Clinical trial NCT06170996: Internet-Based Behavioural Parent Training Intervention for Children With Attention Deficit/Hyperactivity Disorder
Official title: Internet-Based Behavioural Parent Training Intervention for Children With Attention-Deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: Attention deficit hyperactivity disorder
Lead sponsor: Wuhan Mental Health Centre
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Chinese version of Swan-son Nolan and Pelham, Version IV Scale-parent form (SNAP-IV)
timeFrame: From baseline to 2 months
measure: Weiss Functional Impairment Scale-Parent form (WFIRS-P)
timeFrame: From baseline to 2 months
Secondary outcomes:
measure: Screen for Child Anxiety Related Emotional Disorders (SCARED)
timeFrame: From baseline to 2 months
measure: Children's Depression Inventory-Short Form (CDI-S)
timeFrame: From baseline to 2 months
measure: The seven-item version of the Generalized Anxiety Disorder (GAD-7)
timeFrame: From baseline to 2 months
measure: The nine-item version of the Patient Health Questionnaire (PHQ-9)
timeFrame: From baseline to 2 months
measure: Parenting Stress Index-Short Form (PSI-SF)
timeFrame: From baseline to 2 months
measure: Client Satisfaction Questionnaire adapted to Internet-based interventions (CSQ-I)
timeFrame: posttest: 2 months to pretest
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Mental Health Centre
state: Hubei
Study officials:
affiliation: director in Child and Adolescent Psychological Ward of Wuhan Mental Health Center
name: Tang Jun, Master
role: STUDY_DIRECTOR
References: