Adolescent substance use prevention
| ISRCTN | ISRCTN14512228 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14512228 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/11/2015
- Registration date
- 26/01/2016
- Last edited
- 07/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Grotestraat 260
Borne
7622 GW
Netherlands
 ORCID ID |
0000-0002-2802-6910 |
|---|
Study information
| Study design | Pre-/post intervention design with control group |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Pre-/Post intervention design with control group |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Substance use prevention program on special education schools |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2011 |
| Completion date | 01/03/2013 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 16 Years |
| Sex | 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. |
| Key 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 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/04/2011 |
| Date of final enrolment | 01/01/2012 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Hengelo
7577 PC
Netherlands
Almelo
7608 JD
Netherlands
Enschede
7523 ES
Netherlands
Sponsor information
Other
Grotestraat 260
Borne
7622 GW
Netherlands
"ROR" |
https://ror.org/03krr1g45 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/03/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We intend to publish a full article in the special issue of Research in Developmental Disabilities |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Thesis results | 14/01/2019 | 07/01/2022 | No | No |
Editorial Notes
07/01/2022: Link to thesis added.
27/01/2016: Internal review
