RCT of EF Family Training for P ADHD

ADHD Clinical Trial

Official title:

Executive Functioning Family Training for Preschool Children With Attention Deficit Hyperactivity Disorder - a Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04454008
• Other study ID #: XH-20-012
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2020
• Est. completion date: October 30, 2025

Study information

• Verified date: May 2020
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Jinsong Zhang, Doctor
• Phone: 008613651601596
• Email: zhangjinsong[@]xinhuamed.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To explore the effect of executive function family training for preschool children with ADHD, providing early social psychological intervention for aiming the core impairments of ADHD.

Description:

100 preschool children with ADHD will be randomly divided into the intervention group and the waiting group. The waiting group received regular clinical intervention, while the intervention group received 12-week training. The intervention program includes executive function training for ADHD children and parenting guidance for parents by two therapists respectively, which were carried out in two meeting rooms in Xinhua Hospital. Therapists are psychiatrists with a background in child psychiatry and psychotherapists with training in ADHD area. After 12 weeks, the improvement of ADHD core symptoms and executive function was compared.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 48 Months to 71 Months

Eligibility

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).

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• executive function family training
Intervention programs include executive function training for children with ADHD and parenting guidance for parents
• treat as usual
Outpatient routine health education, behavioral guidance and family support

Locations

Country	Name	City	State
China	Xinhua Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD core symptoms	ADHD core symptoms are assessed by Swanson, Nolan, and Pelham Rating Scale (SNAP), with the score ranged from 0-54 (the higher the socre, the worse the symptoms)	12 weeks after baseline
Secondary	Executive function-Inhibition	The executive function inhibition is assessed by NEPSY-II task Status (ST) with the higher the score is, the better the function.	12 weeks after baseline
Secondary	Executive function-working memory	The executive function working memory is assessed by NEPSY-II task memory design (MD) with the higher the score is, the better the function.	12 weeks after baseline