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

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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
• Intervention / Treatment: Behavioral: Internet-based behavioral parent training (I-BPT)

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Mental Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chinese version of Swan-son Nolan and Pelham, Version IV Scale-parent form (SNAP-IV)	This questionnaire consists of two symptom domains: inattention (9 items) and hyperactivity/impulsivity (9 items). Each item of SNAP-IV assigned a score from 0 (never or rarely) to 3 (very often), with a higher score indicating more severe ADHD symptoms.	From baseline to 2 months
Weiss Functional Impairment Scale-Parent form (WFIRS-P)	This scale consists of 50 items, each with a score ranging from 0 to 3, a higher average score indicates a greater impairment.	From baseline to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screen for Child Anxiety Related Emotional Disorders (SCARED)	This scale encompasses 41 items, each item ranges from 0 to 2, with a higher score indicating more severe anxiety symptoms.	From baseline to 2 months
Children's Depression Inventory-Short Form (CDI-S)	The CDI-S consists of 10 items, each scored with 0, 1, or 2 points. Depression is rated on a scale of 0 to 15; higher scores indicate more serious symptoms of depression.	From baseline to 2 months
The seven-item version of the Generalized Anxiety Disorder (GAD-7)	The GAD is a 7-item self-reported questionnaire, with a total score ranging from 0 to 21, and a higher score indicating increased anxiety.	From baseline to 2 months
The nine-item version of the Patient Health Questionnaire (PHQ-9)	The PHQ-9 scale comprises nine items, assigning scores from 0 (not at all) to 3 (nearly every day). The total score of the PHQ-9 questionnaire ranged from 0 to 27, with a higher score indicating more severe depressive symptoms.	From baseline to 2 months
Parenting Stress Index-Short Form (PSI-SF)	This scale consists of 15 items, with a total score from 15 to 75. The higher score indicates more higher stress level.	From baseline to 2 months
Client Satisfaction Questionnaire adapted to Internet-based interventions (CSQ-I)	The CSQ-I consists of 8 items, with a total score of 0 to 32. The higher scores correspond to greater satisfaction of participants.	posttest: 2 months to pretest

Collaborators and Investigators

• Sponsor: Wuhan Mental Health Centre
• Investigators: Study Director: Tang Jun, Master, director in Child and Adolescent Psychological Ward of Wuhan Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Attention deficit hyperactivity disorder
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: KY2023.0912.02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No