School Health Implementation Network: Eastern Mediterranean
Condition: Behavioral Symptoms; Behavioral Problem; Emotional Problem; Emotional Stress; ADHD; Emotional Disorder; Depression, Anxiety; Conduct Disorder; Emotional Trauma
MeSH terms: Behavioral Symptoms; Conduct Disorder; Problem Behavior
Study type: Interventional

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.
    


Intervention name(s): WHO School Mental Health Program; Enhanced School Mental Health Program (eSMHP)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blind, two arm, cluster randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention