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临床试验/NCT04875507
NCT04875507Unknown不适用

The Use of a Positive Psychology Intervention (PPI) to Promote the Psychological Well-being of Children Living in Poverty: a Feasibility Randomized Controlled Trial

The Hong Kong Polytechnic University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
2
主要终点
Consent rate

研究概览

简要总结

Positive psychology interventions use positive psychology techniques to identify meaning and value in life events to raise positive feelings and emotions. Application of PPIs has steadily increased in clinical and non-clinical samples. However, that meta-analysis did not include any study in a Chinese population, and it remains unclear whether PPIs are applicable in the Hong Kong Chinese context.

详细描述

A randomized controlled trial will be conducted. A convenience sample of 120 patients age 13 to 17 years with no cognitive and/or behavioral problem(s) will be recruited in secondary school around Kwai Chung Estate Participants will be randomized into experimental and control group. The experimental group, who will receive a 1.5-hour workshop covering positive psychology techniques delivered by a qualified research assistant, in groups of less than 5 people, and a booster intervention at 1 week. The control group will received no intervention. Data collection will be conducted at baseline, 1 week, 1month, 3months and 6 months for both groups.

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 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age from 13-17
  • Can read Chinese and speak Cantonese

排除标准

  • with identified cognitive and/or behavioral problem(s)
  • with identified mental problem(s)
  • participating in any mental health service/programme and/or receiving any psychiatric medication.

结局指标

主要结局

Consent rate

时间窗: At baseline

The number of eligible children who consent to participate divided by the number of eligible children

Completion rate at 6-month follow-up

时间窗: At 6-month follow-up

The number of participants who return the questionnaires divided by the number of questionnaires distributed

Adverse events at baseline

时间窗: At baseline

unfavorable and unintended events

Screening rate

时间窗: At baseline

The number of children screened by the RA divided by the number of children available for screening during the recruitment period.

Retention rate at 6-month follow-up

时间窗: At 6-month follow-up

The number of participants who remain in this study divided by the number of randomized participants, calculated by group at each follow-up

Eligibility rate

时间窗: At baseline

The number of eligible children divided by the number of screened children

Randomization rate

时间窗: At baseline

The number of children randomized to the experimental and control groups divided by the number of consenting children

Intervention attendance rate at 1-week follow-up

时间窗: At 1-week follow-up

The number of participants in the experimental group who complete the intervention divided by the number of participants randomized into the group

Missing data at baseline

时间窗: At baseline

The percentage of missing in the dataset

Missing data at 1-week follow-up

时间窗: At 1-week follow-up

The percentage of missing in the dataset

Missing data at 3-month follow-up

时间窗: At 3-month follow-up

The percentage of missing in the dataset

Adverse events at 1-week follow-up

时间窗: At 1-week follow-up

unfavorable and unintended events

Intervention attendance rate

时间窗: Immediately after the training workshop

The number of participants in the experimental group who complete the intervention divided by the number of participants randomized into the group

Adherence to the intervention protocol at 1-week follow-up

时间窗: At 1-week follow-up

The number of participants in the experimental group who practice the skills gained divided by the number of participants randomized into the group

Adverse events at 1-month follow-up

时间窗: At 1-month follow-up

unfavorable and unintended events

Adverse events at 3-month follow-up

时间窗: At 3-month follow-up

unfavorable and unintended events

Missing data at 1-month follow-up

时间窗: At 1-month follow-up

The percentage of missing in the dataset

Missing data at 6-month follow-up

时间窗: At 6-month follow-up

The percentage of missing in the dataset

Adverse events at 6-month follow-up

时间窗: At 6-month follow-up

unfavorable and unintended events

次要结局

  • Chinese version of the Pediatric Quality of Life Inventory at 6-month follow-up(At 6-month follow-up)
  • Chinese version of The Center for Epidemiologic Studies Depression Scale for Children at 6-month follow-up(At 6-month follow-up)
  • Chinese version of the Rosenberg Self-esteem Scale at 6-month follow-up(At 6-month follow-up)

研究者

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

Dr Eva Ho

Assistant Professor

The Hong Kong Polytechnic University

研究点 (2)

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