RCT of EF Family Training for P ADHD

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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ADHD

Intervention / Treatment
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* Behavioral: executive function family training
* Behavioral: treat as usual


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 48 Months
Maximum Age: 71 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, executive function, preschool, intervention, RCT