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Online Mindfulness-based Intervention on Parents of Children With Attention Deficit/Hyperactivity Disorder (ADHDparent)

Primary Purpose

Pilot Study

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Mindfulness-based intervention
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pilot Study focused on measuring ADHD, parent, Mindfulness-based intervention, Online

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Online mindfulness-based intervention

Waitlist controlled group

Arm Description

The online programme lasts for 28 days. Parents will receive the links of daily mini-lectures that introduced basic principles in mindfulness and mindful parenting, audio files of guided mindfulness practice, and exercises that facilitates parents to integrate mindfulness in their daily lives. The total time spent in each session will be around 15 to 20 minutes. Weekly meeting will be arranged with mindfulness instructor and participants.

Participants will be offered same intervention three months later

Outcomes

Primary Outcome Measures

Parental stress
The Parenting Stress Index Short Form (PSI-SF) will be used to measure parental stress (Abidin, 1995; Lam, 1999). A total of 36 items covers three dimensions parental distress, parent-child dysfunctional interaction, and difficult child. Parents will rate the items on a 5-point Likert scale from strongly disagree (1) to strongly agree (5). Total score from 36 to 180. The higher the score, the higher the level of stress.

Secondary Outcome Measures

Parent Anxiety
The anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A) will be used to measure affective and behavioural symptoms of anxiety (Zigmond & Snaith, 1983). Parents will rate the items on a 4-point Likert scale from 0 to 3, with anchors varying between items (e.g., from "Very much indeed" to "Not at all"). Total score from 0 to 21. The higher the score, the higher the level of anxiety.
Parent depression
The 10-item version of the Center for Epidemiologic Studies Depression Scale (CES-D) will be used to measure affective symptoms of depression (Radloff, 1977).Parents will rate the items on a 4-point Likert scale from none of the time (0) to most of the time (3). Total score from 0 to 30. The higher the score, the higher the level of depression.
Family Functioning
The Family Adaptation, Partnership, Growth, Affection, Resolve scale (APGAR) will be used to measure the satisfaction of perceived family functioning (Smilkstein et al., 1982).Parents will rate the items on a 3-point Likert scale from hardly ever (0) to almost always (2). total score from 0 to 10. The higher the score, the higher the level of family functioning.
Parent Quality of Sleep
The self-administered version of the Insomnia Severity Index (ISI) will be used to assess sleeping quality (Morin, 1993). The 7-item scale assesses the severity of initial, middle, and late insomnia, distress about sleep difficulties, interference of insomnia with daytime functioning, and notice of sleep problems by others. Parents will rate the items on a 4-point Likert scale from not at all (0) to extremely (2). Total score 0 to 14. The higher the score, the higher the severity of sleep difficulties.
Child Attention Deficit/Hyperactivity Disorder (ADHD) symptomology
The Strengths and Weaknesses of ADHD Symptoms and Normal Behaviors (SWAN) Rating Scale will be used to measure the similarity or differences between a child's attention skills and those of the general population (Swanson et al., 2012). A total of 18 items represents a range of behavioural characteristics. Parents will be asked to compare their child to other same-age children and rate their child on a 7-point Likert scale from far below average (-3) to far above average (3). Total score from -54 to 54. The lower the score, the higher the severity of ADHD symptoms.

Full Information

First Posted
July 27, 2022
Last Updated
April 3, 2023
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT05480423
Brief Title
Online Mindfulness-based Intervention on Parents of Children With Attention Deficit/Hyperactivity Disorder
Acronym
ADHDparent
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilot Study
Keywords
ADHD, parent, Mindfulness-based intervention, Online

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online mindfulness-based intervention
Arm Type
Experimental
Arm Description
The online programme lasts for 28 days. Parents will receive the links of daily mini-lectures that introduced basic principles in mindfulness and mindful parenting, audio files of guided mindfulness practice, and exercises that facilitates parents to integrate mindfulness in their daily lives. The total time spent in each session will be around 15 to 20 minutes. Weekly meeting will be arranged with mindfulness instructor and participants.
Arm Title
Waitlist controlled group
Arm Type
No Intervention
Arm Description
Participants will be offered same intervention three months later
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based intervention
Intervention Description
1. Psychoeducation video on mindfulness and mindful parenting. 2. Audio files of mindfulness exercises including mindfulness of breath, body scan, mindful stretching, mindfulness of soles of the feet, befriending exercises. 3. Informal mindfulness exercises by applying mindfulness in daily lives
Primary Outcome Measure Information:
Title
Parental stress
Description
The Parenting Stress Index Short Form (PSI-SF) will be used to measure parental stress (Abidin, 1995; Lam, 1999). A total of 36 items covers three dimensions parental distress, parent-child dysfunctional interaction, and difficult child. Parents will rate the items on a 5-point Likert scale from strongly disagree (1) to strongly agree (5). Total score from 36 to 180. The higher the score, the higher the level of stress.
Time Frame
Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up
Secondary Outcome Measure Information:
Title
Parent Anxiety
Description
The anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A) will be used to measure affective and behavioural symptoms of anxiety (Zigmond & Snaith, 1983). Parents will rate the items on a 4-point Likert scale from 0 to 3, with anchors varying between items (e.g., from "Very much indeed" to "Not at all"). Total score from 0 to 21. The higher the score, the higher the level of anxiety.
Time Frame
Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up.
Title
Parent depression
Description
The 10-item version of the Center for Epidemiologic Studies Depression Scale (CES-D) will be used to measure affective symptoms of depression (Radloff, 1977).Parents will rate the items on a 4-point Likert scale from none of the time (0) to most of the time (3). Total score from 0 to 30. The higher the score, the higher the level of depression.
Time Frame
Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up
Title
Family Functioning
Description
The Family Adaptation, Partnership, Growth, Affection, Resolve scale (APGAR) will be used to measure the satisfaction of perceived family functioning (Smilkstein et al., 1982).Parents will rate the items on a 3-point Likert scale from hardly ever (0) to almost always (2). total score from 0 to 10. The higher the score, the higher the level of family functioning.
Time Frame
Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up.
Title
Parent Quality of Sleep
Description
The self-administered version of the Insomnia Severity Index (ISI) will be used to assess sleeping quality (Morin, 1993). The 7-item scale assesses the severity of initial, middle, and late insomnia, distress about sleep difficulties, interference of insomnia with daytime functioning, and notice of sleep problems by others. Parents will rate the items on a 4-point Likert scale from not at all (0) to extremely (2). Total score 0 to 14. The higher the score, the higher the severity of sleep difficulties.
Time Frame
Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up
Title
Child Attention Deficit/Hyperactivity Disorder (ADHD) symptomology
Description
The Strengths and Weaknesses of ADHD Symptoms and Normal Behaviors (SWAN) Rating Scale will be used to measure the similarity or differences between a child's attention skills and those of the general population (Swanson et al., 2012). A total of 18 items represents a range of behavioural characteristics. Parents will be asked to compare their child to other same-age children and rate their child on a 7-point Likert scale from far below average (-3) to far above average (3). Total score from -54 to 54. The lower the score, the higher the severity of ADHD symptoms.
Time Frame
Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herman Hay Ming Lo, PhD
Organizational Affiliation
Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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Online Mindfulness-based Intervention on Parents of Children With Attention Deficit/Hyperactivity Disorder

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