Condition category
Mental and Behavioural Disorders
Date applied
20/11/2015
Date assigned
26/01/2016
Last edited
27/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
It is thought that, in general, students start experimenting with tobacco and alcohol between the ages of 12 and 16. However there is, is yet, no information on when 12 to 16 year old students with intellectual disabilities (ID) start doing the same. Prevention programs, like “Prepared on time”, work well but have not been tested on students with ID. “Prepared on time”, a prevention program based on the attitude-social influence-efficacy model (ASE model), can be used in the 5th and 6th grades of primary schools. It is based on the future behaviour of a person being determined by, and closely related to, their intention. Intention is, in itself, determined by a person’s disadvantages, advantages, social acceptance of and norms, the pressures placed upon them and how much they believe they manage their own lives. The goal of this study was look at tobacco and alcohol use among 1st and 2nd graders in secondary special needs schools and to test the performance of the e-learning program “Prepared on time” for this population.

Who can participate?
Students aged 12-16 with ID.

What does the study involve?
Three schools agree to take part in the study. Two of these schools are randomly allocated to the experimental or control group. For the third school, to ensure groups of equal size, half the children are allocated randomly to the experimental group and half to the control group. In the first week, both the experimental group and the control group are asked to complete a questionnaire. Two weeks after completing the first questionnaire, participants in the experimental group are enrolled in the “Prepared on time” program. Three weeks after working with the program, all children in both groups complete the follow-up questionnaire.

What are the possible benefits and risks of participating?
The benefits for participating in the study include the students having the possibility of trying a new kind of prevention program and the teachers gaining more insight into the tobacco and alcohol use of their students. Risks include students being adversely affected by the intervention itself by getting them interested in tobacco or alcohol use.

Where is the study run from?
Three special education schools in the Netherlands

When is the study starting and how long is it expected to run for?
January 2011 to March 2013

Who is funding the study?
Aveleijn Intellectual Disabilities Services (Borne, The Netherlands)

Who is the main contact?
Mrs Marion Kiewik

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Marion Kiewik

ORCID ID

http://orcid.org/0000-0002-2802-6910

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 program on special education schools

Acronym

Study hypothesis

1. We assume a lower lifetime prevalence of tobacco and alcohol use among this population in the Netherlands.
2. We assume that the program ‘Prepared on time’ will increase the smoking and drinking knowledge of students with intellectual disabilities (ID). Further, we assume that 'Prepared on time' will influence behavioral determinants, based on the ASE model.

Ethics approval

Not provided at time of registration

Study design

Pre-/post intervention design with control group

Primary study design

Interventional

Secondary study design

Pre-/Post intervention design with control group

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Adolescents with mild intellectual disabilities, attending special secondary needs schools.

Intervention

The program “Prepared on time”, developed as a prevention program based on the ASE model, was originally used in the 5th and 6th grade of primary schools. This study was a pilot study among 73 students with a mild intellectual disabilities (ID).

An invitation letter was sent to six schools. Three schools, comprising 73 students, finally agreed to participate. For pragmatic reasons, two schools were assigned by lot to either the experimental and the control. The students in the third school were listwise assigned to either condition in order to create equal size groups, initially resulting in 37 students in the experimental group and 36 students in the control group.

In the first week, both the experimental group and the control group were interviewed to complete a questionnaire. Two weeks after completing the first questionnaire, participants in the experimental group were enrolled in the program. Three weeks after working with the program, both groups were interviewed again to complete the follow-up questionnaire. Finally, 69 students completed both questionnaires (35 students in the experimental group, 34 in the control group).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Alcohol use (lifetime prevalence and onset). Students are asked to indicate retrospectively, how many standard units they consumed in one drinking occasion.
2. Tobacco use (lifetime prevalence and onset).

Both measured with a self-report questionnaire at baseline.

3. Basic socio-demographic information will be available through a teacher-reported and student-reported questionnaire at baseline.
4. Behavioural determinants (Alcohol and tobacco knowledge; Attitude; Modelling; Social Pressure; Intention) were measured at baseline and three weeks after working with the program (follow-up questionnaire).

In the first week, both the experimental group and the control group were asked to complete a questionnaire. Two weeks after completing the first questionnaire, participants in the experimental group were enrolled in the program. Three weeks after working with the program, both groups completed the follow-up questionnaire.

Secondary outcome measures

Feasibility of the e-learning program by asking participants’ experiences working with the program (11 questions in the follow-up questionnaire), measured 3 weeks after completion of the e-learning program.

Overall trial start date

01/01/2011

Overall trial end date

01/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age between 12 - 16
2. Attending Dutch Special needs school, first or second class
3. IQ levels between 50 and 70 according to ICD-10 criteria measured by regular intelligence tests
4. Sufficient communication skills and ability to respond using Likert Scale categories

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

This study was a pre-/post-intervention study with control group among 73 students with a mild ID. An invitation letter was sent to six schools. Three schools, comprising 73 students, finally agreed to participate. For pragmatic reasons, two schools were assigned by lot to either the experimental and the control. The students in the third school were listwise assigned to either condition in order to create equal size groups, initially resulting in 37 students in the experimental group and 36 students in the control group.

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/2011

Recruitment end date

01/01/2012

Locations

Countries of recruitment

Netherlands

Trial participating centre

VSO "Het Korhoen"
Korhoenstraat 2
Hengelo
7577 PC
Netherlands

Trial participating centre

VSO "De Brug"
Burcht 107
Almelo
7608 JD
Netherlands

Trial participating centre

Het Meerik VSO (formerly known as "VSO De Huifkar")
Lijsterstraat 117
Enschede
7523 ES
Netherlands

Sponsor information

Organisation

Aveleijn

Sponsor details

Grotestraat 260
Borne
7622 GW
Netherlands

Sponsor type

Other

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Aveleijn Intellectual Disabilities Services (Borne, The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish a full article in the special issue of Research in Developmental Disabilities

Intention to publish date

01/03/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

27/01/2016: Internal review