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
NCT number | NCT03662867 |
Other study ID # | 21611415 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 22, 2016 |
Est. completion date | July 13, 2018 |
Verified date | September 2017 |
Source | The Hong Kong Polytechnic University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 102 |
Est. completion date | July 13, 2018 |
Est. primary completion date | July 13, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Hong Kong Polytechnic University | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The Hong Kong Polytechnic University | University Grants Committee, Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline Child Cognitive Development and Behaviour Regulation at 8 weeks | Assessed by counting test and head-shoulder-knee-toe test | (1) Pretest baseline, and (2) through intervention completion, 8 weeks | |
Secondary | Change from Baseline Parental Stress at 8 weeks and at 3 months | Assessed by parent-reported scale, named Parenting Stress Index-Short Form (PSI-SF), assessing the level of parenting stress from different sources of difficulties. Total Stress (TS) score and three sub-scores, including Parental Distress (PD), Parental-Child Dysfunctional Interaction (PCDI) and Difficult Child (DC), are reported. For the range of TS, the minimum score is 36 and the maximum score is 180. Higher values represent a higher level of total parenting stress. For the range of PD, PCDI and DC, the minimum scores are 12 and the maximum scores are 60. Higher values represent a higher level of parenting stress respectively from the source of parental distress, parental-child dysfunctional interaction, and difficult child. Three sub-scores are summed to compute a total score. |
(1) Pretest baseline, and (2) 3-month follow up after intervention completion | |
Secondary | Change from Baseline Parent Depression at 8 weeks and at 3 months | Assessed by parent-reported scale, named Patient Health Questionnaire-9 (PHQ-9), assessing the construct of parent's depression symptoms, directly based on the nine diagnostic criteria for major depressive disorder in the DSM-IV (Diagnostic and Statistical Manual Fourth Edition). One total score is reported. For the range of the total score, the minimum score is 0 and the maximum score is 27. Higher values represent parents' more severe level of depression symptoms. |
(1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion | |
Secondary | Change from Baseline Mindfulness in Parenting at 8 weeks and at 3 months | Assessed by parent-reported scale, named Interpersonal Mindfulness in Parenting (IM-P) scale, assessing the construct of parent's quality of mindfulness specific to his or her family context. The total score and four subscale scores, including Compassion for Child (CC), Emotional Awareness in Parenting (EAP), Nonjudgmental Acceptance in Parenting (NAP) and Listening with Full Awareness (LFA), are reported. The range of the total score is 23 to 115. Higher values represent parents' better quality of mindfulness in parenting. The range of CC is 7 to 35. Higher values represent parents' better quality of compassion for child. The range of EAP and NAP is 6 to 30. Higher values respectively represent parents' better quality of emotional awareness in parenting and nonjudgmental acceptance in parenting. The range of LFA is 4 to 20. Higher values represent parents' better quality of listening with full awareness. Four subscale scores are summed to compute a total score. |
(1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion | |
Secondary | Change from Baseline Physiological Stress indicated by salivary cortisol at 8 weeks | Assessed by enzyme-linked immunoassay kit | (1) Pretest baseline, (2) through intervention completion, 8 weeks | |
Secondary | Change from Baseline Physiological Stress indicated by heart rate variability at 8 weeks and at 3 months | Assessed by electrocardiogram (ECG) | (1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion | |
Secondary | Change from Baseline Family Functioning at 8 weeks and at 3 months | Assessed by parent-reported scale, named Family APGAR scale, assessing parent's satisfaction of family functions. One total score is reported. For the range of the total score, the minimum score is 0 and the maximum score is 10. Higher values represent parent's better satisfaction of family functions. |
(1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion | |
Secondary | Change from Baseline Child Behavior Problem at 8 weeks and at 3 months | Assessed by parent-reported scale, named Child Behavior Checklist (CBCL), assessing parents' ratings of their children's behavior problems. The Total Problem, and seven subscale scores, including Internalizing Problems, Externalizing Problems, Anxious/Depressed, Withdrawn/Depressed, Somatic Complaints, Attention Problems, and Aggressive Behavior, are reported. For the range of Total Problem and all subscale scores, including Internalizing Problems, Externalizing Problems, Anxious/Depressed, Withdrawn/Depressed, Somatic Complaints, Attention Problems, and Aggressive Behavior, the minimum scores are 0 and the maximum scores are 1. Higher values respectively represent children's more severe level of overall behavioral problems, Internalizing Problems, Externalizing Problems, Anxious/Depressed, Withdrawn/Depressed, Somatic Complaints, Attention Problems, and Aggressive Behavior. All of them are calculated as the sum of corresponding scale items, and standardized. |
(1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion | |
Secondary | Change from Baseline Child Attention at 8 weeks and at 3 months | Assessed by computer-aided Attention Network Test (ANT), assessing children's efficiency of attention networks according to their response time to stimuli. | (1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion |
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 |