Adolescent DevelopmentNCT04875507
PPI to Promote the Psychological Well-being of Children Living in Poverty
A study testing Positive Psychology in people with Adolescent Development, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Development
- What is being tested?
- Positive Psychology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2021to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age from 13-17
- Can read Chinese and speak Cantonese
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Ka Yan Ho
Hong Kong, Hong Kong,China, 000
Ka Yan Ho, PhD, 27666417, kyeva.ho@polyu.edu.hk
About this study
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
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.
Read the 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.
- Conditions
- Adolescent Development
- Being tested
- Positive Psychology
- Keywords
- Poverty, Positive Psychology, Depressive symptoms, Self-esteem, Quality of life
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive PsychologyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Positive psychology | Active comparator | 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. Receives: Behavioral: Positive Psychology |
| Control | No intervention | The control group will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening rate
The number of children screened by the RA divided by the number of children available for screening during the recruitment period.
Measured: At baseline
Eligibility rate
The number of eligible children divided by the number of screened children
Measured: At baseline
Consent rate
The number of eligible children who consent to participate divided by the number of eligible children
Measured: At baseline
Randomization rate
The number of children randomized to the experimental and control groups divided by the number of consenting children
Measured: At baseline
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
Measured: Immediately after the training workshop
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
Measured: At 1-week follow-up
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
Measured: At 1-week follow-up
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
Measured: At 6-month follow-up
Completion rate at 6-month follow-up
The number of participants who return the questionnaires divided by the number of questionnaires distributed
Measured: At 6-month follow-up
Missing data at baseline
The percentage of missing in the dataset
Measured: At baseline
Missing data at 1-week follow-up
The percentage of missing in the dataset
Measured: At 1-week follow-up
Missing data at 1-month follow-up
The percentage of missing in the dataset
Measured: At 1-month follow-up
Missing data at 3-month follow-up
The percentage of missing in the dataset
Measured: At 3-month follow-up
Missing data at 6-month follow-up
The percentage of missing in the dataset
Measured: At 6-month follow-up
Adverse events at baseline
unfavorable and unintended events
Measured: At baseline
Adverse events at 1-week follow-up
unfavorable and unintended events
Measured: At 1-week follow-up
Adverse events at 1-month follow-up
unfavorable and unintended events
Measured: At 1-month follow-up
Adverse events at 3-month follow-up
unfavorable and unintended events
Measured: At 3-month follow-up
Adverse events at 6-month follow-up
unfavorable and unintended events
Measured: At 6-month follow-up
Secondary outcomes (3)
Chinese version of the Rosenberg Self-esteem Scale at 6-month follow-up
Assess participants' self-esteem
Measured: At 6-month follow-up
Chinese version of the Pediatric Quality of Life Inventory at 6-month follow-up
Assess participants' quality of life
Measured: At 6-month follow-up
Chinese version of The Center for Epidemiologic Studies Depression Scale for Children at 6-month follow-up
Assess participants' depressive symptoms
Measured: At 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 Dec 2021
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent DevelopmentStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Eva Ho, The Hong Kong Polytechnic University
- Investigators
- Eva Ho, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875507
- Sponsor's protocol ID
- PPI_poverty
- Status last verified
- Apr 2022
- First submitted
- 20 Apr 2021
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ho KY, Lam KKW, Bressington DT, Lin J, Mak YW, Wu C, Li WHC. Use of a positive psychology intervention (PPI) to promote the psychological well-being of children living in poverty: study protocol for a feasibility randomised controlled trial. BMJ Open. 2022 Aug 17;12(8):e055506. doi: 10.1136/bmjopen-2021-055506.
PubMed 35977772
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04875507
- Acronym / sponsor ID
- PPI_poverty
- Conditions
- Adolescent Development
- Keywords
- Poverty, Positive Psychology, Depressive symptoms, Self-esteem, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive psychology | Active comparator | Behavioral: Positive PsychologyThe 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. |
| Control | No intervention | –The control group will receive no intervention. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age from 13-17
- Can read Chinese and speak Cantonese
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive PsychologyThis 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. | Behavioural | Positive psychology |
Primary outcome
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.
Eligibility rate
Time frame: At baseline
The number of eligible children divided by the number of screened children
Consent rate
Time frame: At baseline
The number of eligible children who consent to participate divided by the number of eligible children
Randomization rate
Time frame: At baseline
The number of children randomized to the experimental and control groups divided by the number of consenting children
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
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
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
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
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
Missing data at baseline
Time frame: At baseline
The percentage of missing in the dataset
Missing data at 1-week follow-up
Time frame: At 1-week follow-up
The percentage of missing in the dataset
Missing data at 1-month follow-up
Time frame: At 1-month follow-up
The percentage of missing in the dataset
Missing data at 3-month follow-up
Time frame: At 3-month follow-up
The percentage of missing in the dataset
Missing data at 6-month follow-up
Time frame: At 6-month follow-up
The percentage of missing in the dataset
Adverse events at baseline
Time frame: At baseline
unfavorable and unintended events
Adverse events at 1-week follow-up
Time frame: At 1-week follow-up
unfavorable and unintended events
Adverse events at 1-month follow-up
Time frame: At 1-month follow-up
unfavorable and unintended events
Adverse events at 3-month follow-up
Time frame: At 3-month follow-up
unfavorable and unintended events
Adverse events at 6-month follow-up
Time frame: At 6-month follow-up
unfavorable and unintended events
3 secondary outcomes
Chinese version of the Rosenberg Self-esteem Scale at 6-month follow-up
Time frame: 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
Chinese version of The Center for Epidemiologic Studies Depression Scale for Children at 6-month follow-up
Time frame: At 6-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Derived from this study: PubMed 35977772Ho KY, Lam KKW, Bressington DT, Lin J, Mak YW, Wu C, Li WHC. Use of a positive psychology intervention (PPI) to promote the psychological well-being of children living in poverty: study protocol for a feasibility randomised controlled trial. BMJ Open. 2022 Aug 17;12(8):e055506. doi: 10.1136/bmjopen-2021-055506.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Ho, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Psychology in people with Adolescent Development, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Ho, PhD (27666417, kyeva.ho@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening rate (time frame: At baseline). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04875507, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.