Clinical trial NCT04091633: School Health Implementation Network: Eastern Mediterranean
Official title: Evaluating the Effectiveness of Technology Assisted School Mental Health Program to Improve Socio-emotional Wellbeing of School Going Children in Public Schools of Rural Pakistan: A Cluster Randomized Controlled Trial (cRCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavioral Symptoms
Behavioral Problem
Emotional Problem
Emotional Stress
ADHD
Emotional Disorder
Depression, Anxiety
Conduct Disorder
Emotional Trauma
Lead sponsor: Human Development Research Foundation, Pakistan
Sponsor class: OTHER
Collaborators: name: University of Liverpool
name: University of Washington
name: Pakistan Ministry of Health
name: World Health Organization
name: Institute of Psychiatry, WHO Collaborating Center for Mental Health, Rawalpindi
name: National Institute of Mental Health (NIMH)
name: Liverpool School of Tropical Medicine
name: Harvard University
First posted: 2019-09-17
Enrollment: 971
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind, two arm, cluster randomized controlled trial
Primary purpose: PREVENTION

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.


Eligibility criteria: Eligibility Criteria for Children

Inclusion criteria for children:

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).

Exclusion criteria for children:

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.

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.

Primary outcomes:
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Baseline and at 9 months after commencing intervention delivery
Secondary outcomes:
measure: Externalizing and internalizing problems on parent-rated SDQ
timeFrame: Baseline and at 9 months after commencing intervention delivery
measure: Child's psycho-social well being and functioning (PSYCHLOPS)-Kids
timeFrame: Baseline, at 3 and 9 months after commencing intervention delivery
measure: Pediatric Quality of Life (Peds-QL)
timeFrame: Baseline and at 9 months after commencing intervention delivery
measure: WHO-Disability Assessment Scale Child Version (WHO-DAS Child 12)
timeFrame: Baseline and at 9 months after commencing intervention delivery
measure: Academic performance and absenteeism
timeFrame: Baseline and at 9 months after commencing intervention delivery
measure: Teachers' Sense of Efficacy Scale (TSES)
timeFrame: Baseline, at 3 and 9 months after commencing intervention delivery
measure: Self-Reporting Questionnaire (SRQ)
timeFrame: Baseline, at 3 and 9 months after commencing intervention delivery
measure: Parent Teacher Involvement Questionnaire (PTIQ)
timeFrame: Baseline and at 9 months after commencing intervention delivery
measure: Psycho-Social Environment (PSE) Profile
timeFrame: Baseline and at 9 months after commencing intervention delivery
measure: Determinants of Implementation Behavior Questionnaire (DIBQ)
timeFrame: At 3 months after commencing intervention delivery
measure: Slef-rated Paediatric Self-Stigmatization Scale (PaedS)
timeFrame: Baseline and at 9 months after commencing intervention delivery
measure: Client Services Receipt Inventory
timeFrame: Baseline and at 9 months after commencing intervention delivery
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Human Development Research Foundation
Study officials:
affiliation: University of Liverpool
name: Atif Rahman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington, Seattle, USA
name: Lawrence Wissow, MD
role: PRINCIPAL_INVESTIGATOR
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