Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ISRCTN |
Last refreshed on:
|
17 January 2022 |
Main ID: |
ISRCTN14512228 |
Date of registration:
|
26/01/2016 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Adolescent substance use prevention
|
Scientific title:
|
Substance use prevention program on special education schools |
Date of first enrolment:
|
01/04/2011 |
Target sample size:
|
73 |
Recruitment status: |
Completed |
URL:
|
https://www.isrctn.com/ISRCTN14512228 |
Study type:
|
Interventional |
Study design:
|
Pre-/post intervention design with control group (Prevention)
|
Phase:
|
Not Applicable
|
|
Countries of recruitment
|
Netherlands
| | | | | | | |
Contacts
|
Name:
|
|
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
|
Name:
|
Marion
Kiewik |
Address:
|
Grotestraat 260
7622 GW
Borne
Netherlands |
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
| |
Key inclusion & exclusion criteria
|
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
Exclusion criteria: Does not meet inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Adolescents with mild intellectual disabilities, attending special secondary needs schools. Mental and Behavioural Disorders
|
Intervention(s)
|
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).
|
Primary Outcome(s)
|
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(s)
|
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.
|
Source(s) of Monetary Support
|
Aveleijn Intellectual Disabilities Services (Borne, The Netherlands)
|
Ethics review
|
Status:
Approval date:
Contact:
Not provided at time of registration
|
Results
|
Results available:
|
Yes |
Date Posted:
|
|
Date Completed:
|
01/03/2013 |
URL:
|
|
|
|