PPI to Promote the Psychological Well-being of Children Living in Poverty

Adolescent Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04875507
• Other study ID #: PPI_poverty
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: August 30, 2023

Study information

• Verified date: April 2022
• Source: The Hong Kong Polytechnic University
• Contact: Eva Ho, PhD
• Phone: 27666417
• Email: kyeva.ho[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Adolescent Development

Intervention

Behavioral:
• Positive Psychology
This intervention aim to examine the effectiveness of PPI in reducing depressive symptoms, enhancing self-esteem, and promoting quality of life among Chinese children who are living in poverty. Participants in the experimental group will receive a 1.5 hour workshop on 4 positive psychology techniques, including (1) gratitude visit/letters, (2) 3 good things, (3) you at your best, and (4) using signature strengths. A booster intervention will be given at 1-week follow-up.

Locations

Country	Name	City	State
Hong Kong	Ka Yan Ho	Hong Kong	Hong Kong,China

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening rate	The number of children screened by the RA divided by the number of children available for screening during the recruitment period.	At baseline
Primary	Eligibility rate	The number of eligible children divided by the number of screened children	At baseline
Primary	Consent rate	The number of eligible children who consent to participate divided by the number of eligible children	At baseline
Primary	Randomization rate	The number of children randomized to the experimental and control groups divided by the number of consenting children	At baseline
Primary	Intervention attendance rate	The number of participants in the experimental group who complete the intervention divided by the number of participants randomized into the group	Immediately after the training workshop
Primary	Intervention attendance rate 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	At 1-week follow-up
Primary	Adherence to the intervention protocol 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	At 1-week follow-up
Primary	Retention rate 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	At 6-month follow-up
Primary	Completion rate at 6-month follow-up	The number of participants who return the questionnaires divided by the number of questionnaires distributed	At 6-month follow-up
Primary	Missing data at baseline	The percentage of missing in the dataset	At baseline
Primary	Missing data at 1-week follow-up	The percentage of missing in the dataset	At 1-week follow-up
Primary	Missing data at 1-month follow-up	The percentage of missing in the dataset	At 1-month follow-up
Primary	Missing data at 3-month follow-up	The percentage of missing in the dataset	At 3-month follow-up
Primary	Missing data at 6-month follow-up	The percentage of missing in the dataset	At 6-month follow-up
Primary	Adverse events at baseline	unfavorable and unintended events	At baseline
Primary	Adverse events at 1-week follow-up	unfavorable and unintended events	At 1-week follow-up
Primary	Adverse events at 1-month follow-up	unfavorable and unintended events	At 1-month follow-up
Primary	Adverse events at 3-month follow-up	unfavorable and unintended events	At 3-month follow-up
Primary	Adverse events at 6-month follow-up	unfavorable and unintended events	At 6-month follow-up
Secondary	Chinese version of the Rosenberg Self-esteem Scale at 6-month follow-up	Assess participants' self-esteem	At 6-month follow-up
Secondary	Chinese version of the Pediatric Quality of Life Inventory at 6-month follow-up	Assess participants' quality of life	At 6-month follow-up
Secondary	Chinese version of The Center for Epidemiologic Studies Depression Scale for Children at 6-month follow-up	Assess participants' depressive symptoms	At 6-month follow-up