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临床试验/NCT06942637
NCT06942637已完成不适用

Effectiveness of Integrated Network for Student Psychosocial Intervention, Resilience, and Education (INSPIRE) on Mental Health Outcomes Among Indonesian Adolescents in Bandung: A Randomised Controlled Trial and Process Evaluation

National University of Singapore2 个研究点 分布在 2 个国家目标入组 700 人开始时间: 2025年4月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
700
试验地点
2
主要终点
Adolescents' mental health knowledge

研究概览

简要总结

The INSPIRE (Integrated Network for Student Psychosocial Intervention, Resilience, and Education) intervention is an 8-week, school-based mental health program designed to enhance adolescents' mental health literacy and resilience while addressing symptoms of depression and anxiety. Implementation is conducted by school counselors who undergo an intensive two-day training program. The intervention is supported by comprehensive curriculum materials including detailed lesson plans, activities, discussion prompts, and instructional slides featuring key concepts, visuals, and explanatory content. Supplementary materials are developed for both participating adolescents and their parents.

The study aims to:

  1. Evaluate the usability and feasibility of the INSPIRE intervention within the school environment.
  2. Assess the intervention's effectiveness in improving:
  • Primary outcome: Mental health knowledge among adolescents
  • Secondary outcomes: Attitudes toward mental health, help-seeking behaviors, mental health literacy, resilience, and symptoms of depression and anxiety among adolescents
  • Secondary outcomes: mental health knowledge, attitudes, help-seeking behaviors, and mental health literacy among parents
  1. Explore the experiences of intervention participants (both adolescents and parents) against the control group to develop comprehensive insights into the psychosocial intervention's impact.

The research hypothesis proposes that the INSPIRE intervention group will demonstrate significantly higher scores in mental health knowledge, more positive attitudes toward mental health, increased help-seeking behaviors, enhanced mental health literacy, and greater resilience, while simultaneously showing reduced symptoms of depression and anxiety compared to the control group receiving standard care. These outcomes will be measured immediately following the intervention (post-test 1) and at one-month follow-up (post-test 2).

详细描述

Pilot Study The pilot study was conducted as a two-centre, two-arm cluster randomised controlled trial with a pre-test-post-test design and a 1:1 allocation ratio. Randomisation was performed at the school (cluster) level to minimise contamination. The pilot phase was implemented from 28 April to July 2025.

Randomised Controlled Trial (RCT) The full-scale randomised controlled trial expanded to a multi-centre design involving five centres, maintaining a two-arm cluster randomised structure with school-level allocation. The trial was conducted in two phases. Phase 1 randomised two schools (School 1 and School 2), with one allocated to the control group and the other to the intervention group. Phase 2 randomised three additional schools (Schools 3, 4, and 5) with a 1:2 allocation ratio (one to control, two to intervention) to address recruitment shortfalls.

The RCT commenced in September 2025. Participant recruitment and baseline data collection occurred between 12 September and 21 November 2025. Follow-up for primary and secondary outcomes was completed on 27 March 2026.

Process Evaluation Process evaluation was conducted from 18 December 2025 to 7 April 2026.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
13 Years 至 15 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Participants were initially restricted to students aged 13-15 years. However, the inclusion criteria in the RCT were subsequently broadened to encompass all junior high school students (grades 7-9) to ensure adequate recruitment and representativeness. Eligible students were required to be able to read, understand, and converse in Bahasa Indonesia.
  • •The inclusion criteria for parents are as follows:
  • •The biological father, mother, or an adult who fulfils a parental or guardian role for the participating adolescent
  • •Able to understand and communicate in Bahasa Indonesia.

排除标准

  • •Adolescents who are working, clinically diagnosed with severe mental disorders, such as schizophrenia or psychosis, at high risk for mental health disorders (e.g., teenage pregnancy), or are cognitively impaired will be excluded.
  • •Parents with severe mental disorders or cognitive impairment that may hinder participation will be excluded.

研究组 & 干预措施

Standard school health routine care

No Intervention

INSPIRE Intervention

Experimental

Receive an 8-week school-based program aimed at enhancing adolescent mental health, attitudes towards mental health and help-seeking behaviors, mental health literacy, resilience and addressing depression and anxiety.

干预措施: INSPIRE (Integrated Network for Student Psychosocial Intervention, Resilience, and Education) (Behavioral)

结局指标

主要结局

Adolescents' mental health knowledge

时间窗: At one-month follow-up (post-test 2).

13-item mental health knowledge scale. Total scores range from 0 to 13, with higher scores indicating better mental health knowledge.

Adolescents' mental health knowledge

时间窗: Immediately following the intervention (post-test 1)

13-item mental health knowledge scale. Total scores range from 0 to 13, with higher scores indicating better mental health knowledge.

次要结局

  • Adolescents' attitudes towards mental health(At one-month follow-up (post-test 2).)
  • Adolescents' attitudes towards mental health(immediately following the intervention (post-test 1))
  • Adolescents' attitudes toward help-seeking behaviors(Immediately following the intervention (post-test 1))
  • Adolescents' mental health literacy(Immediately following the intervention (post-test 1))
  • Adolescents' resilience(Immediately following the intervention (post-test 1))
  • Adolescents' depression(Immediately following the intervention (post-test 1))
  • Adolescents' anxiety(Immediately following the intervention (post-test 1))
  • Parents' mental health knowledge(Immediately following the intervention (post-test 1))
  • Parents' attitudes towards mental health(immediately following the intervention (post-test 1))
  • Parents' attitudes toward help-seeking behaviors(Immediately following the intervention (post-test 1))
  • Parents' mental health literacy(Immediately following the intervention (post-test 1))
  • Adolescents' attitudes toward help-seeking behaviors(At one-month follow-up (post-test 2).)
  • Adolescents' mental health literacy(At one-month follow-up (post-test 2).)
  • Adolescents' resilience(At one-month follow-up (post-test 2).)
  • Adolescents' depression(At one-month follow-up (post-test 2).)
  • Adolescents' anxiety(At one-month follow-up (post-test 2).)
  • Parents' mental health knowledge(At one-month follow-up (post-test 2).)
  • Parents' attitudes towards mental health(At one-month follow-up (post-test 2).)
  • Parents' attitudes toward help-seeking behaviors(At one-month follow-up (post-test 2).)
  • Parents' mental health literacy(At one-month follow-up (post-test 2).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shefaly Shorey

Associate Professor

National University of Singapore

研究点 (2)

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