School Health Implementation Network: Eastern Mediterranean
NCT ID: NCT04091633
Last Updated: 2022-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
971 participants
INTERVENTIONAL
2019-10-07
2022-04-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
An estimated 10-20% of children globally are affected by a mental health problem. Child mental health has been identified as a priority issue by the World Health Organization's Eastern Mediterranean Regional Office (WHO EMRO). Following consultations with international and regional experts and stakeholders, WHO EMRO developed an evidence-based School Mental Health Program (SMHP), endorsed by WHO EMRO member countries, including Pakistan. The federal and provincial health departments in Pakistan made recommendations for a phased implementation of the SMHP in a pilot district. In the formative phase of this program, a number of implementation challenges were identified by the stakeholders. Broadly, these included the need to operationalize and adapt the existing components of the intervention to the local context and to develop sustainable mechanisms for delivery of quality training and supervision.
Informed by the results of a formative phase investigations, the SHINE scale-up research team adapted the SMHP (henceforth called Conventional SMHP or cSMHP) to address these implementation challenges. The enhanced version of the intervention is called Enhanced School Mental Health Program (eSMHP). Enhancements to cSMHP have occurred at two levels: A) Content enhancements, such as a collaborative care model for engaging parents/primary caregivers, strategies for teacher's wellbeing, and adaptation and operationalization of particular clinical intervention strategies and B) Technological enhancements which include adaptation of the training manual for delivery using an online training platform, and a 'Chat-bot' to aid the implementation of intervention strategies in classroom settings.
Objectives
The primary objective of the study is to evaluate the effectiveness of eSMHP in reducing socio-emotional difficulties in school-going children, aged 8-13, compared to cSMHP in Gujar Khan, a rural sub-district of Rawalpindi, Pakistan.
The secondary objectives are to compare the cost-effectiveness, acceptability, adoption, appropriateness (including cultural appropriateness), feasibility, penetration and sustainability of scaled-up implementation of eSMHP and cSMHP. It is hypothesized that eSMHP will prove to be both more effective and more scalable than cSMHP.
Study population
The research is embedded within the phased district level implementation of the cSMHP in Rawalpindi, Pakistan. The study population will consist of children of both genders, aged 8-13 (n=960) with socio-emotional difficulties, studying in rural public schools of sub-district Gujar Khan in Rawalpindi.
Design
The proposed study design is a cluster randomized controlled trial (cRCT), embedded within the conventional implementation of the SMHP. Following relevant ethics committees and regulatory approvals, 80 eligible schools, stratified by gender, will be randomized into intervention and control arms with a 1:1 allocation ratio. Following informed consent from the parent/ primary caregiver, children will be screened for socio-emotional difficulties using Strengths and Difficulties Questionnaire (SDQ). 960 children scoring \> 12 on the teacher-rated SDQ total difficulty scores and \> 14 on the parent-rated SDQ total difficulty scores will be recruited and equally randomized into intervention and control arms (480 in each arm).
Teachers in the intervention arm will receive training in eSMHP, whereas teachers in the active control will be trained in cSMHP. Trained teachers will deliver the program to children in their respective arms.
Outcome measures
Primary Outcome: The primary outcome is reduction in socio-emotional total difficulties scores, measured with the parent-rated SDQ, 9 months after commencing intervention delivery.
Secondary Outcomes: Implementation data on acceptability, adoption, appropriateness (including cultural appropriateness), feasibility, penetration and sustainability outcomes will be collected from children, parents/primary caregivers, head teachers and teachers. In addition, data will be collected on self-reported Psychological Outcome Profiles (PSYCHLOPS)-KIDS to measure progress on psycho-social problems and wellbeing; annual academic performance; classroom absenteeism, stigmatizing experiences and parent-teacher interaction. Data on teachers' sense of efficacy and subjective well-being, and on the schools' psychosocial environment profile will be collected. All secondary outcome data will be collected at baseline and 9 months after commencing intervention delivery.
Outcomes will be analyzed on an intention to treat basis. The role of various factors as potential mediators and moderators eSMHP effectiveness will be explored.
Cost-effectiveness evaluation of SMHP shall be evaluated in terms of costs associated with implementation of eSMHP compared with cSMHP.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Improvement of Mental Health in Adolescents Using E-health Interventions
NCT05865834
Impact of a Classroom-based Sensitization Intervention on Demand for Mental Health Care Among Adolescents in India
NCT03633916
Effectiveness of School Based Intervention for Promoting Mental Health Literacy Among Teachers
NCT02937714
Effects of Parent-Adolescent Joint Interventions for Adolescents With Adverse Childhood Experiences
NCT06619821
Community Based Psychological Intervention for Persons Living with Disabilities
NCT04981522
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Fidelity of masking will be ensured by having assessors guess the allocation status of participants at the end of assessments.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
School Mental Health Program-Conventional (cSMHP)
The teachers of schools randomized to control arm will receive training in World Health Organization (WHO) School Mental Health Program (SMHP) by mental health experts at WHO collaborating center for mental health research and training, Institute of Psychiatry. The training of teachers will consist of a mix of both didactic and interactive training methodologies in the form of a workshop. The workshop will consist of lectures/presentations, incorporating group discussions/activities. Through didactic methods, teachers will be taught basic theoretical knowledge related to mental health in schools. Training will be followed by monthly supervision meeting of teachers for 9-months.
WHO School Mental Health Program
World Health Organization (WHO) School Mental Health Program (SMHP) is a manual based multi-component, multi-tiered and evidence-informed intervention for common mental health problems in school going children. SMHP is designed to be introduced into the normal classroom and school setting by trained teachers. The intervention has a universal component which takes a whole school approach that aims to promote mental health among all school children. It includes basic counseling skills for teachers, core values of mental health promoting schools and other health promoting efforts that impact upon mental health and can be administered to all students in school and classroom settings. The manual also contains targeted intervention strategies on anxiety, separation anxiety/ school refusal, post-trauma, depression, suicide, ADHD, autism, psychosis, conduct problems and substance use problems that can be implemented by teachers in classroom settings.
Enhanced-School Mental Health Program (eSMHP)
The teachers of schools randomized to intervention arm will receive online training in adapted version of School Mental Health Program. The online training in adapted School Mental Health Program consists of 4-5 hour, self-paced online training course for teachers. The teachers will register themselves in the online course in the form of a group of 4-5 teachers from each school. The teachers will complete the online training course in a group, with interactive group activities and role plays. Progress to the next module in the online training is conditional upon completion of post-module mental health literacy quiz. A certificate of training completion in adapted SMHP shall be awarded to those teachers who complete the post-test. Teachers will be supported online and in-person by the trainers who are trained in SMHP in monthly supervision meeting of teachers for 9-months.
Enhanced School Mental Health Program (eSMHP)
Informed by the results of pilot implementation, a number of content and delivery adaptations have been made to the School Mental Health Program (SMHP) to address the implementation challenges to scale-up of program in Pakistan. The adapted version of the intervention is called Enhanced School Mental Health Program (eSMHP). Enhancements to conventional SMHP have occurred at two levels: A) Content enhancements, such as a collaborative care model for engaging parents/primary caregivers, strategies for teacher's well-being, and adaptation and operationalization of particular clinical intervention strategies and B) Technological enhancements which include adaptation of the training manual for delivery using an online training platform, and a 'Chat-bot' to aid the implementation of intervention strategies in classroom settings.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
WHO School Mental Health Program
World Health Organization (WHO) School Mental Health Program (SMHP) is a manual based multi-component, multi-tiered and evidence-informed intervention for common mental health problems in school going children. SMHP is designed to be introduced into the normal classroom and school setting by trained teachers. The intervention has a universal component which takes a whole school approach that aims to promote mental health among all school children. It includes basic counseling skills for teachers, core values of mental health promoting schools and other health promoting efforts that impact upon mental health and can be administered to all students in school and classroom settings. The manual also contains targeted intervention strategies on anxiety, separation anxiety/ school refusal, post-trauma, depression, suicide, ADHD, autism, psychosis, conduct problems and substance use problems that can be implemented by teachers in classroom settings.
Enhanced School Mental Health Program (eSMHP)
Informed by the results of pilot implementation, a number of content and delivery adaptations have been made to the School Mental Health Program (SMHP) to address the implementation challenges to scale-up of program in Pakistan. The adapted version of the intervention is called Enhanced School Mental Health Program (eSMHP). Enhancements to conventional SMHP have occurred at two levels: A) Content enhancements, such as a collaborative care model for engaging parents/primary caregivers, strategies for teacher's well-being, and adaptation and operationalization of particular clinical intervention strategies and B) Technological enhancements which include adaptation of the training manual for delivery using an online training platform, and a 'Chat-bot' to aid the implementation of intervention strategies in classroom settings.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
iii. Screen positive on teacher-rated SDQ (total difficulties score \> 12) and parent-rated SDQ (total difficulties score ≥ 14).
Exclusion Criteria
ii. Children who require immediate or on-going in-patient medical or psychiatric care, as reported by student themselves or teachers or parents/primary caregivers or identified by the trained assessment team during screening.
iii. Children with deafness, blindness and speech difficulties or with developmental disorders as defined by the WHO mhGAP intervention guide identified by the trained assessment team during screening.
Exclusion from the evaluation will not impact the care received by the school children as all children studying in public schools will receive intervention as part of routine implementation of WHO SMHP.
8 Years
13 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Liverpool
OTHER
University of Washington
OTHER
Pakistan Ministry of Health
OTHER_GOV
World Health Organization
OTHER
Institute of Psychiatry, WHO Collaborating Center for Mental Health, Rawalpindi
UNKNOWN
National Institute of Mental Health (NIMH)
NIH
Liverpool School of Tropical Medicine
OTHER
Harvard University
OTHER
Human Development Research Foundation, Pakistan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Atif Rahman, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Liverpool
Lawrence Wissow, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington, Seattle, USA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Human Development Research Foundation
Islamabad, , Pakistan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.
Godfrey E, Aubrey M, Crockford S, Haythorne D, Kordowicz M, Ashworth M. The development and testing of PSYCHLOPS Kids: a new child-centred outcome measure. Child Adolesc Ment Health. 2019 Feb;24(1):54-65. doi: 10.1111/camh.12271. Epub 2018 Mar 24.
Janca A, Kastrup M, Katschnig H, Lopez-Ibor JJ Jr, Mezzich JE, Sartorius N. The World Health Organization Short Disability Assessment Schedule (WHO DAS-S): a tool for the assessment of difficulties in selected areas of functioning of patients with mental disorders. Soc Psychiatry Psychiatr Epidemiol. 1996 Nov;31(6):349-54. doi: 10.1007/BF00783424.
Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39. doi: 10.1097/00005650-199902000-00003.
Tschannen-Moran, M. and A.W. Hoy, Teacher efficacy: Capturing an elusive construct. Teaching and teacher education, 2001. 17(7): p. 783-805.
Beusenberg, M., J.H. Orley, and W.H. Organization, A User's guide to the self reporting questionnaire (SRQ. 1994, Geneva: World Health Organization
Organization, W.H., Creating an environment for emotional and social well-being: an important responsibility of a health promoting and child-friendly school. 2003
Huijg JM, Gebhardt WA, Dusseldorp E, Verheijden MW, van der Zouwe N, Middelkoop BJ, Crone MR. Measuring determinants of implementation behavior: psychometric properties of a questionnaire based on the theoretical domains framework. Implement Sci. 2014 Mar 19;9:33. doi: 10.1186/1748-5908-9-33.
Moses T. Stigma and self-concept among adolescents receiving mental health treatment. Am J Orthopsychiatry. 2009 Apr;79(2):261-74. doi: 10.1037/a0015696.
Hamdani SU; Zill-e-Huma; Warraitch A, Suleman N, Muzzafar N, Minhas FA; F.R.C.Psych; Nizami AT; F.C.P.S.; Sikander S; F.C.P.S.; Pringle B, Hamoda HM, Wang D, Rahman A, Wissow LS. Technology-Assisted Teachers' Training to Promote Socioemotional Well-Being of Children in Public Schools in Rural Pakistan. Psychiatr Serv. 2021 Jan 1;72(1):69-76. doi: 10.1176/appi.ps.202000005. Epub 2020 Aug 25.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SHINE cRCT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.