NCT00519311

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
732

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

January 13, 2017

Status Verified

May 1, 2015

Enrollment Period

4.4 years

First QC Date

August 21, 2007

Last Update Submit

January 11, 2017

Conditions

Keywords

Intellectual disabilityHealth promotionRCT

Outcome Measures

Primary Outcomes (4)

  • Level of health promotion

    Short term

  • Disease prevention

    Short term

  • Case finding activities (the identification of new disease)

    Short term

  • Acceptability and usefulness of both the CHAP health review and the ASK Diary

    Long term

Secondary Outcomes (2)

  • Appropriate health interventions

    Short term

  • Ongoing maintenance of health care

    Long term

Study Arms (2)

School based health intervention

EXPERIMENTAL

Educational intervention based on health diary + health check

Behavioral: Health Intervention Package

Usual care

NO INTERVENTION

Normal school curriculum and usual medical care

Interventions

CHAP and Ask Diary

School based health intervention

Eligibility Criteria

Age10 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Intellectual disability
  • Aged \>= 10 years
  • Attend Special School or Units of Special Education in Southern Queensland

You may not qualify if:

  • No intellectual disability
  • Not aged \>= 10 years
  • Do not attend Special School or Unit of Special Education in Southern Queensland

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queensland Centre for Intellectual and Developmental Disability, University of Queensland, Mater Hospital

Brisbane, Queensland, 4101, Australia

Location

Related Publications (7)

  • 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.

    PMID: 22958354BACKGROUND
  • 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.

    RESULT
  • 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.

MeSH Terms

Conditions

Vision DisordersHearing LossObesityIntellectual Disability

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightNeurobehavioral ManifestationsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Nicholas G Lennox, MBBS

    The University of Queensland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Investigator

Study Record Dates

First Submitted

August 21, 2007

First Posted

August 22, 2007

Study Start

January 1, 2006

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

January 13, 2017

Record last verified: 2015-05

Locations