AnxietyNCT06155838
Reducing Depression and Anxiety Among Teens
A study testing "Early Adolescent Skills for Emotions (EASE) in people with Anxiety and Depression, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The objective of this clinical trial is to assess the efficacy of the Early Adolescent Skills for Emotions (EASE) program, a school-based, non-specialist psychosocial intervention developed by the WHO for LMICs, in alleviating Anxiety and Depression among teens aged 13-19. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- "Early Adolescent Skills for Emotions (EASE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Nov 2023to 31 Mar 2024
- 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Teens aged 13-19 years
- Living with parents/primary caregivers
- Enrolled in public middle and high schools of Multan, Southern Punjab, Pakistan
- Teens Assent - agreed and signed by teen
- Informed consent from parents- agreed and signed by parents
Who cannot join
- Teens part of a dysfunctional family
- Psychiatric issues
- Physical and sensory disorder diagnosis.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Office of the Chief Executive Officer, District Education Authority, Multan
Multan Khurd, Punjab Province
About this study
Official title: Reducing Depression and Anxiety Among Teens in Multan, Pakistan: a Cluster Randomized Controlled Trial
The objective of this clinical trial is to assess the efficacy of the Early Adolescent Skills for Emotions (EASE) program, a school-based, non-specialist psychosocial intervention developed by the WHO for LMICs, in alleviating Anxiety and Depression among teens aged 13-19. The primary inquiries it seeks to address include:
Does the EASE intervention effectively reduce anxiety and depression scores 12 weeks after implementation?
- Can the EASE intervention enhance quality of life, improve problem-solving skills, and increase perceived emotional support?
- Is the EASE intervention beneficial for enhancing the psychological well-being of parents and fostering positive parent-teen relationships?
Read the detailed description
Background:
Anxiety and depression significantly impact global adolescent mental health, with 1 in 4 adolescents requiring immediate attention. Many mental health disorders emerge in late childhood and early adolescence, worsening the burden on youth and later in life. In severe cases, suicide can occur at an alarming rate of one person every 40 seconds. In Pakistan, with a large population of 220 million, 50% aged between 12-25, the rates of anxiety and depression among adolescents are concerning. A recent study of 400 high school adolescents (15-18 years) in Pakistan revealed a prevalence of around 53% for anxiety and depression. Early preventive interventions like cognitive behaviour therapy and interpersonal therapy can empower adolescents to manage these issues, but accessing mental health services conveniently remains a challenge. Engaging mainstream academic institutions for early intervention in schools is crucial to combat anxiety, depression, and suicidal thoughts among adolescents in Pakistan.
Introduction:
Anxiety and depression pose significant psychological distress and mental health challenges for adolescents worldwide, highlighting the need for evidence-based psychological interventions tailored to teens. This study aims to assess the effectiveness of a school-based psychosocial intervention, the Early Adolescent Skills for Emotions (EASE) program developed by the WHO, in reducing psychosocial distress among adolescents aged 13-19.
Method and Analysis:
A two-parallel-arm, single-blinded, cluster randomized controlled trial will be conducted in Multan, Pakistan's school settings. Eight eligible public school clusters will be randomly allocated in a 1:1 ratio to the control arm (n=4) and intervention arm (n=4). The trial will recruit 450 adolescents (56 students from each school) experiencing psychosocial distress between April and May 2023. In the intervention arm, teens will receive the EASE program over 7 weeks, featuring psychoeducation, stress management, behavioural activation, problem-solving, and relapse prevention. Teachers will be trained in active listening, quality time spent, and the use of praise to assist their students. A qualitative study will explore facilitating and challenging factors related to intervention in low-resource school settings.
Ethical Approval:
Ethical approval has been obtained from the Ethics Committee of the School of Nursing at Shandong University, Jinan, China.
- Conditions
- Anxiety, Depression
- Being tested
- "Early Adolescent Skills for Emotions (EASE)
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Early Adolescent Skills for Emotions (EASE)Other
Weekly Schedule for Teen's and their parents Sessions:
Over the course of 7 sessions, with one session per week lasting 90 minutes, the following core components will be covered:
Week 1: Exploring My Feelings
Week 2: Learning to Calm
Week 3 \& 4: Learning CBT- Restructuring My Thinking, Changing Feelings and My Actions \& Managing My Emotions and Issues
Week 5 \& 6: Fostering Independent Problem-Solving Skills and Seeking Help
Week 7: Relapse Prevention
2.0 For parents/ guardians
Week 3 Psychoeducation (to develop skills to be able to identify, listen, better respond and provide comfort to teens when they are overwhelmed by anxiety and depression).
Week 4 Positive parenting strategies
Week 5 Parents/ guardians Self-care
| Study group | Role | What they receive |
|---|---|---|
| EASE Intervention | Experimental | The intervention consists of four fundamental themes that have empirical support, structured across seven group sessions for adolescents and three group sessions for their parents or guardians. The sessions for teenagers will be conducted in person, spanning seven weeks with one session per week, each lasting 90 minutes. Similarly, three sessions are scheduled for parents.
In accordance with WHO guidelines (2016), the intervention will be administered by non-specialist co-facilitators(class teachers) who possess at least 16 years of education (undergraduate degree). These co-facilitators will undergo a ten-day training program, demonstrating mock sessions as part of this training. During the intervention delivery, they will also benefit from weekly supervision provided by a specialist, who will be a graduate psychologist or trained nurse in mental health. Receives: Other: "Early Adolescent Skills for Emotions (EASE) |
| control/ wait list | No intervention | Throughout the study, participants in the control group will continue to receive standard treatment. Nevertheless, following the conclusion of the trial, all control group participants will undergo the EASE intervention over a seven-week period, which will also involve three sessions for their parents and guardians. This approach ensures that the control group is not placed at a disadvantage, in alignment with ethical principles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aga Khan University Anxiety and Depression Scale (AKUADS-25)
AKUADS will be used to assess anxiety and depression affecting the target population. Items score ranges from 0-3 (0= never, 1=sometime, 2=mostly, 3=always) for each question item hence the total score of the tool is 0-75. The higher the score the more anxiety and depression will be severe with the cut score of 19.
Measured: at 12 weeks' post-intervention
Secondary outcomes (8)
The Kessler Psychological Distress Scale -10 (K-10)
K-10 will assess psychological distress among teens and parents. It will be measured on a scale from five to one (5=all of the time; 4= Most of the time; 3 some of the time; 2= A little of the time; 1= none of the time). The scores range from 6 to 30, by summing the individual items, total scores are calculated. The higher scores indicate high psychological distress.
Measured: at 12 weeks' post-intervention
The Perceived Emotional/Personal Support Scale ( PEPSS)
The Perceived Emotional/Personal Support Scale ( PEPSS) measures the perceived emotional support. On a four-point scale - hardly at all 4 to very much 1. The higher scores show a lack of perceived support.
Measured: at 12 weeks' post- intervention
The Social Problem-Solving Inventory-Revised Short Form- 25
it measures problem-solving skills in a situation. The total score of this scale varies between 0 and 20 points. The highest scores correspond to better social problem-solving abilities.
Measured: at 12 weeks' post- intervention
Parent-rated Pediatric Quality of Life (PedsQL).
This tool will be utilized to assess the child's quality of life (health-related). This tool measures a child's quality of health on a points Likert scale ranging from 'no problem= 1' to 'almost always a problem= 4'. "Items are then reverse-scored and linearly transformed to a 0-100 so that higher scores indicate better quality of life.
Measured: at 12 weeks' post- intervention
Parenting practices
The assessment of parenting behaviors and practices will utilize the Alabama Parenting Questionnaire-42 (APQ-42) (Maguin, Nochajski, De Wit, \& Safyer, 2016)., this tool includes five constructs : involvement (10 items), supervision and monitoring (10 items), positive parenting (6 items), consistent discipline (6 items), and corporal punishment (3 items), with the additional 7 items addressing alternative disciplinary practices. Each item, rated on a 5-point scale from 1 (never) to 5 (always), contributes to the construct's score, calculated by summing the relevant items.
Measured: at 12 weeks' post- intervention
The Psychological Sense of School Membership
The assessment of perceived belonging and psychological engagement in school will utilize the Psychological Sense of School Membership (PSSM) scale (Goodenow, 1993). This comprehensive scale delves into the sense of belonging in school environments, focusing on caring relationships, acceptance, and rejection. Comprising 18 items rated on a likert scale from 1 (not at all true) to 5 (completely true), scores are calculated by summing responses and then averaging, resulting in a score range of 1 to 5. Higher scores signify a stronger sense of perceived belonging and engagement within the school community.
Measured: at 12 weeks' post- intervention
Strengths and Difficulty Questionnaire
The Strengths and Difficulties Questionnaire (SDQ), a widely utilized screening tool for assessing psychological adjustment in children and adolescents (Goodman et al., 1998), categorizes positive attributes (strengths) and problematic behaviors (difficulties) across five domains, each comprising 5 items: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior (strengths). Respondents use a Likert scale ("not true= 0," "somewhat true=1," or "certainly true=2") to indicate their response, representing a three-point categorical scale. Scores within each domain are summed, with higher scores in emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems indicating greater difficulties, while higher scores in the prosocial behavior domain signify strengths.
Measured: at 12 weeks' post- intervention
Moderating Factors
We will also explore potential moderating factors that may influence the intervention's effectiveness on the primary outcomes. These factors include gender, age groups, socioeconomic status, parental education, and parents' psychological well-being. Statistical analyses will assess whether these variables moderate the relationship between the intervention and changes in anxiety and depression.
Measured: T1, T2, T3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start27 Nov 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong University
- Responsible party
- Principal investigator, Lubna Ghazal, Aga Khan University
- Investigators
- Lubna Ghazal, Principal investigator, Aga Khan UniversityCoa Fenglin, Study chair, Shandong University - ChinaCui Naixue, Study director, Shandong University - China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155838
- Sponsor's protocol ID
- AgaKhanUGhazalet.al(2023)
- Status last verified
- Jan 2025
- First submitted
- 17 Apr 2023
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As mentioned below.
Publications
Ghazal L, Cui N, Cao F. To evaluate the EASE intervention for reducing anxiety and depression among adolescents in Pakistan: a protocol for a mixed methods study, including a cluster-randomised controlled trial. BMJ Open. 2025 Mar 22;15(3):e086393. doi: 10.1136/bmjopen-2024-086393.
PubMed 40122537
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Depression and Anxiety Among Teens in Multan, Pakistan: a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06155838
- Acronym / sponsor ID
- AgaKhanUGhazalet.al(2023)
- Conditions
- Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Shandong University
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 5 Dec 2023 (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.
The objective of this clinical trial is to assess the efficacy of the Early Adolescent Skills for Emotions (EASE) program, a school-based, non-specialist psychosocial intervention developed by the WHO for LMICs, in alleviating Anxiety and Depression among teens aged 13-19. The primary inquiries it seeks to address include:
Does the EASE intervention effectively reduce anxiety and depression scores 12 weeks after implementation?
- Can the EASE intervention enhance quality of life, improve problem-solving skills, and increase perceived emotional support?
- Is the EASE intervention beneficial for enhancing the psychological well-being of parents and fostering positive parent-teen relationships?
Detailed description
Background:
Anxiety and depression significantly impact global adolescent mental health, with 1 in 4 adolescents requiring immediate attention. Many mental health disorders emerge in late childhood and early adolescence, worsening the burden on youth and later in life. In severe cases, suicide can occur at an alarming rate of one person every 40 seconds. In Pakistan, with a large population of 220 million, 50% aged between 12-25, the rates of anxiety and depression among adolescents are concerning. A recent study of 400 high school adolescents (15-18 years) in Pakistan revealed a prevalence of around 53% for anxiety and depression. Early preventive interventions like cognitive behaviour therapy and interpersonal therapy can empower adolescents to manage these issues, but accessing mental health services conveniently remains a challenge. Engaging mainstream academic institutions for early intervention in schools is crucial to combat anxiety, depression, and suicidal thoughts among adolescents in Pakistan.
Introduction:
Anxiety and depression pose significant psychological distress and mental health challenges for adolescents worldwide, highlighting the need for evidence-based psychological interventions tailored to teens. This study aims to assess the effectiveness of a school-based psychosocial intervention, the Early Adolescent Skills for Emotions (EASE) program developed by the WHO, in reducing psychosocial distress among adolescents aged 13-19.
Method and Analysis:
A two-parallel-arm, single-blinded, cluster randomized controlled trial will be conducted in Multan, Pakistan's school settings. Eight eligible public school clusters will be randomly allocated in a 1:1 ratio to the control arm (n=4) and intervention arm (n=4). The trial will recruit 450 adolescents (56 students from each school) experiencing psychosocial distress between April and May 2023. In the intervention arm, teens will receive the EASE program over 7 weeks, featuring psychoeducation, stress management, behavioural activation, problem-solving, and relapse prevention. Teachers will be trained in active listening, quality time spent, and the use of praise to assist their students. A qualitative study will explore facilitating and challenging factors related to intervention in low-resource school settings.
Ethical Approval:
Ethical approval has been obtained from the Ethics Committee of the School of Nursing at Shandong University, Jinan, China.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EASE Intervention | Experimental | Other: "Early Adolescent Skills for Emotions (EASE)The intervention consists of four fundamental themes that have empirical support, structured across seven group sessions for adolescents and three group sessions for their parents or guardians. The sessions for teenagers will be conducted in person, spanning seven weeks with one session per week, each lasting 90 minutes. Similarly, three sessions are scheduled for parents. In accordance with WHO guidelines (2016), the intervention will be administered by non-specialist co-facilitators(class teachers) who possess at least 16 years of education (undergraduate degree). These co-facilitators will undergo a ten-day training program, demonstrating mock sessions as part of this training. During the intervention delivery, they will also benefit from weekly supervision provided by a specialist, who will be a graduate psychologist or trained nurse in mental health. |
| control/ wait list | No intervention | –Throughout the study, participants in the control group will continue to receive standard treatment. Nevertheless, following the conclusion of the trial, all control group participants will undergo the EASE intervention over a seven-week period, which will also involve three sessions for their parents and guardians. This approach ensures that the control group is not placed at a disadvantage, in alignment with ethical principles. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Teens aged 13-19 years
- Living with parents/primary caregivers
- Enrolled in public middle and high schools of Multan, Southern Punjab, Pakistan
- Teens Assent - agreed and signed by teen
- Informed consent from parents- agreed and signed by parents
Key exclusion criteria (3 listed)
- Teens part of a dysfunctional family
- Psychiatric issues
- Physical and sensory disorder diagnosis.
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 |
|---|---|---|
| "Early Adolescent Skills for Emotions (EASE)Weekly Schedule for Teen's and their parents Sessions: Over the course of 7 sessions, with one session per week lasting 90 minutes, the following core components will be covered: Week 1: Exploring My Feelings Week 2: Learning to Calm Week 3 \& 4: Learning CBT- Restructuring My Thinking, Changing Feelings and My Actions \& Managing My Emotions and Issues Week 5 \& 6: Fostering Independent Problem-Solving Skills and Seeking Help Week 7: Relapse Prevention 2.0 For parents/ guardians Week 3 Psychoeducation (to develop skills to be able to identify, listen, better respond and provide comfort to teens when they are overwhelmed by anxiety and depression). Week 4 Positive parenting strategies Week 5 Parents/ guardians Self-care | Other | EASE Intervention |
Primary outcome
Aga Khan University Anxiety and Depression Scale (AKUADS-25)
Time frame: at 12 weeks' post-intervention
AKUADS will be used to assess anxiety and depression affecting the target population. Items score ranges from 0-3 (0= never, 1=sometime, 2=mostly, 3=always) for each question item hence the total score of the tool is 0-75. The higher the score the more anxiety and depression will be severe with the cut score of 19.
8 secondary outcomes
The Kessler Psychological Distress Scale -10 (K-10)
Time frame: at 12 weeks' post-intervention
The Perceived Emotional/Personal Support Scale ( PEPSS)
Time frame: at 12 weeks' post- intervention
The Social Problem-Solving Inventory-Revised Short Form- 25
Time frame: at 12 weeks' post- intervention
Parent-rated Pediatric Quality of Life (PedsQL).
Time frame: at 12 weeks' post- intervention
Parenting practices
Time frame: at 12 weeks' post- intervention
The Psychological Sense of School Membership
Time frame: at 12 weeks' post- intervention
Strengths and Difficulty Questionnaire
Time frame: at 12 weeks' post- intervention
Moderating Factors
Time frame: T1, T2, T3
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 Feb 2025.
- Derived from this study: PubMed 40122537Ghazal L, Cui N, Cao F. To evaluate the EASE intervention for reducing anxiety and depression among adolescents in Pakistan: a protocol for a mixed methods study, including a cluster-randomised controlled trial. BMJ Open. 2025 Mar 22;15(3):e086393. doi: 10.1136/bmjopen-2024-086393.
- Individual participant dataSharing planned: Yes. As mentioned below.
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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.
Lubna Ghazal principal investigator
Aga Khan University
Coa Fenglin study chair
Shandong University - China
Cui Naixue study director
Shandong University - China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Early Adolescent Skills for Emotions (EASE) in people with Anxiety and Depression, run by Aga Khan University 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 5 inclusion and 3 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 Feb 2025. 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?
Aga Khan University Anxiety and Depression Scale (AKUADS-25) (time frame: at 12 weeks' post-intervention). 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 NCT06155838, which also lists 1 linked publication.
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 Feb 2025.