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Randomised controlled trial of a school-based intervention to improve the mental health of low-income, secondary school students in Santiago, Chile
ISRCTN ISRCTN19466209
DOI 10.1186/ISRCTN19466209
ClinicalTrials.gov identifier
EudraCT number
Public title Randomised controlled trial of a school-based intervention to improve the mental health of low-income, secondary school students in Santiago, Chile
Scientific title Cluster randomised controlled trial of a school-based intervention to improve the mental health of low-income, secondary school students in Santiago, Chile
Acronym YPSA
Serial number at source 082584; Version 3
Study hypothesis 1. Students receiving the intervention will achieve lower scores (difference in mean of at least 0.4 standard deviations) in the depressive questionnaire in comparison to the control group 3 months after completing the course
2. Symptomatic improvements achieved at 3 months will be maintained until the final assessment 12 months after completing the course
3. The intervention will be more effective at 3 and 12 months follow up among students with higher depression scores at baseline
4. Students receiving the intervention will show greater reductions in negative thoughts and improvements in problems solving skills than those in the control group
Lay summary Not provided at time of registration
Ethics approval Hospital Clinico Universidad de Chile Ethics Board approved on the 30th June 2008 (ref: 178)
Study design Cluster randomised controlled trial
Countries of recruitment Chile
Disease/condition/study domain Depression
Participants - inclusion criteria All students will be invited to participate (ages 13 - 15 years, either sex)
Participants - exclusion criteria Students in either trial arm with severe depressive episodes, according to Beck Dpression Inventory (BDI-II) baseline assessment, but with no marked suicidal ideation will be invited to attend but also encouraged to seek professional advice. Students with marked suicidal ideation at baseline in either group will be referred for a clinical assessment in their primary care clinic. Students admitted to hospital for mental health reasons during the trial and those with serious alcohol/drug use will be advised to continue with their prescribed treatment and in case of doubt will be referred for a clinical assessment.
Anticipated start date 01/04/2009
Anticipated end date 31/07/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 2634
Interventions Intervention:
The intervention will be based on a CBT model delivered to all students in the class during school hours. The programme consists of 11 weekly and 3 booster group sessions each lasting one hour. There is an introductory session, 5 sessions dealing with thought re-structuring, 1 session related to identifying emotions, 3 with problem solving and 1 closing session with a revision of the learning and planning for the future.

Eight trios of trained research workers (psychologists, teachers, social workers, and others) deliver the intervention. These workers will have a detailed manual specifying key learning points and objectives for each session and students will receive a similar but shortened workbook. Methods include didactic sessions; small group and class interactive exercises.

Three additional booster sessions will be delivered at 2, 7, and 9 months after the intervention is completed. Teachers assist with the discipline of the class in special circumstances. Facilitators receive five days of training which cover the identification and management of mental health concerns, group management techniques as well as training to deliver the specific intervention. The intervention is fully manualised. During the course weekly supervision groups will be provided for facilitators.

Control:
The control group will receive nothing other than the normal teaching activities and assessments. At present all classes receive one curricular hour weekly for counselling delivered by their head-teachers. We will advise teachers to put more emphasis on emotional problems for 12 weeks giving more and better information, allowing students to exchange experiences and provide mutual support. If the active intervention proves to be more effective, we will implement the course in all control schools after completion of the trial.

Duration of course: 3 months plus 3 booster sessions in the following 18 months
Duration of follow up: 3 and 12 months after completing intervention
Primary outcome measure(s) Beck Depression Inventory at 3 months after completing intervention
Secondary outcome measure(s) 1. Revised Child Anxiety and Depression Scale (RCADS). We will exclude the depression and separation anxiety sub-scales because these are either covered by other scales or irrelevant to students of this age.
2. School records of academic performance: we will only use grades obtained through formal testing because these are standardised across schools
Sources of funding The Wellcome Trust (UK) (grant ref: 082584)
Trial website
Publications 1. 2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21333015
2. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23999656
Contact name Prof  Ricardo  Araya
  Address Cotham House
Cotham Hill
  City/town Bristol
  Zip/Postcode BS6 6JL
  Country United Kingdom
  Email r.araya@bris.ac.uk
Sponsor University of Bristol (UK)
  Address Senate House
Tyndall Avenue
  City/town Bristol
  Zip/Postcode BS8 1TH
  Country United Kingdom
  Tel +44 (0)117 928 8676
  Fax +44 (0)117 929 8383
  Email Christine.Nileshwar@bristol.ac.uk
  Sponsor website: http://www.bristol.ac.uk/research
Date applied 07/11/2010
Last edited 04/09/2013
Date ISRCTN assigned 10/11/2010
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