Condition category
Mental and Behavioural Disorders
Date applied
01/02/2015
Date assigned
10/02/2015
Last edited
04/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

www.aveleijn.nl

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

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26631986

Publication citations

Additional files

Editorial Notes

04/12/2015: Publication reference added.