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临床试验/CTRI/2024/11/077115
CTRI/2024/11/077115尚未招募不适用

Social Marketing Intervention for adverse Child-family relationships, Alcohol-usage and Sexual-health Issues attributable to Social-Media-Usage among Adolescents: A Multi-City Cluster Randomized Controlled Trial in North-India.

Dr. Tanvi Kiran1 个研究点 分布在 1 个国家目标入组 1,260 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,260
试验地点
1
主要终点
1) Average amount of time spent on social media

研究概览

简要总结

With increasing digital use, especially in North India, there is a paucity of literature on pathways and connections between social media use and attributable family relationships, alcohol use, and sexual health issues. A novel social marketing intervention is planned to effectively address the aforementioned adolescent health issues early on and build a mutually beneficial interface between parents, school-going adolescents, school authorities, and health professionals. The study aims to explore the impact of social media use on alcohol consumption, sexual health, and adverse child-family relationships among adolescents. Additionally, it proposes the development, implementation, and economic evaluation of Social Marketing Intervention to address these issues and promote adolescent well-being in the digital age.  A cluster randomized controlled trial is planned on school-going adolescents (aged 14-17 years) covering 12 schools across Tricity of Chandigarh, Panchkula (Haryana) and Mohali (Punjab). Formative research shall be conducted to design a novel Social-Marketing intervention to dynamically influence behaviour change among adolescents  wherein parents and teachers shall also play as key stakeholders in facilitating the intended behaviour change. Intervention shall be given on monthly basis for 3 months with monthly follow-up for three months. Generalized-Estimating-Equations modelling shall be undertaken to assess the study outcomes at different periods. Hybrid economic simulation (Decision Tree and Markov model) is proposed to be used for cost-effectiveness analysis. Cost-effective analysis can provide some insight for policy-makers to plan for introducing the intervention on a larger scale in the Indian context.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
14.00 Year(s) 至 17.00 Year(s)(—)
性别
All

入选标准

  • The inclusion criteria include all the following points- 1) School-going adolescents aged 14-17 years, encompassing all genders and enrolled in classes 9th to 12th within government or private schools of the Tricity (Cities of Chandigarh, Panchkula, Mohali).
  • Adolescents who provide their assent along with parental consent to participate in this study.
  • Adolescents who have smartphones/tablets/laptops with their own social media accounts.

排除标准

  • The participant falling under any of the following categories will be excluded- 1) Adolescents below 14 or above 17 years old in classes 9th to 12th.
  • Adolescents who do not provide their assent or if their parents do not provide consent to participate in this study 3) Adolescents who do not have access to smartphones or internet access to use their social media accounts.
  • An adolescent having been diagnosed with mental health problems or other chronic medical diseases.
  • Parents and teachers who refuse to participate in the study.

结局指标

主要结局

1) Average amount of time spent on social media

时间窗: 1) Baseline (outcomes will be measured after 3 months of the start date of the project) | 2) Outcomes will be measured immediately post-intervention | 3) Outcomes will be measured one month post-intervention | 4) Outcomes will be measured two months post-intervention | 5) Outcomes will be measured three months post-intervention

2) Proportion of students witnessing excessive social media usage

时间窗: 1) Baseline (outcomes will be measured after 3 months of the start date of the project) | 2) Outcomes will be measured immediately post-intervention | 3) Outcomes will be measured one month post-intervention | 4) Outcomes will be measured two months post-intervention | 5) Outcomes will be measured three months post-intervention

3) Frequency of alcohol usage

时间窗: 1) Baseline (outcomes will be measured after 3 months of the start date of the project) | 2) Outcomes will be measured immediately post-intervention | 3) Outcomes will be measured one month post-intervention | 4) Outcomes will be measured two months post-intervention | 5) Outcomes will be measured three months post-intervention

4) Binge drinking episodes

时间窗: 1) Baseline (outcomes will be measured after 3 months of the start date of the project) | 2) Outcomes will be measured immediately post-intervention | 3) Outcomes will be measured one month post-intervention | 4) Outcomes will be measured two months post-intervention | 5) Outcomes will be measured three months post-intervention

5) Harmful alcohol use episodes (causing violence/injury under alcohol use)

时间窗: 1) Baseline (outcomes will be measured after 3 months of the start date of the project) | 2) Outcomes will be measured immediately post-intervention | 3) Outcomes will be measured one month post-intervention | 4) Outcomes will be measured two months post-intervention | 5) Outcomes will be measured three months post-intervention

6) Average amount of time spent with parents

时间窗: 1) Baseline (outcomes will be measured after 3 months of the start date of the project) | 2) Outcomes will be measured immediately post-intervention | 3) Outcomes will be measured one month post-intervention | 4) Outcomes will be measured two months post-intervention | 5) Outcomes will be measured three months post-intervention

7) Frequency of Open/ direct/ face-to-face communication with parents

时间窗: 1) Baseline (outcomes will be measured after 3 months of the start date of the project) | 2) Outcomes will be measured immediately post-intervention | 3) Outcomes will be measured one month post-intervention | 4) Outcomes will be measured two months post-intervention | 5) Outcomes will be measured three months post-intervention

8) Proportion of child-parents conflict

时间窗: 1) Baseline (outcomes will be measured after 3 months of the start date of the project) | 2) Outcomes will be measured immediately post-intervention | 3) Outcomes will be measured one month post-intervention | 4) Outcomes will be measured two months post-intervention | 5) Outcomes will be measured three months post-intervention

9) Amount of knowledge regarding sexual health/ physical relation

时间窗: 1) Baseline (outcomes will be measured after 3 months of the start date of the project) | 2) Outcomes will be measured immediately post-intervention | 3) Outcomes will be measured one month post-intervention | 4) Outcomes will be measured two months post-intervention | 5) Outcomes will be measured three months post-intervention

10)Proportion of students having knowledge regarding protective sexual behaviour

时间窗: 1) Baseline (outcomes will be measured after 3 months of the start date of the project) | 2) Outcomes will be measured immediately post-intervention | 3) Outcomes will be measured one month post-intervention | 4) Outcomes will be measured two months post-intervention | 5) Outcomes will be measured three months post-intervention

次要结局

  • 1) The proportion of students using unprotected sexual behaviour(2) Reduction in risky sexual behaviour episodes, if any)

研究者

发起方
Dr. Tanvi Kiran
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Tanvi Kiran

Post Graduate Institute of Medical Education and Research (PGIMER)

研究点 (1)

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