|- candidate number||28120|
|- NTR Number||NTR6888|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-okt-2017|
|- Secondary IDs||2017-PC-8244 |
|- Public Title||Discussions in the classroom: Investigating the role of interpersonal communication of teachers and students within a school-based health intervention|
|- Scientific Title||Discussions in the classroom: Investigating the role of interpersonal communication of teachers and students within a school-based health intervention|
|- Healt Condition(s) or Problem(s) studied||Unhealthy snacking habits, Excessive alcohol intake|
|- Inclusion criteria||Adolescents (16+) VMBO, MBO, HAVO, VWO students.
MEC approval not needed as the study is nonmedical (no hospital or patients are involved).
|- Exclusion criteria||No exclusion criteria.|
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2017|
|- planned closingdate||1-jun-2019|
|- Target number of participants||1120|
|- Interventions||- In Charge school intervention (e.g., self-control, social norms, self-efficacy, attitudes)|
- Control condition (Do not receive anything until the randomized controlled trial has ended)
|- Primary outcome||We will measure the following variables:
Behavior: Past and current behavior.
Behavioral determinants: Intention, self-efficacy (non-use and refusal), social norms (injunctive and descriptive), attitudes (cognitive and affective), likelihood and evaluation of behavioral (dis)advantages.
Interpersonal communication with several discussion partners (parents, teacher, friends, and classmates): frequency of discussions, valence of discussions, topic of discussions.
|- Secondary outcome||Personality variables: perceived self-control, perceived ability to resist temptations.
Student evaluation of teacher: Clarity, verbal immediacy, affinity, teaching style, emotional support, classroom organization, instructional support, attitude towards the teacher, adherence to intervention, and content relevance.
Student evaluation of intervention: self-evaluation, state motivation, learning climate questionnare, and attitude towards the intervention, perceived relevance of the intervention.
Demographic information: Gender, age, nationality, parents' nationality, type of education, home situation.
In addition, we also plan to interview students and teachers about the intervention and their conversations with others about the intervention.
|- Timepoints||Measures will be administered three times. One week before the intervention, one week after the intervention, and 12 weeks after the intervention. |
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Mathijs Mesman|
|- CONTACT for SCIENTIFIC QUERIES|| Mathijs Mesman|
|- Sponsor/Initiator ||University of Amsterdam (UvA), Trimbos-institute - Netherlands Institute of Mental Health and Addiction|
(Source(s) of Monetary or Material Support)
|Ministry of Health, Welfare and Sports|
|- Brief summary||The Trimbos institute has developed a new school health intervention aimed at increasing self-control of older adolescents (16+) to resist unhealthy behaviors such as alcohol and unhealthy snacks.
Interpersonal communication has been shown to be an important factor in the context of mass mediated health interventions. It has been shown that interpersonal communication mediates or moderates the effects of such interventions. Also, studies showed that interpersonal communication generally has more effects than health intervention exposure.
In this randomized controlled trial, we investigate the effectiveness of the intervention as well as how the effects depend on interpesonal communication.
|- Main changes (audit trail)|
|- RECORD||30-okt-2017 - 28-dec-2017|