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Clinical Trials/NCT03662867
NCT03662867CompletedNot Applicable

Application of Mindfulness Training in a Family-based Intervention for Improving Early Child Development and Stress Management in Economically Disadvantaged Families

The Hong Kong Polytechnic University1 site in 1 country102 target enrollmentStarted: January 22, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
102
Locations
1
Primary Endpoint
Change from Baseline Child Cognitive Development and Behaviour Regulation at 8 weeks

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
5 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Family-based mindfulness intervention

Experimental

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.

Intervention: Family-based mindfulness intervention (Behavioral)

Wait-list control

Other

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.

Intervention: Wait-list (Other)

Outcomes

Primary Outcomes

Change from Baseline Child Cognitive Development and Behaviour Regulation at 8 weeks

Time Frame: (1) Pretest baseline, and (2) through intervention completion, 8 weeks

Assessed by counting test and head-shoulder-knee-toe test

Secondary Outcomes

  • Change from Baseline Child Attention at 8 weeks and at 3 months((1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion)
  • Change from Baseline Parental Stress at 8 weeks and at 3 months((1) Pretest baseline, and (2) 3-month follow up after intervention completion)
  • Change from Baseline Parent Depression at 8 weeks and at 3 months((1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion)
  • Change from Baseline Physiological Stress indicated by salivary cortisol at 8 weeks((1) Pretest baseline, (2) through intervention completion, 8 weeks)
  • Change from Baseline Family Functioning at 8 weeks and at 3 months((1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion)
  • Change from Baseline Mindfulness in Parenting at 8 weeks and at 3 months((1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion)
  • Change from Baseline Physiological Stress indicated by heart rate variability at 8 weeks and at 3 months((1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion)
  • Change from Baseline Child Behavior Problem at 8 weeks and at 3 months((1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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