Back to resultsBehavioral Intervention for Children With Attention Deficit Hyperactivity Disorder(ADHD)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
A randomized controlled study of Executive Function training for children with ADHD
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Executive function training, child
Eligibility Criteria
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
Sites / Locations
- Peking University Sixth Hospital/Institute of Mental HealthRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Executive function training
Arm Description
Children diagnosis of ADHD are randomized to the experimental condition(Executive Function training) or waiting group experimental:participants will receive 12 sessions of executive function training weekly no intervention :waiting participants will not be treated with executive function therapy and keep waiting for 12 weeks for comparison
Outcomes
Primary Outcome Measures
change in ADHD-rating scale
Secondary Outcome Measures
change in behavior rating scale of executive function
cambridge Neuropsychological Test Automatic Battery
Conners
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02327585
Brief Title
Behavioral Intervention for Children With Attention Deficit Hyperactivity Disorder(ADHD)
Official Title
Study on the Psychological Behavior Intervention Technology of Attention Deficit Hyperactivity Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Min Chen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Executive function training, child
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Executive function training
Arm Type
Experimental
Arm Description
Children diagnosis of ADHD are randomized to the experimental condition(Executive Function training) or waiting group experimental:participants will receive 12 sessions of executive function training weekly no intervention :waiting participants will not be treated with executive function therapy and keep waiting for 12 weeks for comparison
Intervention Type
Behavioral
Intervention Name(s)
A randomized controlled study of Executive Function training for children with ADHD
Intervention Description
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
Primary Outcome Measure Information:
Title
change in ADHD-rating scale
Time Frame
baseline,after the training (12week)
Secondary Outcome Measure Information:
Title
change in behavior rating scale of executive function
Time Frame
baseline,after the training (12week)
Title
cambridge Neuropsychological Test Automatic Battery
Time Frame
baseline,after the training (12week)
Title
Conners
Time Frame
baseline,after the training (12week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
min chen, postgraduate
Phone
18813185425
Email
453560026@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
li yang, PHD MD
Organizational Affiliation
Peking University
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Sixth Hospital/Institute of Mental Health
City
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yang, PHD
Phone
13651220707
Email
puh60346@bjmu.edu.cn
12. IPD Sharing Statement
Citations:
PubMed Identifier
28639564
Citation
Qian Y, Chen M, Shuai L, Cao QJ, Yang L, Wang YF. Effect of an Ecological Executive Skill Training Program for School-aged Children with Attention Deficit Hyperactivity Disorder: A Randomized Controlled Clinical Trial. Chin Med J (Engl). 2017 Jul 5;130(13):1513-1520. doi: 10.4103/0366-6999.208236.
Results Reference
derived
Learn more about this trial
Behavioral Intervention for Children With Attention Deficit Hyperactivity Disorder(ADHD)
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