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Completed

NCT Number: NCT06170996

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder (ADHD) Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wuhan Mental Health Centre

Wuhan, Hubei, 430022, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-based behavioral parent training (I-BPT)

Behavioral

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

Primary outcomes

  1. Chinese version of Swan-son Nolan and Pelham, Version IV Scale-parent form (SNAP-IV)

    Time frame: From baseline to 2 months

    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.

  2. Weiss Functional Impairment Scale-Parent form (WFIRS-P)

    Time frame: From baseline to 2 months

    This scale consists of 50 items, each with a score ranging from 0 to 3, a higher average score indicates a greater impairment.

Secondary outcomes

  1. Screen for Child Anxiety Related Emotional Disorders (SCARED)

    Time frame: From baseline to 2 months

    This scale encompasses 41 items, each item ranges from 0 to 2, with a higher score indicating more severe anxiety symptoms.

  2. Children's Depression Inventory-Short Form (CDI-S)

    Time frame: From baseline to 2 months

    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.

  3. The seven-item version of the Generalized Anxiety Disorder (GAD-7)

    Time frame: From baseline to 2 months

    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.

  4. The nine-item version of the Patient Health Questionnaire (PHQ-9)

    Time frame: From baseline to 2 months

    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.

  5. Parenting Stress Index-Short Form (PSI-SF)

    Time frame: From baseline to 2 months

    This scale consists of 15 items, with a total score from 15 to 75. The higher score indicates more higher stress level.

  6. Client Satisfaction Questionnaire adapted to Internet-based interventions (CSQ-I)

    Time frame: posttest: 2 months to pretest

    The CSQ-I consists of 8 items, with a total score of 0 to 32. The higher scores correspond to greater satisfaction of participants.

Sponsors and collaborators

Lead sponsor

Wuhan Mental Health Centre

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 14, 2023
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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