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RCT of EF Family Training for P ADHD

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04454008
Enrollment
100
Registered
2020-07-01
Start date
2020-12-06
Completion date
2025-10-30
Last updated
2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Keywords

ADHD, executive function, preschool, intervention, RCT

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.

Interventions

BEHAVIORALexecutive function family training

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

BEHAVIORALtreat as usual

Outpatient routine health education, behavioral guidance and family support

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The evaluator was unaware of the subjects' treatment status

Eligibility

Sex/Gender
ALL
Age
48 Months to 71 Months
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
ADHD core symptoms12 weeks after baselineADHD 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

MeasureTime frameDescription
Executive function-Inhibition12 weeks after baselineThe executive function inhibition is assessed by NEPSY-II task Status (ST) with the higher the score is, the better the function.
Executive function-working memory12 weeks after baselineThe executive function working memory is assessed by NEPSY-II task memory design (MD) with the higher the score is, the better the function.

Countries

China

Contacts

Primary ContactJinsong Zhang, Doctor
zhangjinsong@xinhuamed.com.cn008613651601596
Backup ContactLan Shuai, Doctor
shallon@aliyun.com008615000624346

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026