Evaluation of a school-based mental health program

ISRCTN	ISRCTN28974509
DOI	https://doi.org/10.1186/ISRCTN28974509
Secondary identifying numbers	N/A

Submission date: 30/03/2015
Registration date: 14/04/2015
Last edited: 14/04/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Depression or persistent feelings of sadness and hopelessness lowers the quality of life in adolescents. Depression can also block progress in learning and development of social and emotional skills. In recent times there has been a big increase in Swedish adolescents reporting feeling depressed or experiencing stress. Preventing depression in adolescents can both lessen individual suffering and lower the costs (financial and social) associated with the disorder. Treatments aimed at preventing depression or depressed feelings in adolescents are being used more and more within the school system. This is often in the form of group-based programs led by school nurses, school social workers or teachers. An example of such a program used frequently in Sweden today is called Depression in Swedish Adolescents (DISA). Group participants don’t have to have depression so it’s a universal prevention program. DISA involves ten structured 1.5 hour group sessions held once a week. The groups have around ten participants and are led by group leaders trained in the DISA method. DISA is usually used with girls in grade 8 (age 14). The aim of this study is to see whether interventions using DISA work well in preventing depression in adolescents, both boys and girls, and to also see what the health-economic benefits of the program might be.

Who can participate?
Male and female students in grade 8 (Sweden).

What does the study involve?
Participants are divided into two groups: students who attend DISA-program meetings which are held during school hours, and students who attend school as usual. The program is held on school premises and is carried out by trained and experienced DISA tutors who are school nurses, school social workers or teachers. Participants complete survey questionnaires which are given at different times during the course of the study. All participants also have both group and individual interviews.

What are the possible benefits and risks of participating?
A benefit of participating is that it will help provide information on whether a universal depression prevention program in schools can help lower the number of adolescents suffering from depression.

Where is the study run from?
Schools in six municipalities in southern Sweden.

When is the study starting and how long is it expected to run for?
March 2012 to June 2018

Who is funding the study?
Kristianstad University (Sweden)

Who is the main contact?
Pernilla Garmy (Sweden)
pernilla.garmy@hkr.se

Contact information

Ms Pernilla Garmy
Scientific

Kristianstad University
Kristianstad
291 88
Sweden

ORCID ID	0000-0003-1643-0171
Phone	+46 (0) 44 208589
Email	pernilla.garmy@hkr.se

Study information

Study design	Quasi-experimental longitudinal design
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	School
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title	Preventing mental disorders in adolescents with school based systematic interventions: an effectiveness study in a school setting
Study objectives	DISA originates from a program developed in the US called the Coping With Stress course (CWS) which was directed at teenagers (boys and girls), especially those with evidence of depressive symptoms. CWS was found to be effective in the US however no study has been carried out to see whether the Swedish DISA-program is effective in Sweden. Health-economic evaluations of school based programs aimed at preventing depression in adolescents in Sweden have been lacking thus far, and both the National Board of Health and Welfare and the Swedish Council on Health Technology Assessment have called for such studies. Thus, the the aim of this study is to examine whether the mental health program DISA is feasible and promotes well-being and mental health in adolescents.
Ethics approval(s)	Ethics Committee Lund University, 15/08/2012, ref: 2012/462
Health condition(s) or problem(s) studied	Depression
Intervention	School based DISA-program (a cognitive behavioral, manual based, program)
Intervention type	Behavioural
Primary outcome measure	Depressive symptoms and health related quality of life: 1. Survey at three time-points: baseline, 3 and 12 months, with follow-up at 2, 3, and 4 years. Survey questionnaires concern depression, anxiety, sleep, salutogenic health and quality of life (Center for Epidemiologic Studies Depression Scale (CES-D), Spence Children's Anxiety Scale (SCAS) and EQ-5D™, Salutogenic Health Indicator Scale (SHIS), Insomnia Severity Index, respectively) and are distributed to 300 adolescents belonging to the intervention group, and to 300 belonging to the control group 1.1 Aim: investigate whether DISA is effective in preventing depression in adolescents 2. Focus group interviews with those leading the sessions and with the adolescents participating in them 2.1 Aim: to determine how both those leading the sessions and the adolescents participating in them viewed DISA 3. Interviews with the adolescents 3.1 Aim: learn how the adolescents experienced their participation in DISA 4. Health economic evaluation 4.1 Aim: study the cost effectiveness of DISA
Secondary outcome measures	1. Feasibility and cost-effectiveness
Overall study start date	01/03/2012
Completion date	30/06/2018

Eligibility

Participant type(s)	Mixed
Age group	Child
Lower age limit	14 Years
Sex	Both
Target number of participants	1500
Key inclusion criteria	1. At baseline the participants are students in grade 8 (aged ~14)
Key exclusion criteria	No exclusion criteria
Date of first enrolment	01/09/2012
Date of final enrolment	30/06/2017

Locations

Countries of recruitment

Sweden

Study participating centres

Kristianstad University

Department of Health and Society
Kristianstad
291 88
Sweden

Lund University

Centre for Primary Health Care Reserach
Lund
Sweden

Sponsor information

Kristianstad University
University/education

Department of Health and Society
Kristianstad
291 88
Sweden

Website	www.hkr.se
"ROR"	https://ror.org/00tkrft03

Funders

Funder type

University/education

Kristianstad University

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	We want to publish data in 2015 - 2018 (findings from the 1 year follow-up can be published in 2015, findings from the 2, 3 and 4 year follow-up can be published 2016-2018).
IPD sharing plan