Contact information
Type
Scientific
Primary contact
Prof Joop de Jong
ORCID ID
Contact details
c/o HealthNet TPO
Tolstraat 127
1074 VJ
Amsterdam
1074 VJ
Netherlands
+31 (0)20 6200005
jdejong@healthnettpo.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Ongoing at ethical review board of Vrije Universiteit Amsterdam as of 09/06/06
Study design
Cluster randomisation 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
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Post-traumatic stress disorder (PTSD) and depressive symptoms
Secondary outcome measures
1. Anxiety
2. Aggression
3. Daily functioning
4. Social support
5. Sociometric measurements (sociogram)
6. Coping
7. Family functioning
8. Hope
9. School functioning (grades, absenteeism)
Overall trial start date
15/03/2006
Overall trial end date
31/05/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Children screened for exposure to traumatic events, post-traumatic stress symptoms or depressive anxiety symptoms, with the use of symptom checklists
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
110 per treatment arm (10 selected groups); total 240 children
Participant 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
Recruitment start date
15/03/2006
Recruitment end date
31/05/2007
Locations
Countries of recruitment
Indonesia
Trial participating centre
c/o HealthNet TPO
Amsterdam
1074 VJ
Netherlands
Sponsor information
Organisation
HealthNet TPO (The Netherlands)
Sponsor details
Tolstraat 127
1074 VJ
Amsterdam
1074 VJ
Netherlands
+31 (0)20 6200005
jdejong@healthnettpo.org
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Plan International (UK)
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/18698064
Publication citations
-
Results
Tol WA, Komproe IH, Susanty D, Jordans MJ, Macy RD, De Jong JT, School-based mental health intervention for children affected by political violence in Indonesia: a cluster randomized trial., JAMA, 2008, 300, 6, 655-662, doi: 10.1001/jama.300.6.655.