodevelopmental and Health Needs


The young people and their carers will be provided with an information leaflet explaining the purpose and the design of the project and will be given the opportunity to ask questions. Participants will be randomised into 1 of 2 groups.
Group 1 = Control: the control group will continue to have their routine management, including a transition plan, if appropriate, co-ordinated through their educational establishment.
Group 2 = Intervention: In addition, the Intervention group will have an integrated needs assessment, co-ordinated by the principal investigator. After 1 year of the transition plan, a follow up interview with both groups will take place and questionnaires will be used.

The relevant health professionals, educational staff and colleagues within social services within Leeds have been made aware of the research project through established meetings. The parents/carers with parental responsibility will be asked to give consent on behalf of the young person if they are unable to do so. Confidential and secure filing systems. A copy of the needs assessment will be given to the participants and all relevant agencies, with the appropriate consent from the participant and their carers. The collating of the information from all professionals and agencies involved in the patients care forms a crucial sharing of the information. During the presentation of the research the names of the participants will be anonymous.

Intervention type



Not Specified

Drug names

Primary outcome measures

To determine whether an Integrated Needs Assessment is an appropriate tool in young people with complex disabilities that will:
1. Identify their health and social needs met and unmet
2. Identify any gaps in the service provision during the period of transition
3. Facilitate smooth transition between children and adult services
4. 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

Secondary outcome measures

1. To evaluate the quality of life/anxiety and stress levels in the young person and carer at the time of transition from paediatric services to adult services.
2. To ascertain how long it takes to undertake the assessment.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Approx 84 young people (aged between 16-19 and who are potential school leavers) and their families will be recruited through data stored by Education Leeds.
2. Young people from all racial and ethnic backgrounds will be included.
3. Both males and females will be included.
4. Sexual orientation will not be enquired about as this is not an exclusion criteria.

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Young people who have already had an integrated needs assessment in the last three years (as this will confound the results) 2. Young people who are currently residing full time in a residential home, run by social services (as we would not be able to obtain a true picture of the needs of the carer and the young person may not have a single allocated carer to provide us with the needs of the person)
3. Young people who are terminally ill will also be excluded from this group.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

St James's University Hospital
United Kingdom

Sponsor information


Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
United Kingdom
+44 (0)207 307 2622

Sponsor type




Funder type

Hospital/treatment centre

Funder name

Bradford South and West Primary Care Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype


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