ISRCTN ISRCTN83632872
DOI https://doi.org/10.1186/ISRCTN83632872
Secondary identifying numbers CRAS01092021
Submission date
22/11/2024
Registration date
27/11/2024
Last edited
27/11/2024
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
Record updated in last year

Plain English summary of protocol

Background and study aims
Growing evidence indicates that school-based psychosocial interventions may help address the mental health gap in low- and middle-income countries, including conflict and crisis contexts. This study aims to compare a psychosocial intervention with usual teaching in Afghanistan. A two-arm cluster-randomised trial was implemented in 83 rural primary schools within three provinces of Afghanistan. This study will assess whether school-based interventions delivered by trained field education officers can effectively promote child mental health in conflict and crisis settings and have great potential for scalability.

Who can participate?
All children in grades 3 to 5, their teacher and one adult family member (mother or father, older sibling) at enrolment.

What does the study involve?
Schools were randomly assigned (1:1) to one of two groups: a psychosocial intervention group composed of whole classes with a one-week classroom-based teacher and children component and a one-day family engagement component; and, a control group. Children, teachers and parents were surveyed at baseline and four months postintervention.

What are the possible benefits and risks of participating?
There was the possible benefits to improve learning skills both academic and non academic (lifeskills) learning skills. There was no risk in participating in this research.

Where is the study run from?
Washington University in St. Louis, USA

When is the study starting and how long is it expected to run for?
August 2021 to December 2023

Who is funding the study?
1. Economic Social Research Council (ESRC)
2. Norwegian Development Agency

Who is the main contact?
Dr Jean-Francois Trani, jtrani@wustl.edu

Study website

Contact information

Prof Jean-Francois Trani
Public, Scientific, Principal Investigator

Brown School, Washington University, One Brookings drive
St Louis
63130
United States of America

ORCiD logoORCID ID 0000-0002-9187-0946
Phone +13149359277
Email jtrani@wustl.edu

Study information

Study designTwo-arm cluster-randomized trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)School
Study typeQuality of life
Participant information sheet Not available in web format please use contact details to request a participant information sheet
Scientific titleClassroom-based psychosocial randomised trial in primary schools of Afghanistan
Study acronymCRAS
Study objectivesSchool based psycho-social intervention to improve child mental well-being and resilience in Afghanistan
Ethics approval(s)

1. Approved 30/08/2021, Human Research Protection Office Washington University in St Louis (One Brookings drive, St Louis, 63130, United States of America; +1 314-747-6800; ehiggs@wustl.edu), ref: 201712020

2. Approved 17/09/2022, Norwegian Afghanistan Committee Board (Kolstadgata 1, Oslo, 0652, Norway; +47 994 09 159; t.watterdal@nacaf.org), ref: -

Health condition(s) or problem(s) studiedAnxiety and depression
InterventionThis study is a two-arm cluster-randomised trial implemented in 83 rural primary schools within three provinces of Afghanistan. Eligible participants were all children in grades 3 to 5, their teacher and one adult family member (mother or father, older sibling) at enrolment.

All primary schools in each province were first enumerated, either governmental or community-based schools, receiving some support from the two NGOs and having at least one classroom of grades 3 through 5. Among 292 schools across these three provinces, a random number generator was used to select schools within each province (83 schools). To avoid the risk of contamination, sampling without replacement was used to ensure that only one school was selected per village. Schools within each province were randomly assigned in a 1:1 ratio to one of two groups (40 to the intervention group, and the remaining to the control group). Within each school, whole grades 3 through 5 classes were selected when the total number was below 20 children per class. In classes with more than 20 children, 20 children were randomly selected as participants. From a total cohort of 3254 children, 1522 children were enrolled in the intervention group and 1732 in the control group. Children, their teacher (one per class), and their parents formed this study’s participants.

Schools were randomly assigned (1:1) to one of two groups, with the intervention group consisting of (1) a week-long classroom-based training with teachers and children together, and (2) a one-day training with parents using a culturally adapted version of the “A hopeful, healthy, and happy living and learning toolkit” developed by the International Federation of the Red Cross and Red Crescent Societies in response to the COVID-19 pandemic, and a control group. The final program for teachers and children was delivered in Dari and Pashto, composed of 42 activities consisting of a week of training including reflective exercises, didactic short lectures on lessons learned, drama, games, mindfulness, and breathing exercises. The parent component of the intervention was delivered in Dari and Pashto and consisted of one day spent on a series of activities aiming at promoting psycho-social well-being at home after cultural adaptation of the parent-caregiver toolkit by the same team.
Intervention typeBehavioural
Primary outcome measureThe following primary outcome measures were assessed at baseline and endline after 4 months:
1. Child anxiety and depression measured using the simplified revised child anxiety and depression scale
2. Life skills core domains measured using the multidimensional scale of life skills in late childhood
3. Self-efficacy measured using the self-efficacy questionnaire for children
4. Resilience measured using the child and youth resilience measure
5. School-based discrimination measured using the discrimination scale developed for the Maryland adolescent development in context study
6. Stigma measured using the discrimination and stigma scale
Secondary outcome measuresProficiency in reading and mathematical literacy measured using the Monitoring Education Development in Afghanistan (MED-A) framework developed by the Australian Council for Educational Research (ACER 2013) that includes comprehensive and context-appropriate definitions of “literacy score” to evaluate reading and writing in Dari/Pashto, as well as mathematics at baseline and endline after 4 months
Overall study start date30/08/2021
Completion date30/12/2023

Eligibility

Participant type(s)Learner/student
Age groupChild
Lower age limit8 Years
Upper age limit14 Years
SexBoth
Target number of participants20% of students of grades 3 and 5 in each of the 83 randomly selected schools
Total final enrolment2592
Key inclusion criteriaEnrolled in grade 3 or 5 in participating schools
Key exclusion criteriaChildren in 1, 2, 4 or 6 grade
Date of first enrolment01/05/2022
Date of final enrolment30/03/2023

Locations

Countries of recruitment

  • Afghanistan
  • France

Study participating centres

Aanj Girls’ High School
-
-
-
Afghanistan
Dasht E Badara Primary School
-
-
-
Afghanistan
Etarchi Mixed High School
-
-
-
Afghanistan
Gulaki primary school
-
-
-
Afghanistan
Mardara Primary School
-
-
-
Afghanistan
Mashhad Primary School
-
-
-
Afghanistan
Nayeb Saray Gharbi Primary School
-
-
-
Afghanistan
Said Abdul Karim Boys High School
-
-
-
Afghanistan
Sayed Mohammad Dehqan Primary School
-
-
-
Afghanistan
Shatak Primary School
-
-
-
Afghanistan
Wakhshi Primary School
-
-
-
Afghanistan
Abdul Qadir Hanif mixed school
-
-
-
France

Sponsor information

Washington University in St. Louis
University/education

One Brookings Drive
St Louis
63130
United States of America

Phone +1314-935-6600
Email brownschool@wustl.edu
Website https://brownschool.washu.edu/contact-us/
ROR logo "ROR" https://ror.org/01yc7t268

Funders

Funder type

Research council

Economic and Social Research Council
Government organisation / National government
Alternative name(s)
ESRC
Location
United Kingdom
Norwegain Development Agency

No information available

Results and Publications

Intention to publish date31/03/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
Publication and dissemination planPlanned publication in peer-reviewed journals. Two papers are planned, one looking at the effect of the intervention on main outcomes and one looking at factors influencing child wellbeing from a system dynamics perspective
IPD sharing planThe datasets generated and analysed during the current study will be stored in a public available repository at the UK Data Service: http://reshare.ukdataservice.ac.uk/

• The type of data stored: .csv data
• Timing for availability: end of 2024
• Whether consent from participants was required and obtained: All participants provided written (or witnessed, if they were unable to read and write) informed consent.
• Comments on data anonymization: The data is stored encrypted in the database without any name or other possibility of individual identification. The database is protected by a password. All unique identifiers have been be deleted once the database is complete. The database is totally anonymous. The only copies of the database is stored on the encrypted cloud of the Brown School at Washington University in St Louis
• Any ethical or legal restrictions: none
• Any additional comments: none

Editorial Notes

22/11/2024: Study's existence confirmed by the Washington University in St. Louis Institutional Review Board.