Family training program for preschool children with ADHD
Executive Functioning Family Training for Preschool Children With Attention Deficit Hyperactivity Disorder - a Randomized Controlled Study
This study tests if a special training program for families can help preschool children with ADHD improve their focus and behavior.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 48 Months to 71 Months |
| Sex | All |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04454008 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of an executive function family training program specifically designed for preschool children diagnosed with ADHD. A total of 100 participants will be randomly assigned to either an intervention group, which will receive 12 weeks of specialized training, or a waiting group that will continue with standard clinical interventions. The program includes both executive function training for the children and parenting guidance for their caregivers, delivered by trained therapists. The study aims to assess improvements in ADHD symptoms and executive function after the intervention period.
Who should consider this trial
Good fit: Ideal candidates are preschool children aged 4 months to 5 years 11 months who meet the DSM-5 criteria for ADHD and have a total IQ above 80.
Not a fit: Patients with ADHD resulting from organic neurological diseases or those with serious mental illnesses in their guardians may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the management of ADHD symptoms in preschool children and enhance their executive functioning skills.
How similar studies have performed: Previous studies have shown promising results with similar interventions targeting executive function in children with ADHD, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Meet the diagnostic criteria for preschool ADHD, based on the the DSM-5 criteria by the attending physician or above; * Age 4 months 0 to 5 years 11 months; * Total IQ is above 80 assessed by WPPSI. Exclusion Criteria: * Attention deficit disorders resulting from organic neurological diseases, extensive developmental disorders, mental retardation, childhood schizophrenia, mood disorders, epilepsy, and other organic diseases or other primary mental disorders; * parent or guardian with a serious mental illness, such as schizophrenia, mood disorder (onset), etc., and Educational level is lower than junior middle school; * Participants who failed to attend more than 80% of the intervention sessions (at least 9 sessions).
Where this trial is running
Shanghai
- Xinhua Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Jinsong Zhang, Doctor
- Email: zhangjinsong@xinhuamed.com.cn
- Phone: 008613651601596
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.