RCT of EF Family Training for P ADHD

NCT04454008 | Unknown DMC

• 1 other identifier: XH-20-012
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

ADHD; executive function; preschool; intervention; RCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Executive function-Inhibition

  12 weeks after baseline

• Executive function-working memory

  12 weeks after baseline

Study Arms (2)

Intervention

EXPERIMENTAL

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

waiting

ACTIVE COMPARATOR

The waiting group will receive routine clinical intervention, including health education, family support and guidance from outpatient clinic.

Behavioral: treat as usual

Interventions

executive function family training BEHAVIORAL

Intervention programs include executive function training for children with ADHD and parenting guidance for parents

Intervention

treat as usual BEHAVIORAL

Outpatient routine health education, behavioral guidance and family support

waiting

Eligibility Criteria

• Age: 48 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital

Shanghai, 200092, China

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Coal Tar

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tars; Complex Mixtures

Study Officials

• Jinsong Zhang, Doctor

  Director of department of psychology, xinhua hospital

  STUDY DIRECTOR

Central Study Contacts

Jinsong Zhang, Doctor

CONTACT

008613651601596; zhangjinsong@xinhuamed.com.cn

Lan Shuai, Doctor

CONTACT

008615000624346; shallon@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluator was unaware of the subjects' treatment status
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2020
• First Posted: July 1, 2020
• Study Start: December 6, 2020
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2025
• Last Updated: March 22, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)