Health Intervention for Adolescents With Intellectual Disability (Ask)

January 11, 2017 updated by: Nicholas Lennox, The University of Queensland

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

732

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Queensland Centre for Intellectual and Developmental Disability, University of Queensland, Mater Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: School based health intervention
Educational intervention based on health diary + health check
Behavioral: Health Intervention Package
CHAP and Ask Diary
No Intervention: Usual care
Normal school curriculum and usual medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of health promotion
Time Frame: Short term
Short term
Disease prevention
Time Frame: Short term
Short term
Case finding activities (the identification of new disease)
Time Frame: Short term
Short term
Acceptability and usefulness of both the CHAP health review and the ASK Diary
Time Frame: Long term
Long term

Secondary Outcome Measures

Outcome Measure
Time Frame
Appropriate health interventions
Time Frame: Short term
Short term
Ongoing maintenance of health care
Time Frame: Long term
Long term

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Queensland

Collaborators

National Health and Medical Research Council, Australia

Investigators

  • Principal Investigator: Nicholas G Lennox, MBBS, The University of Queensland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

August 21, 2007

First Submitted That Met QC Criteria

August 21, 2007

First Posted (Estimate)

August 22, 2007

Study Record Updates

Last Update Posted (Estimate)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 401647

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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