Internet-Assisted Behavioral Parent Training Intervention for Children With Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

Official title:

Internet-Assisted Behavioral Parent Training Intervention for Children With Attention Deficit Hyperactivity Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06170996
• Other study ID #: KY2023.0912.02
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: December 2023
• Source: Wuhan Mental Health Centre
• Contact: Wu Xufang
• Phone: 15827376514
• Email: m202175546[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

In the two-arm, parallel, randomised controlled design, patients aged 6-12 years who met the DSM-IV diagnostic criteria for ADHD were recruited and randomised into Internet-Assisted behavioral parent training group or General clinical care group. The GCC group was subjected to General clinical care for 2 months, delivered by experienced child psychiatrists. The IA-BPT group received Internet-Assisted behavioral parent training in group format for 2 months besides General clinical care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)
• Hyperkinesis

Intervention

Behavioral:
• Internet-Assisted behavioral parent training (IA-BPT)
Internet-Assisted behavioral parent training in group format, 8 sessions over 2 months, delivered by systematically trained and supervised psychologists.

Locations

Country	Name	City	State
China	Wuhan Mental Health Centre	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Mental Health Centre

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chinese version of Swan-son Nolan and Pelham,Version IV Scale-parent form (SNAP-IV)	Measure of child Adhd-symptoms change from baseline to 2 months	From baseline to 2 months
Primary	Strengths & Difficulties Questionnaire(SDQ)	To measure child behavioral problems change from baseline to 2 months	From baseline to 2 months
Primary	Weiss Functional Im- pairment Rating Scales(WFIRS)	To measure child Social functioning change from baseline to 2 months	From baseline to 2 months
Secondary	Screen for Child Anxiety Related Emotional Disorders (SCARED)	To measure child anxiety symptoms change from baseline to 2 months	From baseline to 2 months
Secondary	Children's Depression Inventory-Short Form (CDI-S)	To measure child depression symptoms change from baseline to 2 months	From baseline to 2 months
Secondary	The seven-item version of the Generalized Anxiety Disorder (GAD-7)	To measure parental anxiety symptoms change from baseline to 2 months	From baseline to 2 months
Secondary	The nine-item version of the Patient Health Questionnaire (PHQ-9)	To measure parental depression symptoms change from baseline to 2 months	From baseline to 2 months
Secondary	Parenting Stress Index-Short Form (PSI-SF)	To measure parental parenting stress change from baseline to 2 months	From baseline to 2 months
Secondary	Client Satisfaction Questionnaire (CSQ)	To measure parental satisfaction with the intervention	posttest: 2 months to pretest