Applying Mindfulness for Economically Disadvantaged Families

NCT ID: NCT03662867

Last Updated: 2018-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-22
• Study Completion Date: 2018-07-13

Brief Summary

The purpose of this study is to assess the effectiveness of a family-based mindfulness intervention (FBMI) in reducing parental stress and promoting child adjustment. Intervention effectiveness will be tested by conducting a randomized controlled trial comparing a group receiving FBMI to a wait-list control group. Children aged five and their parents will be recruited to participate in the study. Eligible families will be recruited, stratified by level of economically disadvantage, behaviour problem scores, and parental stress, and then randomly assigned to the two groups. Intervention groups will be conducted by instructors with professional training. Children in the intervention group are expected to show improvements in cognitive and language development, behaviour problems, attention and emotional/behavior regulation, and physiological stress (reduced cortisol and heart rate variability), compared with the waitlist control group. Parents are expected to show improvements in physiological and psychological stress, and mindfulness, compared with the waitlist control group.

Detailed Description

Economic disadvantage has been found to be associated with delayed cognitive and language development, and mental health symptoms such as aggression, anxiety of children. Chronic cumulative stressors of poverty disrupt their attention, emotional and behavioural regulation, that would further lead to negative impact in early development. As their parents are also affected by stress, they often become unresponsive, harsh and inconsistent in child discipline, resulting in a chronic stress to their children. Mindfulness is defined as paying attention purposefully and non-judgmentally to the present moment. It has been shown to improve attention, promote exposure to unpleasant experiences, facilitate cognitive change, and enhance the ability to cope with life stress. Mindfulness training has been established as an evidence-based intervention for people suffering from various chronic conditions. Its application in a family context, including parents and children, is just beginning. The purpose of this study is to assess the effectiveness of a family-based mindfulness intervention (FBMI) in reducing parental stress and promoting child adjustment. Intervention effectiveness will be tested by conducting a randomized controlled trial comparing a group receiving FBMI to a wait-list control group. Children aged five and their parents will be recruited to participate in the study. Eligible families will be recruited, stratified by level of economically disadvantage, behaviour problem scores, and parental stress, and then randomly assigned to the two groups. Intervention groups will be conducted by instructors with professional training. Children in the intervention group are expected to show improvements in cognitive and language development, behaviour problems, attention and emotional/behavior regulation, and physiological stress (reduced cortisol and heart rate variability), compared with the waitlist control group. Parents are expected to show improvements in physiological and psychological stress, and mindfulness, compared with the waitlist control group. The proposed project will be the first of its kind to use mindfulness training in a family context in Hong Kong. It is also unique as it examines the effectiveness of a mindfulness-based intervention with multiple outcome measures related to stress, combining self-reported measures with biomarkers, and psychological tests. For model building and theory development, this study may shed light on assessing the change mechanisms for promoting child learning, emotional and behavioural regulation, particularly in relation to studies of stress physiology and economically disadvantaged families. The results may not only benefit in Hong Kong but also those in other Chinese societies and countries.

Conditions

Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Family-based mindfulness intervention

Family-based mindfulness intervention is a parallel-group intervention containing one parent program and one child program. The parent mindfulness program lasts for 6 weeks, one session per week, and each session lasts for 1.5 hours. The child mindfulness program lasts for 8 weeks, one session per week, and each session lasts for 1 hour. In the fourth and sixth sessions of the parent program, 30-minute joint practice of parents and children is incorporated. All sessions are implemented by qualified instructors.

Group Type: EXPERIMENTAL

Family-based mindfulness intervention

Intervention Type: BEHAVIORAL

For the parent program of family-based mindfulness intervention, the content includes: guide body scan practice; guide stretching exercise and mindful breathing; guide practice of mindfulness to breath and body; teach three-minute breathing exercise; guide joint session and let parents practice mindfulness with children; guide mindfulness practice of exploring difficulties; and teach loving-kindness practice.

For the child program, the content includes: guide mindful breathing exercise; guide mindful movement exercises; use stories of animal characters to guide body scan exercise; guide mindful eating and mindful walking exercise; tell stories about different emotions and guide discussion; guide the imagination exercise about different emotions; and guide loving-kindness practice.

Wait-list control

Intervention group participants were assessed at baseline (T1) and after the intervention (T2). Control group participants were assessed at the same time with the intervention group, and would receive the same program after posttest of intervention groups.

Group Type: OTHER

Wait-list

Intervention Type: OTHER

No intervention is given between T1 and T2. Family-based mindfulness intervention would be received after posttest of intervention groups.

Interventions

Family-based mindfulness intervention

For the parent program of family-based mindfulness intervention, the content includes: guide body scan practice; guide stretching exercise and mindful breathing; guide practice of mindfulness to breath and body; teach three-minute breathing exercise; guide joint session and let parents practice mindfulness with children; guide mindfulness practice of exploring difficulties; and teach loving-kindness practice.

For the child program, the content includes: guide mindful breathing exercise; guide mindful movement exercises; use stories of animal characters to guide body scan exercise; guide mindful eating and mindful walking exercise; tell stories about different emotions and guide discussion; guide the imagination exercise about different emotions; and guide loving-kindness practice.

Intervention Type: BEHAVIORAL

Wait-list

No intervention is given between T1 and T2. Family-based mindfulness intervention would be received after posttest of intervention groups.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Monthly household income below one half of the median of those in Hong Kong
• Children aged between 5 to 7
• Both children and at least one of their parents agreed to participate in the program

Exclusion Criteria

• Children or parents with physical disability or mental disorders

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Grants Committee, Hong Kong

OTHER_GOV

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hay-ming Herman Lo, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Countries

Hong Kong

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: Corrected according to Advisory Issues

View Document

Other Identifiers

21611415

Identifier Type: -

Identifier Source: org_study_id