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

NCT06298136 | Recruiting

• 1 other identifier: 15610923
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

ADHD

Keywords

ADHD; family; mindfulness-based intervention; online intervention; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 3-month follow-up

Secondary Outcomes (7)

• Parent depressive symptoms

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

• Parent anxiety symptoms

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

• Parent sleep quality

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

• Parent well-being

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

• Child executive functioning

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

Study Arms (2)

Online mindfulness-based intervention (MBI)

EXPERIMENTAL

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.

Behavioral: mindfulness-based intervention

Psychoeducation

ACTIVE COMPARATOR

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.

Behavioral: child behavior management

Interventions

mindfulness-based intervention BEHAVIORAL

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

Online mindfulness-based intervention (MBI)

child behavior management BEHAVIORAL

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

Psychoeducation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Herman Hay Ming Lo

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Herman Hay Ming Lo, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Herman Hay Ming Lo, PhD

CONTACT

+85296279830; herman.lo@polyu.edu.hk

Christine Wing Tung Yeung, MSSc

CONTACT

+85266279904; wing-tung.yeung@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants will be informed that an intervention (program A or program B) will be assigned to them randomly. For research team who will be in contact with participants for outcome assessment, whether the participants have been allocated to arm 1 or arm 2 will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study will investigate the effects of an online mindfulness-based intervention (MBI) on outcomes in children with ADHD. The effects of the MBI (arm 1) will be investigated in comparison with the effects of psychoeducation (arm 2).

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 7, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The protocol will be submitted for publication within 2024. The data collected in this study will be shared after the publication of the study is published.
• Access Criteria: Individuals who request the data should indicate the purpose clearly when submitting their requests.

Locations

HK (1)