Stress Clinical Trial
Official title:
Application of Mindfulness Training in a Family-based Intervention for Improving Early Child Development and Stress Management in Economically Disadvantaged Families
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05130944 -
Feasibility of Community Psychosocial Intervention for Women
|
N/A | |
Recruiting |
NCT06079853 -
Nurse Suicide: Physiologic Sleep Health Promotion Trial
|
N/A | |
Completed |
NCT05881681 -
A Mindfulness Approach to UA for Afro-descendants
|
N/A | |
Recruiting |
NCT05449002 -
Digital Single Session Intervention for Youth Mental Health
|
N/A | |
Recruiting |
NCT04038190 -
A Behavioral Activation Intervention Administered in a College Freshman Orientation Course
|
Phase 2 | |
Completed |
NCT03931772 -
Online Automated Self-Hypnosis Program
|
N/A | |
Active, not recruiting |
NCT05998161 -
Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout
|
N/A | |
Completed |
NCT03728062 -
Mindfulness Meditation Versus Physical Exercise: Comparing Effects on Stress and Immunocompetence
|
N/A | |
Terminated |
NCT04367636 -
The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19
|
N/A | |
Recruiting |
NCT06002074 -
SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases
|
N/A | |
Recruiting |
NCT05273996 -
Predictors of Cognitive Outcomes in Geriatric Depression
|
Phase 4 | |
Completed |
NCT05245409 -
Stress, EEG, ECG, and Chiropractic
|
N/A | |
Completed |
NCT04722367 -
Being Present With Art: The Impact of Mindful Engagement With Art on Awareness and Connection
|
N/A | |
Recruiting |
NCT06273228 -
Parenting Young Children in Pediatrics
|
N/A | |
Completed |
NCT06057883 -
Effects Of A Probiotic Formulation On Stress and Skin Health in Younger Adult Females
|
Phase 2 | |
Completed |
NCT05312749 -
The Effect of Web Based Progressive Muscle Relaxation Exercise on Clinical Stress and Anxiety of Nursing Students
|
N/A | |
Completed |
NCT05063305 -
Probiotics, Immunity, Stress, and QofL
|
N/A | |
Completed |
NCT05623826 -
Feasibility and Efficacy of a Digital Training Intervention to Increase Reward Sensitivity- Imager
|
N/A | |
Completed |
NCT04013451 -
The Kiss of Kindness Study II
|
N/A | |
Withdrawn |
NCT03749278 -
Latina Friends Motivating the Soul (ALMA)
|
N/A |