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Pilot StudyADHDparentNCT05480423

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

A study testing Mindfulness-based intervention in people with Pilot Study, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Pilot Study
What is being tested?
Mindfulness-based intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteHong Kong
Study dates
15 Aug 2022to 15 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Hong Kong Polytechnic University

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Pilot Study on Application of Online Technology for Mindfulness-based Intervention on Parents of Children With Attention Deficit/Hyperactivity Disorder

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

Conditions
Pilot Study
Being tested
Mindfulness-based intervention
Keywords
ADHD, parent, Mindfulness-based intervention, Online
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness-based interventionBehavioural

    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
Study groups in NCT05480423
Study groupRoleWhat they receive
Online mindfulness-based interventionExperimentalThe 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.
Receives: Behavioral: Mindfulness-based intervention
Waitlist controlled groupNo interventionParticipants will be offered same intervention three months later

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up

Secondary outcomes (5)

  1. 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.

    Measured: Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up.

  2. 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.

    Measured: Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up

  3. 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.

    Measured: Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up.

  4. 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.

    Measured: Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up

  5. 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.

    Measured: Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2022
  2. Study start15 Aug 2022
  3. Primary completion15 Mar 2023
  4. Study completion15 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized controlled trial
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05480423
Sponsor's protocol ID
ADHDparent
Acronym
ADHDparent
Status last verified
Jul 2022
First submitted
27 Jul 2022
Last updated
5 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lo HHM, Lam J, Zhang ZJ, Cheung M, Chan SKC, Wong EWY, Bogels SM, Chui WH. Effects of an online mindfulness-based program for parents of children with attention deficit/hyperactivity disorder: a pilot, mixed methods study. Front Psychiatry. 2024 Apr 24;15:1376867. doi: 10.3389/fpsyt.2024.1376867. eCollection 2024.

    PubMed 38807691

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-based intervention in people with Pilot Study, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parental stress (time frame: Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05480423, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.

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