NCT04427683

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

April 13, 2021

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

June 5, 2020

Last Update Submit

April 12, 2021

Conditions

Keywords

parent depressionparent mental healthmindfulness-based intervention

Outcome Measures

Primary Outcomes (1)

  • 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

    Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).

Secondary Outcomes (5)

  • Anxiety

    Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).

  • Post-traumatic stress

    Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).

  • family functioning

    Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).

  • family conflict

    Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).

  • mindful parenting

    Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).

Study Arms (2)

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.

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.

Behavioral: Brief mindful parenting program

Interventions

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.

Brief mindful parenting programWait-list control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • parents of adolescents at aged between 10 to 21
  • a score of PHQ-9 of 2 or above

You may not qualify if:

  • parents with self-reported psychosis, alcohol or substance abuse, individual or family crisis in last six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LO, Herman Hay-ming

Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

Study Officials

  • Herman, Hay-ming LO, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Recruited and eligible participants will be randomised into an intervention group and a wait-list control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2020

First Posted

June 11, 2020

Study Start

May 15, 2020

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

April 13, 2021

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

The protocol will be published in an open access academic journal.

Locations