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

Study Overview
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Brief Summary
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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

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

Conditions
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Pilot Study

Intervention / Treatment
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* Behavioral: Mindfulness-based intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online mindfulness-based intervention<br>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. | Behavioral: Mindfulness-based intervention<br>* 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<br>|
| No Intervention: Waitlist controlled group<br>Participants will be offered same intervention three months later | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up. | 
| 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. | Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up | 
| 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. | Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up. | 
| 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. | Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up | 
| 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. | Change from pre-intervention, to 1-month follow-up, and to 3-month follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, parent, Mindfulness-based intervention, Online