RCT of EF Family Training for P ADHD

Not Applicable

Recruiting

• Conditions: ADHD
• Interventions: Behavioral: executive function family training; Behavioral: treat as usual

• Registration Number: NCT04454008
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-06-27
• Study First Submitted QC: 2020-06-27
• Study First Posted: 2020-07-01
• Study Start: 2020-12-06
• Last Update Submitted: 2021-03-19
• Last Update Posted: 2021-03-22
• Primary Completion: 2023-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	executive function family training	The intervention group will receive 12 sessions of executive function family training, including executive function training for children and parenting guidance for parents.
waiting	treat as usual	The waiting group will receive routine clinical intervention, including health education, family support and guidance from outpatient clinic.

Primary Outcome Measures

Name	Time	Method
ADHD core symptoms	12 weeks after baseline	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)

Secondary Outcome Measures

Name	Time	Method
Executive function-Inhibition	12 weeks after baseline	The executive function inhibition is assessed by NEPSY-II task Status (ST) with the higher the score is, the better the function.
Executive function-working memory	12 weeks after baseline	The executive function working memory is assessed by NEPSY-II task memory design (MD) with the higher the score is, the better the function.

Trial Locations

Locations (1)

Xinhua Hospital; 🇨🇳 Shanghai, China