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 | https://doi.org/10.1186/ISRCTN19466209 |
| Secondary identifying numbers | 082584; Version 3 |
- Submission date
- 07/11/2010
- Registration date
- 10/11/2010
- Last edited
- 04/09/2013
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Ricardo Araya
Scientific
Scientific
Cotham House
Cotham Hill
Bristol
BS6 6JL
United Kingdom
| r.araya@bris.ac.uk |
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | YPSA |
| Study objectives | 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(s) | Hospital Clinico Universidad de Chile Ethics Board approved on the 30th June 2008 (ref: 178) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/04/2009 |
| Completion date | 31/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | 2634 |
| Key inclusion criteria | All students will be invited to participate (ages 13 - 15 years, either sex) |
| Key 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. |
| Date of first enrolment | 01/04/2009 |
| Date of final enrolment | 31/07/2011 |
Locations
Countries of recruitment
- Chile
- England
- United Kingdom
Study participating centre
Cotham House
Bristol
BS6 6JL
United Kingdom
BS6 6JL
United Kingdom
Sponsor information
University of Bristol (UK)
University/education
University/education
Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom
| Phone | +44 (0)117 928 8676 |
|---|---|
| Christine.Nileshwar@bristol.ac.uk | |
| Website | http://www.bristol.ac.uk/research |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 082584)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 19/02/2011 | Yes | No | |
| Results article | results | 01/11/2013 | Yes | No |
