Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00519311




Registration number
NCT00519311
Ethics application status
Date submitted
21/08/2007
Date registered
22/08/2007
Date last updated
13/01/2017

Titles & IDs
Public title
Health Intervention for Adolescents With Intellectual Disability
Scientific title
RCT of an Intervention to Improve the Health of Adolescents With Intellectual Disability
Secondary ID [1] 0 0
401647
Universal Trial Number (UTN)
Trial acronym
Ask
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vision Impairment 0 0
Hearing Impairment 0 0
Obesity 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness
Mental Health 0 0 0 0
Learning disabilities
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Health Intervention Package

Experimental: School based health intervention - Educational intervention based on health diary + health check

No intervention: Usual care - Normal school curriculum and usual medical care


BEHAVIORAL: Health Intervention Package
CHAP and Ask Diary
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Level of health promotion
Timepoint [1] 0 0
Short term
Primary outcome [2] 0 0
Disease prevention
Timepoint [2] 0 0
Short term
Primary outcome [3] 0 0
Case finding activities (the identification of new disease)
Timepoint [3] 0 0
Short term
Primary outcome [4] 0 0
Acceptability and usefulness of both the CHAP health review and the ASK Diary
Timepoint [4] 0 0
Long term
Secondary outcome [1] 0 0
Appropriate health interventions
Timepoint [1] 0 0
Short term
Secondary outcome [2] 0 0
Ongoing maintenance of health care
Timepoint [2] 0 0
Long term

Eligibility
Key inclusion criteria
* Intellectual disability
* Aged >= 10 years
* Attend Special School or Units of Special Education in Southern Queensland
Minimum age
10 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* No intellectual disability
* Not aged >= 10 years
* Do not attend Special School or Unit of Special Education in Southern Queensland

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2010
Sample size
Target
Accrual to date
Final
732
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Queensland Centre for Intellectual and Developmental Disability, University of Queensland, Mater Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4101 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
People with intellectual disability die five to twenty years earlier than the general population. They also experience high levels of unrecognised disease and receive inadequate levels of health promotion or screening. Although they comprise 2.7% of our population (502 000 Australians) they receive scant, if any, attention in the health literature.

The barriers to good health for this population include: communication difficulties, impaired recall of significant health information, and inadequate training of health service providers. This project attempts to minimise some of these barriers through the use of a Health Intervention Package. Use of this package has been evaluated in adults, but not in adolescents, with intellectual disability.

The Health Intervention Package includes a comprehensive health review, called the Comprehensive Health Assessment Program (CHAP), which is performed by the adolescent's general practitioner, and a diary, the Ask diary, used to collect and store health information and to enhance health advocacy skills. We specifically aim to test if adolescents with intellectual disability using this package will receive better health screening and prevention (our primary outcomes). We also aim to test if using the package results in improved health advocacy by adolescents with intellectual disability and their parents (our secondary outcomes). The tool should also be acceptable to those involved (another secondary outcome). To investigate these aims we propose a clustered randomised controlled trial, a methodology we have used successfully in two previous trials. We will recruit 1000 adolescents (and their carers and teachers) in Special Education Schools and Special Education Units in Queensland.

The CHAP health review aims to produce shorter-term benefits of improved health screening/promotion and disease detection, such as increased sensory testing, identification of vision or hearing impairment, and improved immunisation rates. The Ask diary is intended to produce longer-term benefits such as improved communication about health matters, improved health advocacy skills, improved health record keeping, and increased health maintenance.
Trial website
https://clinicaltrials.gov/study/NCT00519311
Trial related presentations / publications
Lennox N, Ware R, Carrington S, O'Callaghan M, Williams G, McPherson L, Bain C. Ask: a health advocacy program for adolescents with an intellectual disability: a cluster randomised controlled trial. BMC Public Health. 2012 Sep 7;12:750. doi: 10.1186/1471-2458-12-750.
Doan T, Ware R, McPherson L, van Dooren K, Bain C, Carrington S, Einfeld S, Tonge B, Lennox N. Psychotropic medication use in adolescents with intellectual disability living in the community. Pharmacoepidemiol Drug Saf. 2014 Jan;23(1):69-76. doi: 10.1002/pds.3484. Epub 2013 Aug 8.
Carrington S., Lennox N., O'callaghan M., Mcpherson L. & Selva G. (2014) Promoting self-determination for better health and wellbeing for adolescents who have an intellectual disability. Australasian Journal of Special Education 38 (2), 93-114.
Lennox N, McPherson L, Bain C, O'Callaghan M, Carrington S, Ware RS. A health advocacy intervention for adolescents with intellectual disability: a cluster randomized controlled trial. Dev Med Child Neurol. 2016 Dec;58(12):1265-1272. doi: 10.1111/dmcn.13174. Epub 2016 Jun 25.
McPherson L, Ware RS, Carrington S, Lennox N. Enhancing Self-Determination in Health: Results of an RCT of the Ask Project, a School-Based Intervention for Adolescents with Intellectual Disability. J Appl Res Intellect Disabil. 2017 Mar;30(2):360-370. doi: 10.1111/jar.12247. Epub 2016 Feb 12.
Krause S, Ware R, McPherson L, Lennox N, O'Callaghan M. Obesity in adolescents with intellectual disability: Prevalence and associated characteristics. Obes Res Clin Pract. 2016 Sep-Oct;10(5):520-530. doi: 10.1016/j.orcp.2015.10.006. Epub 2015 Nov 11.
Patton KA, Ware R, McPherson L, Emerson E, Lennox N. Parent-Related Stress of Male and Female Carers of Adolescents with Intellectual Disabilities and Carers of Children within the General Population: A Cross-Sectional Comparison. J Appl Res Intellect Disabil. 2018 Jan;31(1):51-61. doi: 10.1111/jar.12292. Epub 2016 Oct 4.
Public notes

Contacts
Principal investigator
Name 0 0
Nicholas G Lennox, MBBS
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00519311