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

Pilot Study Clinical Trial

— ADHDparent  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05480423
• Other study ID #: ADHDparent
• Status: Completed
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: March 15, 2023

Study information

• Verified date: July 2022
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Pilot Study

Intervention

Behavioral:
• Mindfulness-based intervention
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

Locations

Country	Name	City	State
Hong Kong	Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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.
Secondary	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
Secondary	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.