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
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