Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ricardo Araya

ORCID ID

Contact details

Cotham House
Cotham Hill
Bristol
BS6 6JL
United Kingdom
r.araya@bris.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

082584; Version 3

Study information

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

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

Ethics approval

Hospital Clinico Universidad de Chile Ethics Board approved on the 30th June 2008 (ref: 178)

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Depression

Intervention

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

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Beck Depression Inventory at 3 months after completing intervention

Secondary outcome measures

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

Overall trial start date

01/04/2009

Overall trial end date

31/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

All students will be invited to participate (ages 13 - 15 years, either sex)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

2634

Participant 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.

Recruitment start date

01/04/2009

Recruitment end date

31/07/2011

Locations

Countries of recruitment

Chile

Trial participating centre

Cotham House
Bristol
BS6 6JL
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom
+44 (0)117 928 8676
Christine.Nileshwar@bristol.ac.uk

Sponsor type

University/education

Website

http://www.bristol.ac.uk/research

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 082584)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21333015
2. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23999656

Publication citations

  1. Protocol

    Araya R, Montgomery AA, Fritsch R, Gunnell D, Stallard P, Noble S, Martinez V, Barroilhet S, Vohringer P, Guajardo V, Cova F, Gaete J, Gomez A, Rojas G, School-based intervention to improve the mental health of low-income, secondary school students in Santiago, Chile (YPSA): study protocol for a randomized controlled trial., Trials, 2011, 12, 49, doi: 10.1186/1745-6215-12-49.

  2. Results

    Araya R, Fritsch R, Spears M, Rojas G, Martinez V, Barroilhet S, Vöhringer P, Gunnell D, Stallard P, Guajardo V, Gaete J, Noble S, Montgomery AA, School intervention to improve mental health of students in Santiago, Chile: a randomized clinical trial., JAMA Pediatr, 2013, 167, 11, 1004-1010, doi: 10.1001/jamapediatrics.2013.2361.

Editorial Notes