Determine if HL meets the criteria for the higher DEI designation of effectiveness. We will investigate the effectiveness of HL in terms of an increase in well-being and a reduction of depressive symptoms after 6 months compared to care as usual.
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are well-being and depressive symptoms. These will
be measured by pupils self-reports at all four assessment points (e.g., T0-T3).
The primary outcome measurement will be the 6-months follow-up measurement
(T3). Depressive symptoms will be measured with the Dutch version of the
self-report questionnaire Center for Epidemiologic Studies Depression Scale
(CES-D) (Bouma et al., 2012; Schroevers et al., 2000). Well-being will be
measured with the Dutch translation of the Warwick-Edinburgh Mental Well-Being
Scale (WEMWBS) (Ikink, Lamers, & Bolier, 2012; Tennant et al., 2007).
Secondary outcome
Life satisfaction will be assessed with the Cantril Ladder (Cantril, 1965).
demographic characteristics (i.e., gender, age, immigration background) and
questionnaires measuring the pupils perceived school climate (i.e., classmate
support, teacher support, bullying involvement, bullying victimization, school
connectedness, and perceived schoolwork pressure). The mental health
professionals who deliver HL will fill in an online questionnaire after the
final individual consultation session on how many pupils the referred to
additional help and what type of help they referred the pupils too (e.g., some
additional individual sessions with the mental health professional themselves
or other appropriate local care). We will also evaluate the implementation of
HL to gain insight in the results of the study and warrant successful future
implementation for scale up of HL.
Background summary
Happy Lessons (HL) is a school-based program to promote well-being and prevent
depression among young people. It is specifically developed for young people in
lower education. HL has been thoroughly evaluated and optimized and is
recognized as theoretically sound by the Dutch Recognition System for
Interventions (DEI). In the DEI a proven effective school-based depression
program is missing yet for lower educated young people.
Study objective
Determine if HL meets the criteria for the higher DEI designation of
effectiveness. We will investigate the effectiveness of HL in terms of an
increase in well-being and a reduction of depressive symptoms after 6 months
compared to care as usual.
Study design
The objective will be addressed in a cluster Randomized Controlled Trail in two
parallel groups comparing an experimental condition (receiving HL during the
study) and a control condition (CAU waitlist condition, with HL not delivered
until after the final follow-up assessment).
Intervention
HL is a school-based program to promote well-being and prevent depression among
young people. It is specifically developed for young people in lower education
and provided by a mental health professional. It consists of: (a) four
classroom lessons, two face-to-face lessons and two e-lessons, (b) an online HL
test that includes two well-being scales and a depression scale that is
administered at the beginning and end of the classroom lessons, (c) an
individual consultation session with the mental health professional who
delivers HL for each pupil, and (d) an additional help offer for high-risk
pupils.
Study burden and risks
Previous research concerning the various aspects of our study has shown no risk
for pupils: pilot studies of the HL classroom sessions (without control group)
have shown promising results, with depressive symptoms reduced and well-being
enhanced; the largest effects were found in pupils with elevated depression
level. Pupils have also given positive ratings to both the classroom-delivered
HL and the subsequent individual advice sessions. In this study both the
experimental and control groups will have access to HL. The only differences is
that the experimental condition receives HL earlier than the control condition.
Moreover, all participants have access to standard usual care delivered at
their schools.
Da Costakade 45
Utrecht 3521 VS
NL
Da Costakade 45
Utrecht 3521 VS
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, recruited schools must
meet all of the following criteria: both (1) the school authorities and (2) the
community or mental health service whose duty it is to provide services for the
school must agree to adhere to the HL protocol. In addition, (3) each school
should include at least two school classes within at least one school year
(e.g., either school year one or two).
In order to be eligible to participate in this study, students must meet all of
the following criteria:
1. Enrolment in either the first or second school year of pre-vocational
education.
2. Informed consent of the parent(s).
3. Informed consent of the pupil.
4. Sufficient command of the Dutch language
Exclusion criteria
1. No informed consent from the parent(s)
2. No informed consent from the pupil
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL77336.041.21 |