Attention Deficit Hyperactivity Disorder (ADHD)NCT06170996
Internet-Based Behavioural Parent Training Intervention for Children With Attention Deficit/Hyperactivity Disorder
A study testing Internet-based behavioral parent training (I-BPT) in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Wuhan Mental Health Centre at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Internet-based behavioral parent training (I-BPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Internet-based behavioral parent training (I-BPT)
- Keywords
- Attention deficit hyperactivity disorder
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based behavioral parent training (I-BPT)Behavioural
Internet-based behavioural parent training in a group format, 8 sessions over 2 months, delivered by a systematically trained and supervised therapist.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based behavioral parent training (I-BPT+RCC) | Experimental | 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. Receives: Behavioral: Internet-based behavioral parent training (I-BPT) |
| Routine clinical care (RCC) | No intervention | Routine clinical care for 2 months, delivered by experienced child psychiatrists, including medication treatment and examinations, crisis interventions, parent counselling and support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline to 2 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: posttest: 2 months to pretest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start12 Mar 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Mental Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tang Jun, Master, Study director, director in Child and Adolescent Psychological Ward of Wuhan Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170996
- Sponsor's protocol ID
- KY2023.0912.02
- Status last verified
- Jul 2024
- First submitted
- 6 Dec 2023
- Last updated
- 19 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Based Behavioural Parent Training Intervention for Children With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT06170996
- Acronym / sponsor ID
- KY2023.0912.02
- Keywords
- Attention deficit hyperactivity disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Wuhan Mental Health CentreUniversity, hospital or other
- Study start
- 12 Mar 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based behavioral parent training (I-BPT+RCC) | Experimental | Behavioral: Internet-based behavioral parent training (I-BPT)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. |
| Routine clinical care (RCC) | No intervention | –Routine clinical care for 2 months, delivered by experienced child psychiatrists, including medication treatment and examinations, crisis interventions, parent counselling and support. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Internet-based behavioral parent training (I-BPT+RCC) |
Primary outcome
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.
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.
6 secondary outcomes
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Time frame: From baseline to 2 months
Children's Depression Inventory-Short Form (CDI-S)
Time frame: From baseline to 2 months
The seven-item version of the Generalized Anxiety Disorder (GAD-7)
Time frame: From baseline to 2 months
The nine-item version of the Patient Health Questionnaire (PHQ-9)
Time frame: From baseline to 2 months
Parenting Stress Index-Short Form (PSI-SF)
Time frame: From baseline to 2 months
Client Satisfaction Questionnaire adapted to Internet-based interventions (CSQ-I)
Time frame: posttest: 2 months to pretest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tang Jun, Master study director
director in Child and Adolescent Psychological Ward of Wuhan Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based behavioral parent training (I-BPT) in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Wuhan Mental Health Centre at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese version of Swan-son Nolan and Pelham, Version IV Scale-parent form (SNAP-IV) (time frame: From baseline to 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.