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

NCT02327585 | Unknown Phase 1 DMC

• 1 other identifier: 2011-4024-04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Executive function training; child

Outcome Measures

Primary Outcomes (1)

• change in ADHD-rating scale

  baseline,after the training (12week)

Secondary Outcomes (3)

• change in behavior rating scale of executive function

  baseline,after the training (12week)

• cambridge Neuropsychological Test Automatic Battery

  baseline,after the training (12week)

• Conners

  baseline,after the training (12week)

Study Arms (1)

Executive function training

EXPERIMENTAL

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

Behavioral: A randomized controlled study of Executive Function training for children with ADHD

Interventions

A randomized controlled study of Executive Function training for children with ADHD BEHAVIORAL

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

Executive function training

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• clinical diagnosis of child ADHD
• full-scale intelligence quotient (FSIQ) ≥70
• stable on medication for ADHD children at least 3 months

You may not qualify if:

• individuals with major neurological disorders
• a diagnosis of schizophrenia, epilepsy, mental retardation or other brain disorders

Sponsors & Collaborators

• Min Chen: lead

Study Sites (1)

Peking University Sixth Hospital/Institute of Mental Health

Beijing, 100191, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 28639564 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• li yang, PHD MD

  Peking University

  STUDY DIRECTOR

Central Study Contacts

min chen, postgraduate

CONTACT

18813185425; 453560026@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: postgraduate

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: December 30, 2014
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: December 31, 2014

Record last verified: 2014-12

Locations

CN (1)