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NCT Number: NCT05480423

Online 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

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Key information

Conditions

Pilot Study Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong Kong Polytechnic University

Hong Kong

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness-based Intervention

Behavioral
  • 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 outcomes

  1. Parental stress

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

    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 outcomes

  1. Parent Anxiety

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

    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.

  2. Parent depression

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

    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.

  3. Family Functioning

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

    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.

  4. Parent Quality of Sleep

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

    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.

  5. Child Attention Deficit/Hyperactivity Disorder (ADHD) symptomology

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

    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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Acronym: ADHDparent

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 29, 2022
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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