School Health Implementation Network: Eastern Mediterranean

NCT04091633 | Completed DMC

• 2 other identifiers: SHINE cRCTU19MH109998-01
• Study Type: interventional
• Target: 971
• Locations: 1 country
• Sites: 1

Brief Summary

Background 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.

Conditions

Behavioral Symptoms; Behavioral Problem; Emotional Problem; Emotional Stress; ADHD; Emotional Disorder; Depression, Anxiety; Conduct Disorder; Emotional Trauma

Outcome Measures

Primary Outcomes (1)

• Strengths and Difficulties Questionnaire (SDQ)

  The change in total difficulties scores of children will be measured at 9 months after commencing intervention delivery using the parent-rated Strengths and Difficulties Questionnaire (SDQ) . SDQ has 25 items and consists of sub-scales to measure emotional symptoms, conduct problems, hyperactivity/inattention, peer problems and prosocial behavior. Items are rated on a three-point Likert scale (0= not true, 1= somewhat true, 2=certainly true). Total difficulty score is calculated by summing the responses of each item in all domains except pro-social behavior items. SDQ has been culturally adapted and validated in Pakistan

  Baseline and at 9 months after commencing intervention delivery

Secondary Outcomes (12)

• Externalizing and internalizing problems on parent-rated SDQ

  Baseline and at 9 months after commencing intervention delivery

• Child's psycho-social well being and functioning (PSYCHLOPS)-Kids

  Baseline, at 3 and 9 months after commencing intervention delivery

• Pediatric Quality of Life (Peds-QL)

  Baseline and at 9 months after commencing intervention delivery

• WHO-Disability Assessment Scale Child Version (WHO-DAS Child 12)

  Baseline and at 9 months after commencing intervention delivery

• Academic performance and absenteeism

  Baseline and at 9 months after commencing intervention delivery

Study Arms (2)

School Mental Health Program-Conventional (cSMHP)

ACTIVE COMPARATOR

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.

Behavioral: WHO School Mental Health Program

Enhanced-School Mental Health Program (eSMHP)

EXPERIMENTAL

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.

Behavioral: Enhanced School Mental Health Program (eSMHP)

Interventions

WHO School Mental Health Program BEHAVIORAL

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.

School Mental Health Program-Conventional (cSMHP)

Enhanced School Mental Health Program (eSMHP) BEHAVIORAL

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.

Enhanced-School Mental Health Program (eSMHP)

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children meeting the following criteria will be included in the study; i. Aged 8-13 years living with parents/primary caregivers ii. Written parent/primary caregiver informed consent or witnessed consent (in case the parent is unable to read and write, the informed consent will be obtained from both parent and witness) and child assent for participation in the study.
• iii. Screen positive on teacher-rated SDQ (total difficulties score \> 12) and parent-rated SDQ (total difficulties score ≥ 14).

You may not qualify if:

• i. Children at high risk of abuse or harm to self or others as reported by the students themselves, teachers or parents/primary caregivers, or identified by the trained assessment team during screening.
• 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.

Sponsors & Collaborators

• Human Development Research Foundation, Pakistan: lead
• University of Liverpool: collaborator
• University of Washington: collaborator
• Pakistan Ministry of Health: collaborator
• World Health Organization: collaborator
• Institute of Psychiatry, WHO Collaborating Center for Mental Health, Rawalpindi: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Liverpool School of Tropical Medicine: collaborator
• Harvard University: collaborator

Study Sites (1)

Human Development Research Foundation

Islamabad, Pakistan

Location

Related Publications (10)

• 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.

  PMID: 9255702 BACKGROUND

• 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.

  PMID: 32677230 BACKGROUND

• 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.

  PMID: 8952375 BACKGROUND

• 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.

  PMID: 10024117 BACKGROUND

• Tschannen-Moran, M. and A.W. Hoy, Teacher efficacy: Capturing an elusive construct. Teaching and teacher education, 2001. 17(7): p. 783-805.

  BACKGROUND

• Beusenberg, M., J.H. Orley, and W.H. Organization, A User's guide to the self reporting questionnaire (SRQ. 1994, Geneva: World Health Organization

  BACKGROUND

• Organization, W.H., Creating an environment for emotional and social well-being: an important responsibility of a health promoting and child-friendly school. 2003

  BACKGROUND

• 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.

  PMID: 24641907 BACKGROUND

• 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.

  PMID: 19485644 BACKGROUND

• 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.

  PMID: 32838678 DERIVED

MeSH Terms

Conditions

Behavioral Symptoms; Problem Behavior; Stress, Psychological; Attention Deficit Disorder with Hyperactivity; Depression; Anxiety Disorders; Conduct Disorder

Condition Hierarchy (Ancestors)

Behavior; Child Behavior; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Atif Rahman, PhD

  University of Liverpool

  PRINCIPAL INVESTIGATOR

• Lawrence Wissow, MD

  University of Washington, Seattle, USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study investigators and outcome assessors will be blind to the allocations status of participants. To ensure blinding, participants will be instructed to not disclose their allocation during assessment. Fidelity of masking will be ensured by having assessors guess the allocation status of participants at the end of assessments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blind, two arm, cluster randomized controlled trial

Study Record Dates

• First Submitted: September 14, 2019
• First Posted: September 17, 2019
• Study Start: October 7, 2019
• Primary Completion: June 30, 2021
• Study Completion: April 22, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: August, 2021

Locations

PA (1)