Condition category
Mental and Behavioural Disorders
Date applied
06/12/2006
Date assigned
10/01/2007
Last edited
10/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Mark Jordans

ORCID ID

Contact details

Lazimpat
Kathmandu
PO 8974 CPC 612
Nepal
+977 (0)1 4428439
mjordans@healthnettpo.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Classroom/Camp/Community-Based Intervention (CBI) will improve daily functioning and reduce psychological distress.

Ethics approval

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.

Study design

Randomised Controlled Trial (cluster randomisation)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

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 children’s 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/2007

Overall trial end date

01/05/2007

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

140 Study group; 140 Control Group (Wait list)

Participant exclusion criteria

1. Children scoring under cut-off score
2. Children in need of individual/specialised service

Recruitment start date

01/01/2007

Recruitment end date

01/05/2007

Locations

Countries of recruitment

Nepal

Trial participating centre

Lazimpat
Kathmandu
PO 8974 CPC 612
Nepal

Sponsor information

Organisation

Save the Children USA (Nepal office)

Sponsor details

Maharajgunj
Kathmandu
PO Box 2218
Nepal
+977 (0)1 4412598
tclawson@savechildren.org.np

Sponsor type

Charity

Website

http://www.savethechildren.org/countries/asia/nepal.html

Funders

Funder type

Charity

Funder name

Save the Children USA (Nepal office)

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes