Outcome study on the classroom/camp/community-based intervention for children exposed to armed conflict in Nepal

ISRCTN	ISRCTN48004304
DOI	https://doi.org/10.1186/ISRCTN48004304
Secondary identifying numbers	N/A

Submission date: 06/12/2006
Registration date: 10/01/2007
Last edited: 14/01/2021

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

Mr Mark Jordans
Scientific

Lazimpat
Kathmandu
PO 8974 CPC 612
Nepal

Phone	+977 (0)1 4428439
Email	mjordans@healthnettpo.org

Study information

Study design	Randomised Controlled Trial (cluster randomisation)
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Scientific title	Outcome study on the classroom/camp/community-based intervention for children exposed to armed conflict in Nepal
Study objectives	Classroom/Camp/Community-Based Intervention (CBI) will improve daily functioning and reduce psychological distress.
Ethics approval(s)	Research design has been reviewed and approved by the Ethical Review Committee of the Vrije Universiteit Amsterdam (Free University) and is currently under review at the Nepal Health Research Council.
Health condition(s) or problem(s) studied	Healthy children who have been exposed to extreme stressors
Intervention	The intervention on which research takes place is the Classroom Based (or Community-Based or Camp-Based) Intervention (CBI) as developed by the Centre for Trauma Psychology in Boston. This is a highly structured community-based intervention, which aims at increasing childrens capacity to deal with the psychosocial problems that having been/being exposed to extreme stressors can cause, and aims to include components that enhance existing resources to deal with these consequences (individual coping methods, play, social support, existing rituals, etc.). It entails a five-week long, 15-session intervention implemented with groups of children in a class-room, refugee-camp or orphanage setting. It includes mainly group activities (including games, music, art, and drama). Structure is present between sessions and within sessions. Between sessions there is a build-up of activities; in the first two weeks activities are aimed at stabilising traumatic stress reactions, securing a safe place and building internal resources. In the third week and fourth week activities are aimed at exposure to the possible difficult reactions and memories associated with the conflict, through non-verbal means and in the final, fifth week activities are aimed at identifying and installing external and internal resources and coping strategies. Within sessions the following format is use: 1. Sessions start with a get together around a circular coloured object representing unity and safety (parachute), while simple hand/body movements and dancing are done 2. The second part of the sessions focuses on what is the central topic for today, e.g. drawing your own body with the places where you feel strength 3. The third part of the session is a cooperative game (games with special rules about inclusion, competition, safety and working together), and the session ends with 4. A final get together around the parachute to say goodbye. The control group will be a waitlist condition. After T2 measurement the control group will receive the same treatment as the Study Group; i.e. the 15-session Classroom Based Psychosocial Intervention (CBI).
Intervention type	Other
Primary outcome measure	1. Reduction in psychological symptoms 2. Post Traumatic Stress Disorder (PTSD) symptoms 3. Depression symptoms 4. Anxiety symptoms 5. Agression symptoms
Secondary outcome measures	Measuring change in resilience outcomes, such as: 1. Coping 2. Pro-social behaviour 3. Self-efficacy as well as change in Daily Functioning.
Overall study start date	01/01/2007
Completion date	01/05/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	11 Years
Upper age limit	14 Years
Sex	Not Specified
Target number of participants	140 Study group; 140 Control Group (Wait list)
Total final enrolment	325
Key inclusion criteria	1. Aged between 11 and 14 2. Score above cut-off point on Nepal-specific screener for general psychosocial well-being (a screening tool currently in clinical use)
Key exclusion criteria	1. Children scoring under cut-off score 2. Children in need of individual/specialised service
Date of first enrolment	01/01/2007
Date of final enrolment	01/05/2007

Locations

Countries of recruitment

Nepal

Study participating centre

Lazimpat

Kathmandu
PO 8974 CPC 612
Nepal

Sponsor information

Save the Children USA (Nepal office)
Charity

Maharajgunj
Kathmandu
PO Box 2218
Nepal

Phone	+977 (0)1 4412598
Email	tclawson@savechildren.org.np
Website	http://www.savethechildren.org/countries/asia/nepal.html
"ROR"	https://ror.org/036jr6x18

Funders

Funder type

Charity

Save the Children USA (Nepal office)

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	01/07/2010	14/01/2021	Yes	No

Editorial Notes

14/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.