Adolescent substance use prevention
| ISRCTN | ISRCTN95279686 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95279686 |
| Secondary identifying numbers | N/A |
- Submission date
- 01/02/2015
- Registration date
- 10/02/2015
- Last edited
- 04/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Radboud Universiteit Nijmegen/ACSW
NISPA
Postbus 6909
Nijmegen
6503 GK
Netherlands
 ORCID ID |
0000-0002-2802-6910 |
|---|
Public
Grotestraat 260
Borne
7622 GW
Netherlands
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Prevention |
| Scientific title | Substance use prevention programme in special education schools: a cluster randomised control trial |
| Study objectives | 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(s) | Boards of the participating schools; approval date and reference not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/06/2009 |
| Completion date | 01/01/2011 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 210 |
| Key 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 |
| Key exclusion criteria | Not meeting the inclusion criteria |
| Date of first enrolment | 01/03/2010 |
| Date of final enrolment | 01/07/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Almelo
7602 AM
Netherlands
Enschede
7544 GG
Netherlands
Zwolle
8031 VA
Netherlands
Zutphen
7204 CV
Netherlands
Ommen
7731 DL
Netherlands
Sponsor information
Other
Grotestraat 260
Borne
7577 KS
Netherlands
| Website | www.aveleijn.nl |
|---|---|
"ROR" |
https://ror.org/03krr1g45 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/06/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The plan is to publish a full article in the Journal of Intellectual Disability Research this year. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2016 | Yes | No |
Editorial Notes
04/12/2015: Publication reference added.
