Efficacy of a school-based psychosocial intervention to deal with the psychosocial impact of armed conflict on school-aged children in Sri Lanka
| ISRCTN | ISRCTN66249480 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66249480 |
| Protocol serial number | N/A |
| Sponsor | HealthNet TPO (The Netherlands) |
| Funder | Plan International |
- Submission date
- 24/02/2006
- Registration date
- 09/06/2006
- Last edited
- 08/01/2021
- 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 Joop de Jong
Scientific
Scientific
c/o HealthNet TPO
Tolstraat 127
Amsterdam
1074 VJ
Netherlands
| Phone | +31 (0)20 6200005 |
|---|---|
| jdejong@healthnettpo.org |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomization of schools to intervention (structured school-based psychosocial program) or waitlist condition (receiving treatment after the research) |
| Secondary study design | Randomised controlled trial |
| Scientific title | Efficacy of a school-based psychosocial intervention to deal with the psychosocial impact of armed conflict on school-aged children in Sri Lanka |
| Study objectives | A psychosocial school-based program is capable of reducing conflict-related psychosocial symptoms, and increasing children's strength to deal with armed-conflict related psychosocial difficulties |
| Ethics approval(s) | Ongoing at ethical review board of Vrije Universiteit Amsterdam as of 09/06/06 |
| Health condition(s) or problem(s) studied | Multiple impact of armed conflict on psychosocial wellbeing (post-traumatic stress disorder) |
| Intervention | Classroom-based structured, manualized psychosocial intervention, called the class-room based intervention (CBI), as designed by the Center for Trauma Psychology (Boston, Massachusetts) versus the waitlist condition. The CBI entails a 15-session program that encompasses working with the trauma narrative, creative techniques (drama, music), and specifically designed games. The waitlist condition simply entails the provision of treatment after the research is finished. |
| Intervention type | Other |
| Primary outcome measure(s) |
Post-traumatic stress disorder (PTSD) and depressive symptoms |
| Key secondary outcome measure(s) |
Anxiety, aggression, daily functioning, social support, sociometric measurements (sociogram), coping, family functioning, hope, and school functioning (grades, absenteeism) |
| Completion date | 31/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 240 |
| Total final enrolment | 399 |
| Key inclusion criteria | Children screened for exposure to traumatic events, post-traumatic stress symptoms or depressive anxiety symptoms, with the use of symptom checklists |
| Key exclusion criteria | Serious psychopathology and psychiatric disorders (mutism, retardation, psychotic symptoms) or incapability to function in a group (conduct disorders, harming others), as judged by local psychosocial counsellors |
| Date of first enrolment | 01/07/2006 |
| Date of final enrolment | 31/03/2007 |
Locations
Countries of recruitment
- Netherlands
- Sri Lanka
Study participating centre
c/o HealthNet TPO
Amsterdam
1074 VJ
Netherlands
1074 VJ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2012 | 08/01/2021 | Yes | No |
Editorial Notes
08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
