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

NCT ID: NCT06298136

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2026-12-31

Brief Summary

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

Detailed 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 3-month follow-up maintenance effect will be investigated.

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Online mindfulness-based intervention (MBI)

The research team have developed an online family MBI (arm 1) for parents and their children with ADHD. It integrates psychoeducation videos (each 3-7 minutes) with audio mindfulness exercises (each 5-15 minutes). The content includes: (1) mindfulness and attention, (2) mindfulness and physical sensation, (3) mindfulness and parental stress, and (4) mindfulness and parental self-care. The majority of the exercises in the first four modules are for parents, but five of them include guidance for child-parent mindfulness exercises. The fifth module targets children with ADHD and the length of video and audio of mindfulness exercises for children, each last 3-5 mins.

Group Type: EXPERIMENTAL

mindfulness-based intervention

Intervention Type: BEHAVIORAL

Audio exercises as homework assignment will be included. Four instructor-led online real time sessions are provided

Psychoeducation

The psychoeducation program is based on the Parent Training for Child ADHD Program developed by Russell Barkley for children with ADHD and other behavioral disorders. It includes: (1) understanding ADHD symptoms, (2) general behavior management principles, (3) positive reinforcement and attending skills, (4) the use of a reward and token system, and (5) child problem-solving skills.

Group Type: ACTIVE_COMPARATOR

child behavior management

Intervention Type: BEHAVIORAL

worksheet will be provided to guide parents and children in behavior change. Four instructor-led online real time sessions are provided.

Interventions

mindfulness-based intervention

Audio exercises as homework assignment will be included. Four instructor-led online real time sessions are provided

Intervention Type: BEHAVIORAL

child behavior management

worksheet will be provided to guide parents and children in behavior change. Four instructor-led online real time sessions are provided.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)
• parents of 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

LO Hay-ming Herman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Herman Hay Ming Lo, PhD

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Polytechnic University

Locations

Herman Hay Ming Lo

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Herman Hay Ming Lo, PhD

Role: CONTACT

herman.lo@polyu.edu.hk

+85296279830

Christine Wing Tung Yeung, MSSc

Role: CONTACT

wing-tung.yeung@polyu.edu.hk

+85266279904

Facility Contacts

Christine Wing Tung Yeung, MSsc

Role: primary

wing-tung.yeung@polyu.edu.hk

+85266279904

Other Identifiers

15610923

Identifier Type: -

Identifier Source: org_study_id