Behavioral SymptomsSHINENCT04091633
School Health Implementation Network: Eastern Mediterranean
A study testing WHO School Mental Health Program and Enhanced School Mental Health Program (eSMHP) in people with Behavioral Symptoms and Behavioral Problem, run by Human Development Research Foundation, Pakistan at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Behavioral Symptoms, Behavioral Problem, Emotional Problem
- What is being tested?
- WHO School Mental Health Program and Enhanced School Mental Health Program (eSMHP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 971 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Oct 2019to 22 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- Screen positive on teacher-rated SDQ (total difficulties score > 12) and parent-rated SDQ (total difficulties score ≥ 14).
Who cannot join
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read more
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
- Being tested
- WHO School Mental Health Program, Enhanced School Mental Health Program (eSMHP)
- Medical subject headings
- Behavioral Symptoms, Problem Behavior, Stress, Psychological, Attention Deficit Disorder with Hyperactivity, Depression, Anxiety Disorders, Conduct Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHO School Mental Health ProgramBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Enhanced School Mental Health Program (eSMHP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and at 9 months after commencing intervention delivery
Secondary outcomes (12)
Externalizing and internalizing problems on parent-rated SDQ
Externalizing problems in children will be measured at 9 months after commencing intervention delivery, by combining conduct and hyperactivity sub-scales scores on parent-rated SDQ. Internalizing problems in children will be measured at 6 months after commencing intervention delivery, by combining emotional and peer problems subscales on parent-rated SDQ.
Measured: Baseline and at 9 months after commencing intervention delivery
Child's psycho-social well being and functioning (PSYCHLOPS)-Kids
Child's insight into his/her problems and wellbeing would be measured using the self-administered PSYCHLOPS Kids. The outcome measure assesses three domains, including problems, functioning and well-being. PSYCHLOPS KIDS has three questionnaire forms i.e. pre-therapy, during therapy and post therapy version. Some of the items are qualitative and provide additional information about child's problem, functioning and wellbeing, but are not provided a score. Other items are rated on 0-4 scale. The maximum score for each question is 4 (scored 0-4). PSYCHLOPS pre, during and post intervention versions would be administered by assessment team at baseline, and at 9 months after commencing intervention delivery, respectively.
Measured: Baseline, at 3 and 9 months after commencing intervention delivery
Pediatric Quality of Life (Peds-QL)
Child's health related quality of life during past month will be measured by parent-rated Pediatric Quality of Life (Peds-QL). The Peds-QL is 23 item impact module scale that encompasses 4 sub-scales namely physical functioning, emotional functioning, social functioning and school functioning . Items are rated on a 4-point Likert scale (1 = no problem to 4 = almost always a problem). Items are then reverse-scored and linearly transformed to a 0-100, so that higher scores indicate better quality of life. This tool yields a total score (all 23 items), physical health Summary score (8 items), Psychosocial Health Summary score (10 items) and School Functioning score (5 items).
Measured: Baseline and at 9 months after commencing intervention delivery
WHO-Disability Assessment Scale Child Version (WHO-DAS Child 12)
WHODAS Child 12 is used to measure individuals' difficulties due to mental health problems across six domains including cognition, mobility, self-care, getting along, life activities, and participation, during the last 30 days. It has 12-items which are rated on a scale of 0 to 4, with summed total scores ranging from 0 to 48. The parent-rated WHO-DAS 12 - Child Version will be used to measure child's functioning at baseline and 9 months' after commencing intervention delivery.
Measured: Baseline and at 9 months after commencing intervention delivery
Academic performance and absenteeism
The record of attendance and academic grades will be obtained from the school records at 9 months after commencing intervention delivery
Measured: Baseline and at 9 months after commencing intervention delivery
Teachers' Sense of Efficacy Scale (TSES)
The 12 item teachers' sense of efficacy scale will be used to assess teacher's beliefs about his or her capabilities in enhancing students' learning and ability to get through to students who are difficult or unmotivated. The scale measures teacher's sense of efficacy on three subscales namely, instructional strategies, student engagement and classroom management. The items are rated on 9 points Likert scale ranging from (1) 'None at all' to (9) 'A great deal'.
Measured: Baseline, at 3 and 9 months after commencing intervention delivery
Self-Reporting Questionnaire (SRQ)
The Self-Reporting Questionnaire (SRQ) is a 20-item self-report measure to detect non-specific psychological distress, developed by the World Health Organization. Psychological distress is represented by subscales of physical symptoms and emotional symptoms . The SRQ items are scored 0 or 1. A score of 1 indicates the presence of symptoms of psychological distress during past month and a score of 0 indicates absence of symptoms. The maximum score indicates presence of higher psychological distress.
Measured: Baseline, at 3 and 9 months after commencing intervention delivery
Parent Teacher Involvement Questionnaire (PTIQ)
The Parent Teacher Involvement Questionnaire (PTIQ) is used to measure the frequency and quality of parental involvement in children's educational progress in school and at home. The parent version of PTIQ has 26 items while the teacher version has 21 items. The four subscales of parent-rated PTIQ include frequency of contact between parents/primary caregivers and teachers, quality of parent teacher relationship, parent's/primary caregivers' volunteering and involvement of parents/primary caregivers, parent's/primary caregivers' endorsement of their child's school, while the three subscales of teacher-rated PTIQ include quality and frequency of contact between parents/primary caregivers and teacher, parent's/primary caregivers volunteering and involvement of parents/primary caregivers, parent's/primary caregivers' endorsement of their child's school . It's a 5-point Likert scale with more than one type of response options. Higher scores indicate more parental involvement.
Measured: Baseline and at 9 months after commencing intervention delivery
Psycho-Social Environment (PSE) Profile
Psycho-Social Environment (PSE) Profile will be administered with head teachers and teachers to identify school's capacity to create healthy psycho-social environment for its staff, teachers and students. The Psychosocial Environment Profile is a 98 item scale developed by the World Health Organization to evaluate the extent to which a school's environment contributes to the social and emotional well-being of its students and staff. Each question is scored on a scale from 1 to 4, with 1 representing the lowest and 4 the highest rating of social and emotional support.
Measured: Baseline and at 9 months after commencing intervention delivery
Determinants of Implementation Behavior Questionnaire (DIBQ)
DIBQ will be used to measure the change in teachers' behavior to implement the SMHP in school and classroom settings. It is a tool based on 'The Theoretical Domains Framework (TDF)' to measure behavior change of providers. DIBQ will be used to explore the determinants that inhibit or promote the implementation of evidence-based intervention strategies by teachers. An adapted version of DIBQ, based on 18 domains of TDF and consisting of 93 items will be used to assess the change in teachers' behavior regarding implementation of SMHP. Responses on DIBQ are scored from 1 'strongly disagree' to 7 'strongly agree'. Total sum for each domain is calculated and divided by maximum score for the given domain.
Measured: At 3 months after commencing intervention delivery
Slef-rated Paediatric Self-Stigmatization Scale (PaedS)
The self-stigma subscale of the PaedS will be used to measure stigma in children and adolescents .It has 5 items that measure sense of shame, embarrassment, and worry about others' responses towards mental health problems. The items are rated on 4 point likert scale, where higher scores indicate greater stigmatization.
Measured: Baseline and at 9 months after commencing intervention delivery
Client Services Receipt Inventory
Service use and out-of-pocket expenditure of the research participants (costs for: seeing a doctor or other health care providers; admission to hospital, medicines, tests and extra help at home needed) will be collected using a validated version of the Client Services Received Inventory (CSRI). It has previously been adapted for childhood developmental disorders and autism in study settings.
Measured: Baseline and at 9 months after commencing intervention delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start7 Oct 2019
- Primary completion30 Jun 2021
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Behavioral SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blind, two arm, cluster randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 971 participants (actual)
Sponsor and investigators
- Lead sponsor
- Human Development Research Foundation, Pakistan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool, University of Washington, Pakistan Ministry of Health, World Health Organization, National Institute of Mental Health (NIMH), Liverpool School of Tropical Medicine, Harvard University
- Responsible party
- Sponsor
- Investigators
- Atif Rahman, PhD, Principal investigator, University of LiverpoolLawrence Wissow, MD, Principal investigator, University of Washington, Seattle, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091633
- Sponsor's protocol ID
- SHINE cRCT
- Other IDs
- U19MH109998-01
- Acronym
- SHINE
- Status last verified
- Aug 2022
- First submitted
- 14 Sep 2019
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In compliance with the data sharing agreement, the unidentifiable data set will be periodically submitted to the online NIMH data repository- National Database for Clinical Trials Related to Mental Illness (NDCT).
Publications
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.
PubMed 9255702Godfrey 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.
PubMed 32677230Janca 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.
PubMed 8952375Varni 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.
PubMed 10024117Tschannen-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.
PubMed 24641907Moses T. Stigma and self-concept among adolescents receiving mental health treatment. Am J Orthopsychiatry. 2009 Apr;79(2):261-74. doi: 10.1037/a0015696.
PubMed 19485644Hamdani 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.
PubMed 32838678
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04091633
- Acronym / sponsor ID
- SHINE / SHINE cRCT
- Conditions
- Behavioral Symptoms, Behavioral Problem, Emotional Problem, Emotional Stress, ADHD, Emotional Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 971 participants (actual)
- Lead sponsor
- Human Development Research Foundation, PakistanUniversity, hospital or other
- Collaborators
- University of Liverpool, University of Washington, Pakistan Ministry of Health, World Health Organization, National Institute of Mental Health (NIMH), Liverpool School of Tropical Medicine, Harvard University
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single blind, two arm, cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| School Mental Health Program-Conventional (cSMHP) | Active comparator | Behavioral: WHO School Mental Health ProgramThe 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. |
| Enhanced-School Mental Health Program (eSMHP) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
- Screen positive on teacher-rated SDQ (total difficulties score > 12) and parent-rated SDQ (total difficulties score ≥ 14).
Key exclusion criteria (4 listed)
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WHO School Mental Health ProgramWorld 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. | Behavioural | School Mental Health Program-Conventional (cSMHP) |
| 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. | Behavioural | Enhanced-School Mental Health Program (eSMHP) |
Primary outcome
Strengths and Difficulties Questionnaire (SDQ)
Time frame: Baseline and at 9 months after commencing intervention delivery
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
12 secondary outcomes
Externalizing and internalizing problems on parent-rated SDQ
Time frame: Baseline and at 9 months after commencing intervention delivery
Child's psycho-social well being and functioning (PSYCHLOPS)-Kids
Time frame: Baseline, at 3 and 9 months after commencing intervention delivery
Pediatric Quality of Life (Peds-QL)
Time frame: Baseline and at 9 months after commencing intervention delivery
WHO-Disability Assessment Scale Child Version (WHO-DAS Child 12)
Time frame: Baseline and at 9 months after commencing intervention delivery
Academic performance and absenteeism
Time frame: Baseline and at 9 months after commencing intervention delivery
Teachers' Sense of Efficacy Scale (TSES)
Time frame: Baseline, at 3 and 9 months after commencing intervention delivery
Self-Reporting Questionnaire (SRQ)
Time frame: Baseline, at 3 and 9 months after commencing intervention delivery
Parent Teacher Involvement Questionnaire (PTIQ)
Time frame: Baseline and at 9 months after commencing intervention delivery
Psycho-Social Environment (PSE) Profile
Time frame: Baseline and at 9 months after commencing intervention delivery
Determinants of Implementation Behavior Questionnaire (DIBQ)
Time frame: At 3 months after commencing intervention delivery
Slef-rated Paediatric Self-Stigmatization Scale (PaedS)
Time frame: Baseline and at 9 months after commencing intervention delivery
Client Services Receipt Inventory
Time frame: Baseline and at 9 months after commencing intervention delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Background: PubMed 9255702Goodman 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.
- Background: PubMed 32677230Godfrey 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.
- Background: PubMed 8952375Janca 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.
- Background: PubMed 10024117Varni 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.
- BackgroundTschannen-Moran, M. and A.W. Hoy, Teacher efficacy: Capturing an elusive construct. Teaching and teacher education, 2001. 17(7): p. 783-805.
- BackgroundBeusenberg, M., J.H. Orley, and W.H. Organization, A User's guide to the self reporting questionnaire (SRQ. 1994, Geneva: World Health Organization
- BackgroundOrganization, W.H., Creating an environment for emotional and social well-being: an important responsibility of a health promoting and child-friendly school. 2003
- Background: PubMed 24641907Huijg 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.
- Background: PubMed 19485644Moses T. Stigma and self-concept among adolescents receiving mental health treatment. Am J Orthopsychiatry. 2009 Apr;79(2):261-74. doi: 10.1037/a0015696.
- Derived from this study: PubMed 32838678Hamdani 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.
- Individual participant dataSharing planned: Yes. In compliance with the data sharing agreement, the unidentifiable data set will be periodically submitted to the online NIMH data repository- National Database for Clinical Trials Related to Mental Illness (NDCT).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atif Rahman, PhD principal investigator
University of Liverpool
Lawrence Wissow, MD principal investigator
University of Washington, Seattle, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WHO School Mental Health Program and Enhanced School Mental Health Program (eSMHP) in people with Behavioral Symptoms and Behavioral Problem, run by Human Development Research Foundation, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strengths and Difficulties Questionnaire (SDQ) (time frame: Baseline and at 9 months after commencing intervention delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04091633, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.