Clinical trial NCT03662867: Applying Mindfulness for Economically Disadvantaged Families
Official title: Application of Mindfulness Training in a Family-based Intervention for Improving Early Child Development and Stress Management in Economically Disadvantaged Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: mindfulness training
economically disadvantaged families
family-based interventions
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: University Grants Committee, Hong Kong
First posted: 2018-09-10
Enrollment: 102
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from Baseline Child Cognitive Development and Behaviour Regulation at 8 weeks
timeFrame: (1) Pretest baseline, and (2) through intervention completion, 8 weeks
Secondary outcomes:
measure: Change from Baseline Parental Stress at 8 weeks and at 3 months
timeFrame: (1) Pretest baseline, and (2) 3-month follow up after intervention completion
measure: Change from Baseline Parent Depression at 8 weeks and at 3 months
timeFrame: (1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion
measure: Change from Baseline Mindfulness in Parenting at 8 weeks and at 3 months
timeFrame: (1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion
measure: Change from Baseline Physiological Stress indicated by salivary cortisol at 8 weeks
timeFrame: (1) Pretest baseline, (2) through intervention completion, 8 weeks
measure: Change from Baseline Physiological Stress indicated by heart rate variability at 8 weeks and at 3 months
timeFrame: (1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion
measure: Change from Baseline Family Functioning at 8 weeks and at 3 months
timeFrame: (1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion
measure: Change from Baseline Child Behavior Problem at 8 weeks and at 3 months
timeFrame: (1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion
measure: Change from Baseline Child Attention at 8 weeks and at 3 months
timeFrame: (1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Hay-ming Herman Lo, PhD
role: PRINCIPAL_INVESTIGATOR
References: