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Clinical Trials/NCT04454008
NCT04454008
Recruiting
N/A

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

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 site in 1 country100 target enrollmentDecember 6, 2020
ConditionsADHD

Overview

Phase
N/A
Intervention
Not specified
Conditions
ADHD
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Enrollment
100
Locations
1
Primary Endpoint
ADHD core symptoms
Status
Recruiting
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 6, 2020
End Date
October 30, 2025
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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).

Outcomes

Primary Outcomes

ADHD core symptoms

Time Frame: 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 Outcomes

  • Executive function-Inhibition(12 weeks after baseline)
  • Executive function-working memory(12 weeks after baseline)

Study Sites (1)

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