RCT of EF Family Training for P ADHD

Shanghai Jiao Tong University

Status: Enrolling

Conditions: ADHD

Treatments: Behavioral: treat as usual; Behavioral: executive function family training

Study type: Interventional

Funder types: Other

Identifiers

NCT04454008

XH-20-012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 48 to 71 months old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Intervention

Experimental group

Description:

The intervention group will receive 12 sessions of executive function family training, including executive function training for children and parenting guidance for parents.

Treatment:

Behavioral: executive function family training

waiting

Active Comparator group

Description:

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

Treatment:

Behavioral: treat as usual