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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Hong Kong
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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