Applying Mindfulness for Economically Disadvantaged Families

NCT03662867 | Completed

• 1 other identifier: 21611415
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Keywords

mindfulness training; economically disadvantaged families; family-based interventions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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 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 salivary cortisol at 8 weeks

  (1) Pretest baseline, (2) through intervention completion, 8 weeks

• 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

Study Arms (2)

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.

Behavioral: Family-based mindfulness intervention

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.

Other: Wait-list

Interventions

Family-based mindfulness intervention 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.

Family-based mindfulness intervention

Wait-list OTHER

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

Wait-list control

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Children or parents with physical disability or mental disorders

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• University Grants Committee, Hong Kong: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, 852, Hong Kong

Location

MeSH Terms

Interventions

Waiting Lists

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Hay-ming Herman Lo, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 10, 2018
• Study Start: January 22, 2016
• Primary Completion: July 13, 2018
• Study Completion: July 13, 2018
• Last Updated: September 20, 2018

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)