Mental Health IssueMPHKCNCT04427683
Effects of a Brief Mindful Parenting Program for Hong Kong Chinese Impacted by Social Unrest
A study testing Brief mindful parenting program in people with Mental Health Issue, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
A four session mindful parenting workshop is designed to promote parental mental health during the social unrest in 2020. This study is conducted to investigate the outcome of the program. It is a randomised control trial design and will be conducted in five sites in Hong Kong. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Brief mindful parenting program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 May 2020to 30 Sep 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- parents of adolescents at aged between 10 to 21
- a score of PHQ-9 of 2 or above
Who cannot join
- parents with self-reported psychosis, alcohol or substance abuse, individual or family crisis in last six months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Brief Mindful Parenting Program for Hong Kong Chinese Impacted by Social Unrest: A Randomised Trial
A four session mindful parenting workshop is designed to promote parental mental health during the social unrest in 2020. This study is conducted to investigate the outcome of the program. It is a randomised control trial design and will be conducted in five sites in Hong Kong. An estimated 340 parents will be recruited and randomised into an intervention group and a wait-list control group. The primary outcome is parental depression. Secondary outcomes include parental anxiety and post-traumatic stress, negative emotions, family functioning, family conflict and mindful parenting. Exposure to social unrest will be measured and the relationship to mental health and effects of the program will be examined.
Read the detailed description
Design: With a self-administered screening for depression (PHQ-9), parents with a subclinical cutoff score or above will be eligible to participate in a four-session parent workshop. The same program will be provided in five locations in Hong Kong. A waitlist-control randomised controlled trial will be used to evaluate the outcomes of the program. An estimated 340 parents will be recruited and randomised into an intervention group and a wait-list control group. The sample estimation is based on an expected effect size of .33 for family functioning in the PI's pilot study, with an estimated drop-out rate of 15%, a two-tailed α error of 5%, 80% power, and a test of two independent groups.
Measures: (1) Exposure to social unrest will be measured using the Political Life Events Scale. The scale contains 20 items related to stressful events, to which respondents report exposure by answering yes or no. In view of the local context, only 16 items will be used. (2) Negative emotions about social unrest will be measured by the three items developed by Halperin et al. The items assess the intensity of negative emotions (hatred, anger, despair) in the context of social unrest, with responses given on a Likert-type scale ranging from 1 (not at all) to 10 (very strong). (3) Depression and anxiety symptoms will be assessed by the Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorder 7-item (GAD-7) scale. (4) Traumatic stress will be assessed by the International Trauma Questionnaire (ITQ), a 6-item self-report measure of the major symptoms of post-traumatic stress. The ITQ has been translated into Chinese and validated for screening of post-traumatic stress. (5) Family functioning will be assessed by the Family APGAR (Adaptation, Partnership, Growth, Affection, Resolve) scale (APGAR). The 5-item scales uses a 3-point response scale (0 = hardly ever and 2 = almost always). A cutoff for severe family dysfunction is available for Chinese families. (6) Family conflict will be measured by the Conflict Tactics Scale (CTS-2), a self-report measure of behavioural assault or psychological aggression among family members. It has been used in studies of conflict between adolescents and parents.
- Conditions
- Mental Health Issue
- Being tested
- Brief mindful parenting program
- Keywords
- parent depression, parent mental health, mindfulness-based intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief mindful parenting programBehavioural
Mindfulness exercise include formal and informal mindfulness exercises, and additional exercise for coping with anger and arousing emotions. Psychoeducation includes understanding relationship between thoughts and feelings, fight or flight responses and adaptive coping in parenting relationship.
| Study group | Role | What they receive |
|---|---|---|
| Brief mindful parenting program | Experimental | The program will consist of a four-session and last for eight hours integrating mindfulness skills and psychoeducation in managing stress under social unrest and promoting strategies for emotion regulation, conflict management, and self-care. Receives: Behavioral: Brief mindful parenting program |
| Wait-list control group | Other | A four-minute educational video will be distributed to the participants who accept the randomisation. It includes brief information on mental health. After the participants from experimental group complete the intervention, those in wait-list control group will receive the same intervention. Receives: Behavioral: Brief mindful parenting program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Self-administered measure Patient Health Questionnaire (PHQ-9), 9 items, sum of scores range from 0 to 27, the higher the score, the more severe in depressive symptoms
Measured: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
Secondary outcomes (5)
Anxiety
Self-administered measure Generalized Anxiety Disorder 7-item scale (GAD-7), 7 items, sum of scores from 0 to 21, the higher the score, the more severe in the anxiety symptoms
Measured: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
Post-traumatic stress
self-administered measure International Trauma Questionnaire (ITQ), 6 items, sum of scores range from 0 to 24, the higher the score, the more severe the post-traumatic stress symptoms
Measured: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
family functioning
self-administered measure Family APGAR (Adaptation, Partnership, Growth, Affection, Resolve) scale (APGAR), 5 items, sum of the scores range from 0 to 10, the higher the score, the better in family functioning
Measured: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
family conflict
self-administered measure Conflict Tactics Scale (CTS-2), 16 items, sum of scores range from 0 to 112, the higher the score, the more stronger intensity the family conflict is
Measured: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
mindful parenting
self administered measure, Interpersonal Mindfulness in Parenting scale, 6 items in nonjudgmental acceptance in parenting and 4 items in listening with full attention, sum of scores range from 6 to 30 for nonjudgmental acceptance in parenting, and 6 to 20 for listening with full attention, the higher the score, the stronger the interpersonal mindfulness level is
Measured: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start15 May 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
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 Mental Health IssueStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Recruited and eligible participants will be randomised into an intervention group and a wait-list control group.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herman, Hay-ming LO, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427683
- Sponsor's protocol ID
- SR2020.A6.004
- Acronym
- MPHKC
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2020
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The protocol will be published in an open access academic journal.
Publications
Lo HHM, Lau ENS, Tam CHL, Ngai SW, Chan SHW, Leung BFH, Wong ET, Wong EWY, Wong GOC, Cho WC, Tsang AWK, Singh NN. Effects of a Mindful Parenting Workshop for Parents of Adolescents and Young Adults Following Social Unrest in Hong Kong. Mindfulness (N Y). 2022;13(1):248-261. doi: 10.1007/s12671-021-01790-7. Epub 2021 Dec 2.
PubMed 34873419
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Brief Mindful Parenting Program for Hong Kong Chinese Impacted by Social Unrest: A Randomised Trial
- ClinicalTrials.gov ID
- NCT04427683
- Acronym / sponsor ID
- MPHKC / SR2020.A6.004
- Conditions
- Mental Health Issue
- Keywords
- parent depression, parent mental health, mindfulness-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 11 Jun 2020 (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.
A four session mindful parenting workshop is designed to promote parental mental health during the social unrest in 2020. This study is conducted to investigate the outcome of the program. It is a randomised control trial design and will be conducted in five sites in Hong Kong. An estimated 340 parents will be recruited and randomised into an intervention group and a wait-list control group. The primary outcome is parental depression. Secondary outcomes include parental anxiety and post-traumatic stress, negative emotions, family functioning, family conflict and mindful parenting. Exposure to social unrest will be measured and the relationship to mental health and effects of the program will be examined.
Detailed description
Design: With a self-administered screening for depression (PHQ-9), parents with a subclinical cutoff score or above will be eligible to participate in a four-session parent workshop. The same program will be provided in five locations in Hong Kong. A waitlist-control randomised controlled trial will be used to evaluate the outcomes of the program. An estimated 340 parents will be recruited and randomised into an intervention group and a wait-list control group. The sample estimation is based on an expected effect size of .33 for family functioning in the PI's pilot study, with an estimated drop-out rate of 15%, a two-tailed α error of 5%, 80% power, and a test of two independent groups.
Measures: (1) Exposure to social unrest will be measured using the Political Life Events Scale. The scale contains 20 items related to stressful events, to which respondents report exposure by answering yes or no. In view of the local context, only 16 items will be used. (2) Negative emotions about social unrest will be measured by the three items developed by Halperin et al. The items assess the intensity of negative emotions (hatred, anger, despair) in the context of social unrest, with responses given on a Likert-type scale ranging from 1 (not at all) to 10 (very strong). (3) Depression and anxiety symptoms will be assessed by the Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorder 7-item (GAD-7) scale. (4) Traumatic stress will be assessed by the International Trauma Questionnaire (ITQ), a 6-item self-report measure of the major symptoms of post-traumatic stress. The ITQ has been translated into Chinese and validated for screening of post-traumatic stress. (5) Family functioning will be assessed by the Family APGAR (Adaptation, Partnership, Growth, Affection, Resolve) scale (APGAR). The 5-item scales uses a 3-point response scale (0 = hardly ever and 2 = almost always). A cutoff for severe family dysfunction is available for Chinese families. (6) Family conflict will be measured by the Conflict Tactics Scale (CTS-2), a self-report measure of behavioural assault or psychological aggression among family members. It has been used in studies of conflict between adolescents and parents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Recruited and eligible participants will be randomised into an intervention group and a wait-list control group.
| Arm | Type | Receives |
|---|---|---|
| Brief mindful parenting program | Experimental | Behavioral: Brief mindful parenting programThe program will consist of a four-session and last for eight hours integrating mindfulness skills and psychoeducation in managing stress under social unrest and promoting strategies for emotion regulation, conflict management, and self-care. |
| Wait-list control group | Other | Behavioral: Brief mindful parenting programA four-minute educational video will be distributed to the participants who accept the randomisation. It includes brief information on mental health. After the participants from experimental group complete the intervention, those in wait-list control group will receive the same intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- parents of adolescents at aged between 10 to 21
- a score of PHQ-9 of 2 or above
Key exclusion criteria (1 listed)
- parents with self-reported psychosis, alcohol or substance abuse, individual or family crisis in last six months
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 |
|---|---|---|
| Brief mindful parenting programMindfulness exercise include formal and informal mindfulness exercises, and additional exercise for coping with anger and arousing emotions. Psychoeducation includes understanding relationship between thoughts and feelings, fight or flight responses and adaptive coping in parenting relationship. | Behavioural | Brief mindful parenting program, Wait-list control group |
Primary outcome
Depression
Time frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
Self-administered measure Patient Health Questionnaire (PHQ-9), 9 items, sum of scores range from 0 to 27, the higher the score, the more severe in depressive symptoms
5 secondary outcomes
Anxiety
Time frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
Post-traumatic stress
Time frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
family functioning
Time frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
family conflict
Time frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
mindful parenting
Time frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Derived from this study: PubMed 34873419Lo HHM, Lau ENS, Tam CHL, Ngai SW, Chan SHW, Leung BFH, Wong ET, Wong EWY, Wong GOC, Cho WC, Tsang AWK, Singh NN. Effects of a Mindful Parenting Workshop for Parents of Adolescents and Young Adults Following Social Unrest in Hong Kong. Mindfulness (N Y). 2022;13(1):248-261. doi: 10.1007/s12671-021-01790-7. Epub 2021 Dec 2.
- Individual participant dataSharing planned: No. The protocol will be published in an open access academic journal.
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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.
Herman, Hay-ming LO, 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 Brief mindful parenting program in people with Mental Health Issue, 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 1 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: finished, as of the sponsor's last update on 13 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).). 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 NCT04427683, 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 13 Apr 2021.