Depression, Anxiety, Distress, Emotional, Functioning, Psychosocial, Psychosocial Problem
Conditions
Brief summary
This study aims to explore effective ways to reduce depressive symptoms in adolescents through two school-based interventions. This study examines whether the Enhanced School Mental Health Program (eSMHP) Plus, delivered by teachers and non-specialists, can serve as a first-line intervention to reduce psychosocial distress-an intermediate outcome that must be addressed to lower the risk of depression (primary outcome) in adolescents. For those who do not respond to eSMHP Plus, the study investigates if a Cognitive Behavioural Therapy (CBT) based guided self-help app could be an effective step-up or second-level intervention. Researchers will assess the feasibility and acceptability of these approaches among 200 adolescents (aged 13-15) from 8 public schools in Rawalpindi, Pakistan. Findings will guide future large-scale studies and strategies for personalised mental health care for adolescents in low-resource settings.
Detailed description
Background: Internalizing symptoms among adolescents can have long-term devastating impacts on their lives unless they are identified and treated early and effectively. Both universal and indicated school-based interventions are recommended to address internalizing symptoms among adolescents. However, determining the optimal timing and dosage of these interventions remains a crucial question for effective adolescent mental healthcare. The investigators will conduct a pilot Sequential Multiple Assignment Randomized Controlled Trial (SMART) to explore the feasibility and acceptability of two evidence-informed intervention strategies (universal and indicated interventions) within the stepped care model, compare their timing and dosage, and determine in which sequence these interventions should be delivered to whom. This study aims to answer the question, "What works, for whom, under what conditions, and why, for internalizing symptoms in adolescents with a focus on depressive symptoms?" Methods: A 20-week single-blind pilot cluster SMART study will be conducted in 8 public schools in Rawalpindi, Pakistan, to assess the feasibility and acceptability of 2 intervention strategies (i.e., 1. teachers plus non-specialist delivered universal intervention called Enhanced School Mental Health Program \[eSMHP\] Plus and 2. Guided self-help application of Cognitive Behavioural Therapy-based indicated intervention to reduce depression (internalising symptoms) in adolescents. The study participants will be approximately 200 adolescents, aged 13-15 of both sexes, with psychosocial distress. Data on the feasibility and acceptability of the study design, views about augmented intervention options and procedures, and treatment response rates will be collected. Results from the pilot study will yield additional research questions and will improve our ability to successfully conduct the definitive SMART to inform personalised interventions for internalising symptoms in adolescents. Discussion: The findings of the study will be used to inform the design of a subsequent fully powered, definitive SMART study in Pakistan.
Interventions
The first-stage intervention is eSMHP Plus in the intervention arm and eSMHP in the control arm. In the intervention arm, adolescents receive eSMHP Plus from teachers and non-specialists, while in the control arm, they receive eSMHP from teachers. eSMHP, based on developmental, behavioral, social, and cognitive theories, enhances teachers' mental health literacy, training them in early identification, basic counseling, life skills, positive discipline, parental engagement, referrals, and teacher well-being. The second-stage intervention is a CBT-based self-help app. At six weeks, adolescents scoring ≥28 on PSC in both arms (indicating psychosocial distress) are re-randomized to continue their initial treatment (eSMHP Plus or eSMHP) or receive a step-up, CBT-based guided self-help app for two months.
Sponsors
Global Institute of Human Development
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Participants will not be blinded to treatment allocation. However, all outcome measures will be administered by researchers' blind to allocation status. It is not possible to blind adolescents, caregivers, intervention facilitators, intervention supervisors, data managers, or the trial manager to the treatment allocation because of the nature of the intervention. The assessors, trial statistician, and investigator(s) will be blind to treatment allocation status. To ensure masking during the trial, the intervention and assessment teams will be based at separate office locations and will not have any interaction. The assessment team members will also be non-residents of the study place. Furthermore, participants will be each individually instructed not to disclose their treatment allocation status to the assessors during any follow-up assessments. The fidelity of masking will be measured by having assessors guess the condition of each participant at the end of each assessment.
Intervention model description
In this pilot sequential multiple assignment cluster randomized controlled trial, randomization will occur in two stages. First, school clusters (N=8), stratified by sex, will be randomized to intervention or control arms in a 1:1 allocation ratio. Schools in the intervention arm will receive the Enhanced School Mental Health Program (eSMHP) Plus by teachers and non-specialists in classroom settings. It aims at improving providers' mental health literacy, enabling early identification and management of socioemotional issues in adolescents, and enhancing teachers' well-being. Adolescents in the control arm will receive Enhanced Treatment as Usual (ETAU), which is eSMHP delivered by teachers only. At 6 weeks from baseline, a second randomization will occur at the individual level based on gender and PSC scores. In both arms, adolescents scoring ≥28 on PSC will be re-randomised to continue initial treatment (eSMHP Plus or eSMHP) or a step-up CBT-based guided self-help app.
Eligibility
Sex/Gender
ALL
Age
13 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
1\. Adolescents aged 13-15 years, studying in grades 7 and 8 of participating schools, provide assent and parental consent for participation in the study and screen positive for psychosocial distress on youth reported PSC (total score ≥ 28).
Exclusion criteria
1. Adolescents who require immediate in-patient (medical and/or psychiatric) care 2. Adolescents with acute protection risks as assessed by a researcher applying the definitions in the WHO mhGAP intervention guide.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) for adolescents | Enrollment, and 6 weeks and 3-months from baseline | Patient Health Questionnaire (PHQ-9) for adolescents is a 9-item instrument (on a 4-point Likert scale; range 0-27) to measure depressive symptoms in the past 2 weeks (Richardson et al., 2010) and that is previously adapted, validated and shown high reliability in Pakistan (Cronbach α=0.83). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Symptoms Checklist (PSC) | Enrollment, and 6 weeks and 3-months from baseline | PSC will also serve as an intermediate tailoring variable. It is well-established 35-item scale. It consists of three subscales, internalizing, externalizing and attention problems. The Urdu version has been previously adapted and used in Pakistan, showing satisfactory reliability and validity. |
| Revised Children's Anxiety and Depression Scale (RCADS) | From enrollment to the end of treatment at 3-months | It is a 25-item instrument (on a 4-point Likert scale; range 0-100) to measure levels of anxiety and low mood. It has two subscales (anxiety \& depression). It has been adapted and used successfully in Pakistan. |
| Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom Measure | From enrollment to the end of treatment at 3-months | It is a self-rated measure that assesses mental health domains that are important across psychiatric diagnoses. It is intended to help identify additional areas of inquiry that may have a significant impact on the child's treatment and prognosis. Each item on the measure is rated on a 5-point scale (0=none or not at all; 1=slight or rare, less than a day or two; 2=mild or several days; 3=moderate or more than half the days; and 4=severe or nearly every day). A rating of mild (i.e., 2) or greater on any item within a domain (except for suicidal ideation and psychosis) will serve as a guide for additional inquiry and follow-up to determine if a more detailed assessment for that domain is necessary. |
| Checklist of Somatic Symptoms of Distress | From enrollment to the end of treatment at 3-months | It is a 10-item tool (on a 3-point Likert scale); 0-20 to measure somatic symptoms of distress. It has been previously adapted and used in Pakistan. |
| Experience of bullying | From enrollment to the end of treatment at 3-months | Experience of bullying in the past 30 days will be measured through the contextualised version of the Bullying Victimization Questionnaire. The total score can range from 0 to 12, with higher scores indicating higher levels of victimization by peers. |
| School climate | From enrollment to the end of treatment at 3-months | The change in school climate (students' relationship with teachers, belongingness with the schools and peers, students' commitment to the school tasks, and participation in school activities) will be measured using the adapted version of the Beyound Blue School Climate Questionnaire. The tool will be administered to both children and their caregivers. The questionnaire consists of 28 items. Each item is rated on a 3-point Likert scale (yes=1, No = 0, I can't say = no score). The total score of BBSCQ can range from 0 to 28, where higher scores indicate a more favourable view of the school climate. |
| Annual academic performance and classroom attendance questionnaire | From enrollment to the end of treatment at 3-months | A study-specific questionnaire will be developed to obtain records of attendance and academic grades from the school records at baseline and 3 months post-intervention delivery. |
| Wellbeing | From enrollment to the end of treatment at 3-months | Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWS): It is a 7-item scale and assesses the mental wellbeing by evaluating the functioning of thoughts and feelings in the past two weeks. Items are rated on Likert scale that ranges from "none of the time" to "all of the time". The total score is calculated by summing the responses on all the items. |
| Teachers' wellness | From enrollment to the end of treatment at 3-months | The Self Reporting Questionnaire (SRQ) is a 20-item self-report measure to detect non-specific psychological distress, developed by the WHO. 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 |
| Teachers' sense of self-efficacy | From enrollment to the end of treatment at 3-months | The 12 items Teachers Sense of efficacy scale will be used to assess teacher's belief about his or her capabilities to enhance students' learning and to be able to support students who are difficult or unmotivated. The scale measures teacher's efficacy on three subscales namely, instructional strategies, student engagement, and classroom management. The items are rated on 5 points Likert scale ranging from (1) 'None at all' to (5) 'A great deal'. |
| Psychosocial Profile of the School | From enrollment to the end of treatment at 3-months | 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. To obtain an overall mean or average, the scores of all the answered questions are added and divided by the total number of questions answered. Higher scores indicate a better psychosocial environment at the school. |
| Caregivers' Wellbeing | From enrollment to the end of treatment at 3-months | The Self Reporting Questionnaire (SRQ) is a 20-item self-report measure to detect non-specific psychological distress, developed by the WHO. 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 |
| Alabama Parenting Questionnaire (APQ) | From enrollment to the end of treatment at 3-months | The positive involvement subscale of the Alamaba Parenting Questionnaire (APQ) will be used to measure parenting practices. The subscale measures whether parents talk more friendly with children; help children in planning and conducting special activities; know what they are doing in their free time; play games with them; help them with their homework; get interested in their day-to-day plans and activities; and know about their friends. Items are rated on a five-point Likert scale (1 = never to 5 = almost always). The total score is calculated by summing all the items. The minimum score is 10, and the maximum score is 50. Higher scores indicate more positive outcomes. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORSyed Usman Hamdani, PhD MBBS
Global Institute of Human Development
Outcome results
None listed