The Effects of an Online Mindfulness-based Intervention for Children With Attention-Deficit/Hyperactivity Disorder

ADHD Clinical Trial

— MindADHD  

Official title:

The Effects of an Online Mindfulness-based Intervention for Parents of Children With Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06298136
• Other study ID #: 15610923
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: The Hong Kong Polytechnic University
• Contact: Herman Hay Ming Lo, PhD
• Phone: +85296279830
• Email: herman.lo[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the effects of an online mindfulness-based intervention with a randomized controlled trial.

Description:

In Hong Kong, 3.9% of adolescents were diagnosed as having Attention Deficit/Hyperactivity Disorder (ADHD). The primary symptoms of ADHD include inattention, hyperactivity, and impulsivity, which limit learning and socioemotional development. ADHD has been associated with poor family functioning, increased stress within the family, higher rates of parental psychopathology, and conflicted parent-child relationships. More than 70% of children with ADHD experience improvements after treatment with psychostimulant medication but some children demonstrate side effects. Behavioral interventions have been found to be effective in enhancing motivation and decreasing the disruptive behaviors of children with ADHD. However, some parents of children with ADHD experience high levels of stress, and the children's symptoms and reactions often complicate their application of the techniques taught in parent behavioral training programs. Moreover, while children benefit from behavioral training in short-term improvements, its long-term effects are uncertain, as children with ADHD cannot learn self-regulation without parental supervision. In recent reviews and randomized controlled trials, mindfulness-based intervention (MBI) has shown its benefits in improving ADHD symptoms and parent's mental health. Practitioners and researchers have collaborated to apply technology and convert face-to-face MBIs into online or app-based MBIs. Our research team modified the ordinary MBI program structure by integrating short daily online psychoeducation videos with audio mindfulness guidance. In view of the poor engagement and high dropout issues of many online programs, our program is strengthened by incorporating four weekly, real-time online meetings with instructors. The content of MBI includes mindfulness and attention, mindfulness and physical sensation, mindfulness and parental stress, and mindfulness and self-care. The majority of the exercises are for parents, but additional guidance for child-parent mindfulness exercises is included. One module will target children with ADHD and the length of video and audio of mindfulness exercises for children. This study will investigate the effects of an online MBI, with a randomized controlled trial. A total of 208 parents will be recruited, and randomly assigned to online MBI and psychoeducation. The effects of the MBI will be investigated in comparison with the effects of psychoeducation and outcomes on child ADHD symptoms, parent mental health, and family expressed emotions will be measured. Immediate effect at post-intervention, and 6-month follow-up maintenance effect will be investigated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• parents of children diagnosed with ADHD by a psychiatrist and psychologist according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Ed (DSM-5)
• Children with ADHD aged 6 to 12.
• Parents who have served as the primary caregivers of their children in the last year and children with ADHD who speak and understand Cantonese Chinese.
• Children either not taking any medication or maintaining a stable dosage of the same ADHD medication for at least 3 months prior to study enrollment and having no plans to change medication and dosage during the study period.

Exclusion Criteria:

• parents diagnosed with developmental disabilities, psychosis, or cognitive impairment, who may thus have difficulty comprehending the content of the project.
• Children with another developmental disability such as autistic spectrum disorder or intellectual disability.
• Parents who completed an eight-week MBI or equivalent program.

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Behavioral:
• mindfulness-based intervention
Audio exercises as homework assignment will be included. Four instructor-led online real time sessions are provided
• child behavior management
worksheet will be provided to guide parents and children in behavior change. Four instructor-led online real time sessions are provided.

Locations

Country	Name	City	State
Hong Kong	Herman Hay Ming Lo	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	Child ADHD symptoms	Strengths and Weaknesses of ADHD Symptoms and Normal Behaviors rating Scale, minimum value is -54 and maximum value is 54. The higher the score, the severe the symptoms of inattention and hyperactivity.	Change from pre-intervention, to 1-month follow-up, and 6-month follow-up
Secondary	Parent depressive symptoms	The Center for Epidemiologic Studies Depression Scale. minimum value is 0 and the maximum value is 30. The higher the score, the severe the symptoms of depression.	Change from pre-intervention, to 1-month follow-up, and 6-month follow-up
Secondary	Parent anxiety symptoms	Hospital Anxiety and Depression Scale - Anxiety subscale. minimum value is 0 and the maximum value is 21. The higher the score, the severe the symptoms of anxiety.	Change from pre-intervention, to 1-month follow-up, and 6-month follow-up
Secondary	Parent sleep quality	Insomnia Severity Index. minimum value is 0 and the maximum value is 28. The higher the score, the severe the symptoms of sleep quality.	Change from pre-intervention, to 1-month follow-up, and 6-month follow-up
Secondary	Parent well-being	World Health Organization Well-Being Index. minimum value is 0 and the maximum value is 25. The lower the score, the worse in well-being.	Change from pre-intervention, to 1-month follow-up, and 6-month follow-up
Secondary	Child executive functioning	Behavior Rating Inventory of Executive Function (second edition). minimum value is 0 and the maximum value is 126. The higher the score, the severe the deficits in executive functioning.	Change from pre-intervention, to 1-month follow-up, and 6-month follow-up
Secondary	Parental Stress	Parenting Stress Index (short form). minimum value is 36 and the maximum value is 180. The higher the score, the severe the parenting stress.	Change from pre-intervention, to 1-month follow-up, and 6-month follow-up
Secondary	Expressed emotion	The Five Minute Speech Sample. It is scored by the coding procedure. There is no maximum value. THe higher the score, the severe the parent's expressed emotion.	Change from pre-intervention, to 1-month follow-up, and 6-month follow-up