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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06170996
Other study ID # KY2023.0912.02
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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