Clinical Trials Logo

Clinical Trial Summary

Attention deficit hyperactivity disorder (ADHD) is a common chronic neurodevelopmental disorder. Around 7.2% of children around the world are suffering from ADHD, while a chinese meta-analysis shows that the prevalence is 6.28%. There is no study of ADHD prevalence have used population-based samples, and depending on Vanderbilt ADHD Diagnostic Parent Rating Scale (VADPRS), in Chongqing, China. The purpose of the study is to investigate the prevalence of ADHD in school-age children and the parenting stress of parents of ADHD children in Chongqing. According to the proportion of primary school students in the four regions of Chongqing, using stratified proportional random sampling, 6480 primary school students are proposed to be selected as the research object, and questionnaires will complete by their caregivers and class teachers. VADPRS is used to evaluate the prevalence. Caregiver strain questionnaire (CGSQ) was used to assess parenting stress. Because of the nature of ADHD and the seriousness of its consequences, the periodic estimation of the prevalence of ADHD has been a critical research aim. This study can not only evaluate the prevalence of ADHD and parenting stress of parents of children with ADHD, but also use campus screening to promote parents and teachers' understanding of ADHD and improve the treatment rate.


Clinical Trial Description

Background: Attention deficit hyperactivity disorder (ADHD) is a common chronic neurodevelopmental disorder in children. The global prevalence of ADHD in children and adolescents is about 7.2%, while a domestic meta-analysis shows that its prevalence is about 6.3%. Foreign studies have shown that the parenting stress of parents of ADHD children is significantly higher than that of normal children. Vanderbilt scale is developed according to DSM-IV ADHD diagnostic criteria and revised with the latest DSM-V. It is applicable to school-age children, including Vanderbilt ADHD diagnostic parent rating scale (VADPRS) and Vanderbilt ADHD diagnostic teachers rating scale (VADTRS). The previous single center study of our research group has verified the reliability and validity of Vanderbilt scale. At present, a domestic multi-center research is being carried out, and the scale has been used in the diagnosis of ADHD in many countries. The caregiver strain questionnaire (CGSQ) is applicable to assess the pressure of parents of children under the age of 18 due to their children's problems. The 21 items of CGSQ are divided into three dimensions to assess parenting pressure, including objective pressure, subjective internal pressure and subjective external pressure. Likert grade 5 score is adopted, with a total score of 21 ~ 105, The higher the score, the greater the parenting pressure of caregivers. Relevant studies have confirmed that the questionnaire can be used to evaluate the parenting pressure of parents of ADHD children. The children's sleep habits questionnaire (CSHQ) is compiled on the basis of referring to the international classification of sleep problems/disorders. It is applicable to the ages of 4 ~ 12 years. The 35 items of CSHQ (33 of which enter the scoring system) have 8 levels, reflecting the common sleep problems/disorders of children, which are filled in by the guardian according to the typical sleep performance of children in recent half a year, The total score of CSHQ ≥ 41 indicates that it is a sleep problem/disorder. One research showed that the measurement performance of CSHQ in the evaluation of sleep status of school-age children in China is relatively stable. Objective and significance: To understand the positive rate and difference of VADPRS and VADTRS among school-age children in Chongqing; To understand the parenting stress of children with VADPRS positive. At present, domestic pay less attention to the parenting pressure of ADHD children's parents, and these parents have not received social support. The significance of this study is to kown the prevalence of ADHD in Chongqing, improve parents' and teachers' understanding of ADHD, finally improve the treatment rate of ADHD, and hope to give rise to more attention to the parenting pressure of parents of ADHD children in China. Research design: The sample size of primary school students in Chongqing is randomly divided into four regions according to the proportion of each region. The parents' questionnaire includes basic information, VADPRS, CSHQ and CGSQ, and the teachers' questionnaire includes basic information and VADTRS. Sample size calculation: the minimum sample size calculation formula is adopted N=μα2×π×(1-π)/δ2 The sample confirmation: According to the existing literature at home and abroad, the prevalence of ADHD in children and adolescents (π≈ 7%) is the basis for determining the sample size and allowable error(δ) = 0.15 π, α =0.05, μα=1.96 Sample size required: N=1.962×0.07×(1-0.07)/(0.07×0.15)2=2268 Assuming that the response rate is 70%, the expanded sample size is 3240. Because the stratified cluster random sampling method is adopted in this study, the sample size is doubled and 6480 people should be investigated. Statistical analysis: All the data are analyzed using SPSS 26.0; The statistics adopt two-sided test, and the test level is 0.05. Continuous variables that conform to the normal distribution are described by mean ± standard deviation, those don't conform to the normal distribution are described by median (first and third quartiles), and the number of use cases (percentage) of classified variables are described; Paired t-test or Wilcoxon signed rank sum test were used for the comparison of paired data Ethical matters and data protection: The parents and teachers of school-age students participated in the study will sign the informed consent. And this study was approved by the local ethics committee. Every participated student has a only code then the research data will be provided to the researcher. The authorization from parents on the patient's health information remains valid until the study is completed. After that, researchers will delete private information from the study record. ;


Study Design


Related Conditions & MeSH terms

  • ADHD
  • Attention Deficit Disorder with Hyperactivity

NCT number NCT05231902
Study type Observational
Source Children's Hospital of Chongqing Medical University
Contact Li Chen, doctor
Phone 136 7762 0103
Email chenli2012@126.com
Status Recruiting
Phase
Start date June 1, 2021
Completion date June 30, 2023

See also
  Status Clinical Trial Phase
Completed NCT03148782 - Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase N/A
Recruiting NCT06038942 - Formal Versus Informal Mindfulness Among University Students With Self-reported ADHD, Nonsuicidal Self-injury, or Stress N/A
Not yet recruiting NCT06456372 - Digital Health Intervention for Children With ADHD N/A
Completed NCT05518435 - Managing Young People With ADHD in Primary Care Study
Active, not recruiting NCT04978792 - Does Cultivating Self-compassion Improve Resilience to Criticism and Improve Mental Health in Adults With ADHD? N/A
Completed NCT03216512 - Effects of Noise Cancelling Headphones on Neurocognitive and Academic Outcomes in ADHD N/A
Not yet recruiting NCT02906501 - Effect of Risperidone on Cognitive Functions in Adolescents With ADHD and Behavioral Disturbances N/A
Completed NCT02829528 - Little Flower Yoga for Kids: Evaluation of a Yoga and Mindfulness Program for Children With Increased Levels of Emotion Dysregulation and Inattention N/A
Completed NCT02900144 - Modified Comprehensive Behavioral Intervention for Tics (M_CBIT) N/A
Completed NCT02562469 - ACTIVATE: A Computerized Training Program for Children With ADHD N/A
Terminated NCT02271880 - Improving Medication Adherence in ADHD Adolescents N/A
Recruiting NCT02255565 - Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study Phase 4
Completed NCT02463396 - Mindfulness Training in Adults With ADHD N/A
Terminated NCT01733680 - Amiloride Hydrochloride as an Effective Treatment for ADHD Early Phase 1
Completed NCT01673594 - Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist Phase 4
Completed NCT02300597 - Internet-based Support for Young People With ADHD and Autism - a Controlled Study N/A
Active, not recruiting NCT01137318 - Combined Cognitive Remediation and Behavioral Intervention for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD) Phase 2
Completed NCT01404273 - Functional MRI of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder N/A
Completed NCT00573859 - The Reinforcing Mechanisms of Smoking in Adult ADHD Phase 1/Phase 2
Completed NCT00586157 - Study of Medication Patch to Treat Children Ages 6-12 With ADHD Phase 4