Behavioral Intervention for Children With Attention Deficit Hyperactivity Disorder(ADHD)

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Study on the Psychological Behavior Intervention Technology of Attention Deficit Hyperactivity Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02327585
• Other study ID #: 2011-4024-04
• Status: Recruiting
• Phase: Phase 1
• First received: December 12, 2014
• Last updated: December 30, 2014
• Start date: June 2013
• Est. completion date: December 2016

Study information

• Verified date: December 2014
• Source: Peking University
• Contact: min chen, postgraduate
• Phone: 18813185425
• Email: 453560026[@]qq.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

ADHD children have executive function (EF) impairments,so we randomize the children to the training or a waitlist to improve EF ,adding contingent reinforcement to ascertain whether EF deficits are amenable to the training in children with ADHD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of child ADHD

• full-scale intelligence quotient (FSIQ) =70

• stable on medication for ADHD children at least 3 months

Exclusion Criteria:

• individuals with major neurological disorders

• a diagnosis of schizophrenia, epilepsy, mental retardation or other brain disorders

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Behavioral:
• A randomized controlled study of Executive Function training for children with ADHD
Children diagnosis of ADHD are randomized to the experimental condition(Executive Function therapy) or waiting group experimental:participants will receive 12 sessions of executive function therapy weekly no intervention :waiting participants will not be treated with executive function therapy and keep waiting for 12 weeks for comparison

Locations

Country	Name	City	State
China	Peking University Sixth Hospital/Institute of Mental Health	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Min Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in ADHD-rating scale		baseline,after the training (12week)	No
Secondary	change in behavior rating scale of executive function		baseline,after the training (12week)	No
Secondary	cambridge Neuropsychological Test Automatic Battery		baseline,after the training (12week)	No
Secondary	Conners		baseline,after the training (12week)	No