- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04875507
PPI to Promote the Psychological Well-being of Children Living in Poverty
April 12, 2022 updated by: Dr Eva Ho, The Hong Kong Polytechnic University
The Use of a Positive Psychology Intervention (PPI) to Promote the Psychological Well-being of Children Living in Poverty: a Feasibility Randomized Controlled Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Katherine Lam, PhD
- Phone Number: 27666420
- Email: kwkatlam@polyu.edu.hk
Study Contact Backup
- Name: Eva Ho, PhD
- Phone Number: 27666417
- Email: kyeva.ho@polyu.edu.hk
Study Locations
-
-
Hong Kong,China
-
Hong Kong, Hong Kong,China, Hong Kong, 000
- Recruiting
- Ka Yan Ho
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
The control group will receive no intervention.
|
|
Active Comparator: Positive psychology
The experimental group(n=60), 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Screening rate
Time Frame: At baseline
|
The number of children screened by the RA divided by the number of children available for screening during the recruitment period.
|
At baseline
|
Eligibility rate
Time Frame: At baseline
|
The number of eligible children divided by the number of screened children
|
At baseline
|
Consent rate
Time Frame: At baseline
|
The number of eligible children who consent to participate divided by the number of eligible children
|
At baseline
|
Randomization rate
Time Frame: At baseline
|
The number of children randomized to the experimental and control groups divided by the number of consenting children
|
At baseline
|
Intervention attendance rate
Time Frame: 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
|
Immediately after the training workshop
|
Intervention attendance rate at 1-week follow-up
Time Frame: 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
|
Adherence to the intervention protocol at 1-week follow-up
Time Frame: 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
|
Retention rate at 6-month follow-up
Time Frame: 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
|
Completion rate at 6-month follow-up
Time Frame: 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
|
Missing data at baseline
Time Frame: At baseline
|
The percentage of missing in the dataset
|
At baseline
|
Missing data at 1-week follow-up
Time Frame: At 1-week follow-up
|
The percentage of missing in the dataset
|
At 1-week follow-up
|
Missing data at 1-month follow-up
Time Frame: At 1-month follow-up
|
The percentage of missing in the dataset
|
At 1-month follow-up
|
Missing data at 3-month follow-up
Time Frame: At 3-month follow-up
|
The percentage of missing in the dataset
|
At 3-month follow-up
|
Missing data at 6-month follow-up
Time Frame: At 6-month follow-up
|
The percentage of missing in the dataset
|
At 6-month follow-up
|
Adverse events at baseline
Time Frame: At baseline
|
unfavorable and unintended events
|
At baseline
|
Adverse events at 1-week follow-up
Time Frame: At 1-week follow-up
|
unfavorable and unintended events
|
At 1-week follow-up
|
Adverse events at 1-month follow-up
Time Frame: At 1-month follow-up
|
unfavorable and unintended events
|
At 1-month follow-up
|
Adverse events at 3-month follow-up
Time Frame: At 3-month follow-up
|
unfavorable and unintended events
|
At 3-month follow-up
|
Adverse events at 6-month follow-up
Time Frame: At 6-month follow-up
|
unfavorable and unintended events
|
At 6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chinese version of the Rosenberg Self-esteem Scale at 6-month follow-up
Time Frame: At 6-month follow-up
|
Assess participants' self-esteem
|
At 6-month follow-up
|
Chinese version of the Pediatric Quality of Life Inventory at 6-month follow-up
Time Frame: At 6-month follow-up
|
Assess participants' quality of life
|
At 6-month follow-up
|
Chinese version of The Center for Epidemiologic Studies Depression Scale for Children at 6-month follow-up
Time Frame: At 6-month follow-up
|
Assess participants' depressive symptoms
|
At 6-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Eva Ho, PhD, The Hong Kong Polytechnic University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2021
Primary Completion (Anticipated)
August 30, 2023
Study Completion (Anticipated)
August 30, 2023
Study Registration Dates
First Submitted
April 20, 2021
First Submitted That Met QC Criteria
May 3, 2021
First Posted (Actual)
May 6, 2021
Study Record Updates
Last Update Posted (Actual)
April 19, 2022
Last Update Submitted That Met QC Criteria
April 12, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- PPI_poverty
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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