RCT of EF Family Training for P ADHD

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

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.

Study Overview

• Status: Recruiting
• Conditions: ADHD
• Intervention / Treatment: Behavioral: executive function family training; Behavioral: treat as usual

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jinsong Zhang, Doctor; Phone Number: 008613651601596; Email: zhangjinsong@xinhuamed.com.cn
• Study Contact Backup: Name: Lan Shuai, Doctor; Phone Number: 008615000624346; Email: shallon@aliyun.com

Study Locations

• China
  • Shanghai, China, 200092
    • Recruiting
    • Xinhua hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention group will receive 12 sessions of executive function family training, including executive function training for children and parenting guidance for parents.	Behavioral: executive function family training; Intervention programs include executive function training for children with ADHD and parenting guidance for parents
Active Comparator: waiting; The waiting group will receive routine clinical intervention, including health education, family support and guidance from outpatient clinic.	Behavioral: treat as usual; Outpatient routine health education, behavioral guidance and family support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Study Director: Jinsong Zhang, Doctor, Director of department of psychology, xinhua hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2020
• Primary Completion (Anticipated): October 30, 2023
• Study Completion (Anticipated): October 30, 2025

Study Registration Dates

• First Submitted: June 27, 2020
• First Submitted That Met QC Criteria: June 27, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: ADHD; preschool; RCT; intervention; executive function
• Other Study ID Numbers: XH-20-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No