Vision ImpairmentAskNCT00519311
Health Intervention for Adolescents With Intellectual Disability
A study testing Health Intervention Package in people with Vision Impairment and Hearing Impairment, run by The University of Queensland at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 10 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Vision Impairment, Hearing Impairment, Obesity
- What is being tested?
- Health Intervention Package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 732 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2006to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Intellectual disability
- Aged >= 10 years
- Attend Special School or Units of Special Education in Southern Queensland
Who cannot join
- No intellectual disability
- Not aged >= 10 years
- Do not attend Special School or Unit of Special Education in Southern Queensland
Trial locations and contacts
1 site in 1 country.
Australia1 site
Queensland Centre for Intellectual and Developmental Disability, University of Queensland, Mater Hospital
Brisbane, Queensland, 4101
About this study
Official title: RCT of an Intervention to Improve the Health of Adolescents With Intellectual Disability
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.
Read more
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.
Read the detailed 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.
- Conditions
- Vision Impairment, Hearing Impairment, Obesity
- Being tested
- Health Intervention Package
- Keywords
- Intellectual disability, Health promotion, RCT
- Medical subject headings
- Vision Disorders, Hearing Loss, Obesity, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Intervention PackageBehavioural
CHAP and Ask Diary
| Study group | Role | What they receive |
|---|---|---|
| School based health intervention | Experimental | Educational intervention based on health diary + health check Receives: Behavioral: Health Intervention Package |
| Usual care | No intervention | Normal school curriculum and usual medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of health promotion
Measured: Short term
Disease prevention
Measured: Short term
Case finding activities (the identification of new disease)
Measured: Short term
Acceptability and usefulness of both the CHAP health review and the ASK Diary
Measured: Long term
Secondary outcomes (2)
Appropriate health interventions
Measured: Short term
Ongoing maintenance of health care
Measured: Long term
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2007 (estimated)
- Study startJan 2006
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Vision ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 732 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Responsible party
- Principal investigator, Nicholas Lennox, The University of Queensland
- Investigators
- Nicholas G Lennox, MBBS, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519311
- Sponsor's protocol ID
- 401647
- Acronym
- Ask
- Status last verified
- May 2015
- First submitted
- 21 Aug 2007
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22958354Doan 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.
PubMed 23929635Carrington 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.
PubMed 27343021McPherson 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.
PubMed 26868513Krause 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.
PubMed 26559898Patton 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.
PubMed 27704663
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of an Intervention to Improve the Health of Adolescents With Intellectual Disability
- ClinicalTrials.gov ID
- NCT00519311
- Acronym / sponsor ID
- Ask / 401647
- Conditions
- Vision Impairment, Hearing Impairment, Obesity
- Keywords
- Intellectual disability, Health promotion, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 732 participants (actual)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- Jan 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 22 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| School based health intervention | Experimental | Behavioral: Health Intervention PackageEducational intervention based on health diary + health check |
| Usual care | No intervention | –Normal school curriculum and usual medical care |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Intellectual disability
- Aged >= 10 years
- Attend Special School or Units of Special Education in Southern Queensland
Key exclusion criteria (3 listed)
- No intellectual disability
- Not aged >= 10 years
- Do not attend Special School or Unit of Special Education in Southern Queensland
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Intervention PackageCHAP and Ask Diary | Behavioural | School based health intervention |
Primary outcome
Level of health promotion
Time frame: Short term
Disease prevention
Time frame: Short term
Case finding activities (the identification of new disease)
Time frame: Short term
Acceptability and usefulness of both the CHAP health review and the ASK Diary
Time frame: Long term
2 secondary outcomes
Appropriate health interventions
Time frame: Short term
Ongoing maintenance of health care
Time frame: Long term
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
- Background: PubMed 22958354Lennox 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.
- Results publication: PubMed 23929635Doan 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.
- Results publicationCarrington 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.
- Results publication: PubMed 27343021Lennox 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.
- Results publication: PubMed 26868513McPherson 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.
- Results publication: PubMed 26559898Krause 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.
- Results publication: PubMed 27704663Patton 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.
Related trials for Vision Impairment
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Not yet recruiting
NEURO-COGS: Neurometabolic Mechanisms of Cognitive Training in Schizophrenia
Schizophrenia, Schizoaffective Disorder
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO
Diabetic Macular Edema (DME)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas G Lennox, MBBS principal investigator
The University of Queensland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Intervention Package in people with Vision Impairment and Hearing Impairment, run by The University of Queensland at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of health promotion (time frame: Short term). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00519311, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.