Clinical trial NCT05480423: Online Mindfulness-based Intervention on Parents of Children With Attention Deficit/Hyperactivity Disorder
Official title: A Pilot Study on Application of Online Technology for Mindfulness-based Intervention on Parents of Children With Attention Deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pilot Study
Keywords: ADHD
parent
Mindfulness-based intervention
Online
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project apply curriculum of online programme materials and structure for mindful parenting and caregiving. It will include four modules (introductory mindfulness, mindful parenting, applying mindfulness in challenging moments, and advanced exercises for parents of children with special needs). Each module will include short psychoeducation videos and audio mindfulness exercises that can be used in various web-based or application-based platforms. A set of videos and audio exercises will be produced for the core program materials. One study of online mindful parenting program reported a low completion rate below 30%, showing the significance of weekly video or phone contact by professionals in program engagement. Although web-based or application-based mindfulness intervention have become popular, very limited effort has been developed for applying mindfulness in parenting and caregiving using technology. Only two published studies on online mindfulness-based intervention for parents are identified. Objectives of the study are: 1. Investigate the effects of online mindfulness-based intervention for parents of children with Attention Deficit/Hyperactivity Disorder. 2. Validate the protocol of the programme and explore the needs to make refinements of the programme based on the quantitative outcome and qualitative interview analyses


Eligibility criteria: Inclusion Criteria:

* parents whose children are between 6 and 18 years old and diagnosed with Attention Deficit/Hyperactivity Disorder
* parents can understand and speak Cantonese Chinese, and
* participants should be the primary caretaker of the children in the last one year

Exclusion Criteria:

* parents who were diagnosed with psychosis, developmental disabilities, or cognitive impairment, which may present difficulties in comprehending the content of the program,
* parents have had prior experience in any 8-week Mindfulness-Based Stress Reduction/Mindfulness-Based Cognitive Therapy or equivalent program.

Primary outcomes:
measure: Parental stress
timeFrame: Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up
Secondary outcomes:
measure: Parent Anxiety
timeFrame: Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up.
measure: Parent depression
timeFrame: Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up
measure: Family Functioning
timeFrame: Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up.
measure: Parent Quality of Sleep
timeFrame: Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up
measure: Child Attention Deficit/Hyperactivity Disorder (ADHD) symptomology
timeFrame: Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Polytechnic University
Study officials:
affiliation: Hong Kong Polytechnic University
name: Herman Hay Ming Lo, PhD
role: PRINCIPAL_INVESTIGATOR
References: