Plain English Summary
Background and study aims
Students begin experimenting with tobacco and alcohol between 11 and 15 years of age. However, there are no data for 11–15-year-old students with intellectual disabilities. Prevention programmes, like Prepared on time, are successful, but their efficacy has not been studied in students with intellectual disabilities. Prepared on time, based on the ASE model, can be used in the fifth and sixth grades of primary schools. The aim in this study is to examine the tobacco and alcohol use among first and second grade students in special needs secondary schools and to undertake a preliminary study to test the e-learning programme in this population.
Who can participate?
Adolescents with intellectual disabilities
What does the study involve?
Five schools will be randomly assigned to two groups, experimental or control. In the first week, children in both the experimental and control groups will be asked to complete a questionnaire. Two weeks after completing the first questionnaire, participants in the experimental group will be enrolled in the programme. Three weeks after working with the programme, both groups will complete a follow-up questionnaire.
What are the possible benefits and risks of participating?
There are no known benefits or risks to participants taking part in this study.
Where is the study run from?
Five special education schools in the Netherlands: OSG Erasmus – Praktijkonderwijs, Bonhoeffer Praktijk Locatie Vlierstraat, Thomas a Kempis College, Praktijkonderwijs Zutphen and De Maat Ommen.
When is the study starting and how long is it expected to run for?
From January 2010 to January 2011
Who is funding the study?
Aveleijn Intellectual Disabilities Services (Netherlands)
Who is the main contact?
Ms Marion Kiewik
Trial website
Contact information
Type
Scientific
Primary contact
Dr Cor de Jong
ORCID ID
http://orcid.org/0000-0002-2802-6910
Contact details
Radboud Universiteit Nijmegen/ACSW
NISPA
Postbus 6909
Nijmegen
6503 GK
Netherlands
Type
Public
Additional contact
Ms Marion Kiewik
ORCID ID
Contact details
Grotestraat 260
Borne
7622 GW
Netherlands
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Substance use prevention programme in special education schools: a cluster randomised control trial
Acronym
Study hypothesis
1. We assume a high lifetime prevalence of tobacco and alcohol use among adolescents with intellectual disabilities in the Netherlands.
2. We assume that the programme Prepared on time will increase smoking and drinking knowledge of students with intellectual disabilities. Furthermore, we assume that Prepared on time will influence behavioural determinants, based on the attitude-social influence-efficacy (ASE) model. This programme was originally used in the fifth and sixth grades of primary schools.
Ethics approval
Boards of the participating schools; approval date and reference not provided at time of registration
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Condition
Adolescents with mild intellectual disabilities, attending special secondary needs schools
Intervention
1. This study is a cluster randomised controlled trial among 210 students with a borderline or mild intellectual disabilities to avoid contamination between classes
2. An invitation letter will be sent to eight schools. Five participating schools, comprising 254 students will be divided into 20 classes. For pragmatic reasons, these schools will be randomly assigned to one of two groups, experimental or control, to create comparable and nearly equally sized groups, initially resulting in 111 students in the experimental group and 143 students in the control group.
3. In the first week, both groups will be asked to complete a questionnaire.
4. Two weeks after completing the first questionnaire, participants in the experimental group will be enrolled in the programme.
5. Three weeks after working with the programme, both groups will complete a follow-up questionnaire.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Alcohol use (lifetime prevalence and onset): students will be asked to indicate retrospectively how many standard units they consume during one drinking occasion.
2. Tobacco use (lifetime prevalence and onset).
Both outcomes will be measured with a self-report questionnaire at baseline. Furthermore, basic sociodemographic information will be available through a teacher-reported and student-reported questionnaire at baseline. Behavioural determinants (alcohol and tobacco knowledge; attitude; self-efficacy; intention; subjective norm) will be measured at baseline and 3 weeks after working with the programme (follow-up questionnaire).
Secondary outcome measures
-
Overall trial start date
01/06/2009
Overall trial end date
01/01/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 11–16 years old
2. Attending Dutch Special needs school, first or second grade
3. Intelligence quotient levels of between 50 and 85 according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision
4. Sufficient communication skills and ability to respond using Likert Scale categories
Participant type
Other
Age group
Child
Gender
Both
Target number of participants
210
Participant exclusion criteria
Not meeting the inclusion criteria
Recruitment start date
01/03/2010
Recruitment end date
01/07/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
OSG Erasmus - Praktijkonderwijs
Horstlaan 1
Almelo
7602 AM
Netherlands
Trial participating centre
Bonhoeffer Praktijk Locatie Vlierstraat
Vlierstraat 75
Enschede
7544 GG
Netherlands
Trial participating centre
Thomas a Kempis College
Palestrinalaan 915
Zwolle
8031 VA
Netherlands
Trial participating centre
Praktijkonderwijs Zutphen
Paulus Potterstraat 12A
Zutphen
7204 CV
Netherlands
Trial participating centre
De Maat Ommen
Baron van Fridaghstraat 137
Ommen
7731 DL
Netherlands
Sponsor information
Organisation
Aveleijn
Sponsor details
Grotestraat 260
Borne
7577 KS
Netherlands
Sponsor type
Other
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Aveleijn Intellectual Disabilities Services (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The plan is to publish a full article in the Journal of Intellectual Disability Research this year.
Intention to publish date
30/06/2015
Participant level data
Available on request
Basic results (scientific)
Publication list
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26631986