The aim of the study is to establish depression and suicide prevention reaching students who attend special education.The primary goal is to evaluate the effectiveness on depressive symptoms of a screening and prevention program for adolescents who…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is depressive symptomatology.
Secondary outcome
Secondary study parameters are suicidality, anxiety and somatic complaints,
depression and axiety according to parents.
Other study parameters are possible baseline differences between the two groups
in demographic variables. Besides: Educational history, reason for attending
special schools, diagnosis and full scale IQ.
Background summary
Depression is a major public health concern. In Dutch adolescents, the
prevalence of major depressive disorder is estimated at 3.8% (Meijer, Smit,
Schoemaker & Cuijpers, 2006) and 23.4% report depressive symptoms (van den
Heuvel et al, 2021). Depression is a risk factor in adolescent suicide (Fried,
Williams, Cabral, Hacker, 2013). Prevention programs, for example the STORM
approach, are effective in decreasing depressive symptoms among adolescents
with elevated depressive symptoms at screening (De Jonge-Heesen, et al., 2020).
Besides, the prorgram helps detecting sui*cidal adolescents, and guides them to
mental healthcare. However, not all adolescents attend general education. In
the Netherlands, 7% of all adolescents enters special education (voortgezet
speciaal onderwijs and prakijkonderwijs; Rijksoverheid, 2022). These
adolescents form a vulnerable subgroup concerning developing depressive
symptoms and suicidality, but are usually left out in the (initial) development
of programs. To adapt programs for these students, and to implement prevention
in special schools, is a crucial next step. This study aims to screen
adolescents, offer them a prevention program to prevent the onset or
continuation of depression and evaluate the effectiveness of this program.
Study objective
The aim of the study is to establish depression and suicide prevention reaching
students who attend special education.
The primary goal is to evaluate the effectiveness on depressive symptoms of a
screening and prevention program for adolescents who experience depressive
symptoms. The secondary goal is to find factors which possibly relate to the
effectiveness of the prevention program.
Study design
Clusterend randomised controlled trial with two conditions (intervention versus
waitlist). Randomization is clustered by school-type and will take place before
the study starts.
Intervention
Participants in the experimental condition will be offered the CBT-based
preventive group training Op Volle Kracht. This consists of eight lessons and
seven check-in moments, thaught by two experienced mental health professionals.
The lessons takes place during school hours and the group consists of three to
five participants. The control condition will consist of monitoring and is
offered the training after data collection of the study has ended and when the
intervention has shown to be effective. All participants will fill in
longitudinal measurements. At all times, adolescents will be guided to mental
health care if necessary.
Furthermore, teachers in all participating schools will attend a training on
how to detect and address depressive and suicidal symptoms among adolescents.
Study burden and risks
The potential value of the study is that we can offer adolescents in the
special educational sector a prevention program that is proven to be effective.
Besides, we can detect and refer adolscents presenting with suïcidality in an
early stage. In order to achieve this goal we need to evaluate the
effectiveness of this prevention program in this target group.
We are of opinion, that the risks associated with participation can be
considered negligible. Participation consists of filling in questionnaires
(adolescents and their parents) to determine the effectiveness of the
intervention. Participation might lead to more efficient prevention. The new
aspect of this prevention program is that it is specifically aimed at
depressive symptoms, within a vulnerable and young subgroup.
Gezondheidslaan 65
Oss 5342 JW
NL
Gezondheidslaan 65
Oss 5342 JW
NL
Listed location countries
Age
Inclusion criteria
Adolescents attend second or third grade of secondary special education OR
(only if a special school does not operate in grades) adolescents will reach
the age of 14 or 15 during this academic year
Attending special school (voortgezet speciaal onderwijs or praktijkonderwijs)
Score above the cut-off on an depression symptomlist (>= 14 on the CDI-2)
Exclusion criteria
Adolescents who score 2 on item 8 of the CDI-2 or >= 23 on the VOZZ-screen
(suicidality)
Clinical depression based on the clinical interview held at baseline (ADIS-C)
Absence of parental permission
Adolescent already receiving treatment for depressive symptomatology
Insufficient knowledge of the Dutch language
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06203899 |
| CCMO | NL83816.091.23 |