Internet-Based Behavioural Parent Training Intervention for Children With Attention Deficit/Hyperactivity Disorder

NCT ID: NCT06170996

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-12
• Study Completion Date: 2024-01-01

Brief Summary

This study aims to investigate the effectiveness of an Internet-based behavioural parent training intervention on children's ADHD symptoms and children's and parents' mental health status.

Detailed Description

The study design was a 2-parallel-group experimental longitudinal study. Firstly, the children received a diagnostic interview by an experienced child and adolescent psychiatrist at Wuhan Mental Health Centre for confirmation of inclusion and exclusion criteria. Parents who were eligible for the inclusion criteria and interested in the internet-based behavioural Parent Training (I-BPT) program were recruited. After the assessments of ADHD symptoms and psychiatric comorbidity, participants were randomly assigned in a 1:1 ratio to either the routine clinical care (RCC) group or I-BPT+RCC group using computer-generated randomization numbers. Participants in the I-BPT+RCC group were offered 2 months (8 weeks) of internet-assisted parent training in addition to routine outpatient treatment. The RCC group initially received only routine outpatient treatment, yet, after post-follow-up assessment, they were provided with the same I-BPT intervention for ethical considerations. Both groups were followed up after intervention by electronic questionnaire.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet-based behavioral parent training (I-BPT+RCC)

Internet-based behavioural parent training in a group format in addition to routine clinical care, 8 sessions over 2 months, delivered by a systematically trained and supervised therapist.

Group Type: EXPERIMENTAL

Internet-based behavioral parent training (I-BPT)

Intervention Type: BEHAVIORAL

Internet-based behavioural parent training in a group format, 8 sessions over 2 months, delivered by a systematically trained and supervised therapist.

Routine clinical care (RCC)

Routine clinical care for 2 months, delivered by experienced child psychiatrists, including medication treatment and examinations, crisis interventions, parent counselling and support.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Internet-based behavioral parent training (I-BPT)

Internet-based behavioural parent training in a group format, 8 sessions over 2 months, delivered by a systematically trained and supervised therapist.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 1.Meeting the diagnostic criteria for ADHD in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
• 2.Total IQ greater than 70 as measured by the Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV)
• 3.Child and their parents consent to the study

Exclusion Criteria

• 1.Children or parents with severe organic encephalopathy and other severe mental disorders
• 2.Has received or is receiving behavioral treatment (parent training)
• 3.Parents who could not understand or lacking of access to computers and the Internet

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuhan Mental Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tang Jun, Master

Role: STUDY_DIRECTOR

director in Child and Adolescent Psychological Ward of Wuhan Mental Health Center

Locations

Wuhan Mental Health Centre

Wuhan, Hubei, China

Countries

China

Other Identifiers

KY2023.0912.02

Identifier Type: -

Identifier Source: org_study_id