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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00519311
Other study ID # 401647
Secondary ID
Status Completed
Phase N/A
First received August 21, 2007
Last updated January 11, 2017
Start date January 2006
Est. completion date June 2010

Study information

Verified date May 2015
Source The University of Queensland
Contact n/a
Is FDA regulated No
Health authority Australia: National Health and Medical Research Council
Study type Interventional

Clinical Trial 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.


Description:

The intervention group of school adolescents will receive the Health Intervention Package (consisting of an Ask diary and a CHAP health review). During the first two terms of school the adolescents will receive their own Ask diary and will be trained in the use of the diary by their teacher. At the end of term two the carers and adolescents will be asked to complete part one of the CHAP tool, which comprises a health history, and make an appointed with their GP to complete a health assessment. After this assessment both the adolescent and the parent will use the Ask diary for all ongoing healthcare matters. The control group will receive their customary educational and medical care.


Recruitment information / eligibility

Status Completed
Enrollment 732
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 20 Years
Eligibility Inclusion Criteria:

- Intellectual disability

- Aged >= 10 years

- Attend Special School or Units of Special Education in Southern Queensland

Exclusion Criteria:

- No intellectual disability

- Not aged >= 10 years

- Do not attend Special School or Unit of Special Education in Southern Queensland

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Intervention

Behavioral:
Health Intervention Package
CHAP and Ask Diary

Locations

Country Name City State
Australia Queensland Centre for Intellectual and Developmental Disability, University of Queensland, Mater Hospital Brisbane Queensland

Sponsors (2)

Lead Sponsor Collaborator
The University of Queensland National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

References & Publications (7)

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.

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/ — View Citation

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. — View Citation

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.131 — View Citation

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. — View Citation

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. 2016 Feb 12. doi: 10.1111/j — View Citation

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 Dis — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Level of health promotion Short term No
Primary Disease prevention Short term No
Primary Case finding activities (the identification of new disease) Short term No
Primary Acceptability and usefulness of both the CHAP health review and the ASK Diary Long term No
Secondary Appropriate health interventions Short term No
Secondary Ongoing maintenance of health care Long term No
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