- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06950866
Home-Based Executive Function Training Intervention For Attention-Deficit/ Hyperactivity Disorder-prone Children
April 22, 2025 updated by: Wuhan Mental Health Centre
This study aims to investigate the effectiveness of a home-based executive function training Intervention on children's ADHD symptoms, executive function and parents' parenting stress.
Study Overview
Status
Not yet recruiting
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 1.SNAP-IV scale, inattention or hyperactivity-impulsivity scale score > 1.2
- 2.Parents who could understand or lacking of access to computers and the Internet
- 3.Parents can commit to ensuring full participation and complete the training and test evaluations in full compliance with the researcher's requirements
- 4.Children and their parents consent to the study
Exclusion Criteria:
- 1.Children or parents with severe organic encephalopathy and other severe mental disorders
- 2.Parents or children are receiving ADHD-related behavioral treatment
- 3.Parents or children who dropped out before the study started or in the middle of the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
|
Parents receive a 2-week, 20-session online child executive function training program, delivered by a systematically trained and supervised therapist.
After the postintervention data collection, parents in the waitlist group receive a 2-week, 20-session online child executive function training program, delivered by a systematically trained and supervised therapist.
|
|
Other: Waitlist group
|
Parents receive a 2-week, 20-session online child executive function training program, delivered by a systematically trained and supervised therapist.
After the postintervention data collection, parents in the waitlist group receive a 2-week, 20-session online child executive function training program, delivered by a systematically trained and supervised therapist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1.Chinese version of Swan-son Nolan and Pelham, Version IV Scale-parent form (SNAP-IV)
Time Frame: Baseline, 1 month after intervention, 2 months after intervention
|
This questionnaire is used to evaluate the children's ADHD symptoms.
|
Baseline, 1 month after intervention, 2 months after intervention
|
|
2.Behavior Rating Inventory of Executive Function (BRIEF)
Time Frame: Baseline, 1 month after intervention, 2 months after intervention
|
This questionnaire is used to evaluate the children's executive function.
|
Baseline, 1 month after intervention, 2 months after intervention
|
|
3.Parenting Stress Index-Short Form (PSI-SF)
Time Frame: Baseline, 1 month after intervention, 2 months after intervention
|
This questionnaire is used to evaluate the parents' parenting stress.
|
Baseline, 1 month after intervention, 2 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
4.Client Satisfaction Questionnaire (CSQ)
Time Frame: Baseline, 1 month after intervention, 2 months after intervention
|
This questionnaire is used to evaluate the parents' satisfaction with the intervention.
|
Baseline, 1 month after intervention, 2 months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2025
Primary Completion (Estimated)
September 1, 2025
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
April 22, 2025
First Submitted That Met QC Criteria
April 22, 2025
First Posted (Actual)
April 30, 2025
Study Record Updates
Last Update Posted (Actual)
April 30, 2025
Last Update Submitted That Met QC Criteria
April 22, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY2024.0710.15
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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