Testing the Feasibility of a Sports-based Mental Health Promotion Intervention for Adolescents in Nepal

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2024-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Each year, one in five adolescents experiences a mental disorder like depression or anxiety, and the rate is rising. Depression is a common mental disorder, one of the leading global causes of Disability Adjusted Life Years among adolescents, and can lead to learning, behavioural and social impairment, as well as comorbid cardiovascular disease and mental illness in adulthood. An intervention is needed that can protect adolescents from mental disorders, is accessible to all adolescents, and is cheap and easy to sustain. One such intervention is mental health promotion, which focuses on improving positive behaviors and characteristics that protect mental health. There is already a strong evidence base for treatment and indicated prevention approaches, but a lack of research on mental health promotion interventions. In low resourced settings like Nepal, interventions need to be short of duration, and be carried out by lay people in the communities to make them sustainable and feasible to implement on a broader scale. The aim of this study is to develop and test the feasibility and acceptability of an intervention that uses sports groups to engage and improve the mental health of adolescents in Nepal.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

School-based IPT-G for Adolescents With Depression in Nepal: a Pilot Realist C-RCT

NCT06017700

Depression

UNKNOWN NA

Prevention of Depression in At-Risk Adolescents

NCT00073671

Depression

COMPLETED NA

Implementation Research on the Intervention Mode of " Comorbidity-Co-causes-Joint-prevention" Comprehensive Demonstration District of Depression and Obesity Among Children and Adolescents in Beijing

NCT06489990

Depression Obesity High Risk of Depression +1 more

NOT_YET_RECRUITING NA

Brief Transdiagnostic Group CBT for Adolescents With Internalizing Problems: A Randomized Waitlist Controlled Trial

NCT04716777

Anxiety Disorders Depressive Disorder Anxiety +1 more

UNKNOWN NA

Reducing Health Risk Behavior and Improving Health in Adolescents With Depression

NCT00461539

Depression Adolescent Health

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Depression and anxiety are the leading contributors to the global burden of disease among young people, accounting for over a third (34.8%) of years lived with disability, and contributing significantly to excess mortality through suicide. Adolescence is the peak age of onset for most mental health conditions, with approximately 50% of lifetime mental health conditions having their onset by mid-adolescence. Adolescent depression in turn predicts several adverse life trajectories, such as failure to complete secondary school, unemployment and unplanned pregnancy or parenthood. Early intervention programmes for adolescents can promote mental health, prevent mental disorders, and prevent risky behaviours and other unhealthy lifestyle choices. These programmes have the potential to make positive contributions to adolescents' health, and to their health in later life. One such intervention is mental health promotion, which focuses on improving positive behaviors and characteristics that protect mental health. Mental health promotion is a strategy to improve the positive behaviors and characteristics that protect mental health

A pilot trial will be conducted to assess the feasibility, acceptability and utility of the intervention and trial design; safety and delivery of the intervention in the community settings; and to identify issues around training, supervision and outcomes measures. A household survey will be conducted at baseline and end line data collection points. After a baseline data collection, the implemention of the intervention will be conducted for around 10 months' period, and then collect the follow-up (end line) data with adolescents.

A parallel-group, two-arm, superiority, cluster-randomised controlled trial with 1:1 allocation to intervention and control arms will be done. In total there will be four clusters (2 control and 2 intervention clusters). The unit of randomization will be a geographic village cluster of \~1000 people (approx 160 adolescents in each cluster). Clusters will be separated geographically which will mitigate risk of contamination in the control arm. A researcher will visit each household in the clusters and ask if there are any adolescents living in the household. Where appropriate consent is obtained, the researcher will then interview eligible adolescents using a smartphone or tablet pre-programmed with the survey. The main trial analysis will be a cross-sectional comparison of data from the endline survey, adjusted for baseline differences. Intervention activities will be open to all adolescents aged 12-19 living in the community to participate. The acceptability of the intervention, randomisation, tools, uptake, utility of the intervention, facilitators' fidelity to the manual, mental health outcome trends, and cost of design and delivery of the intervention will be assessed. The intervention process data will be also collected. This will include FGDs and interviews with adolescents and their parents, facilitators and trainers to explore feasibility and acceptability of the intervention and study procedures.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mental Health Wellness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A parallel-group, two-arm, superiority, cluster-randomised controlled trial with 1:1 allocation to intervention and control arms will be used in the study. Two cross-sectional household surveys of adolescents, one at baseline and one at end line will be conducted.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention arm - sport based mental health promotion program

The experimental arm will receive an intervention for around 10 months' period after baseline data collection.

Group Type EXPERIMENTAL

sports based mental health promotion program

Intervention Type OTHER

sports related programs

Control group - treatment as usual

This group receive the intervention available in the existing health care and education system in the study area.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

sports based mental health promotion program

sports related programs

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

sports related program

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Any adolescent boy or girl aged 12-19 years
2. Adolescents in or out of school
3. Married or unmarried
4. Who lives in the study clusters
5. Able to speak and listen

Exclusion Criteria

1. Participants who are unable to provide a written consent
2. People having severe mental illness or severe physical disability
3. Participants who are planning to move from the study sites during the study period

Minimum Eligible Age

12 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes