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
Secondary identifying numbers	N/A

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

c/o HealthNet TPO
Tolstraat 127
Amsterdam
1074 VJ
Netherlands

Phone	+31 (0)20 6200005
Email	jdejong@healthnettpo.org

Study information

Study design	Cluster randomization of schools to intervention (structured school-based psychosocial program) or waitlist condition (receiving treatment after the research)
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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	Post-traumatic stress disorder (PTSD) and depressive symptoms
Secondary outcome measures	Anxiety, aggression, daily functioning, social support, sociometric measurements (sociogram), coping, family functioning, hope, and school functioning (grades, absenteeism)
Overall study start date	01/07/2006
Completion date	31/03/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	120 per treatment arm; total 240 children
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

Sponsor information

HealthNet TPO (The Netherlands)
Charity

Tolstraat 127
Amsterdam
1074 VJ
Netherlands

Phone	+31 (0)20 6200005
Email	jdejong@healthnettpo.org
Website	http://www.healthnettpo.org
"ROR"	https://ror.org/0088fqs38

Funders

Funder type

Charity

Plan International

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?
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.