NCT02656758

Brief Summary

The investigators intent to recruit 80 attention deficit hyperactivity disorder families. The attention deficit hyperactivity disorder families had received executive function training one year before.They will be randomized to intervention group and control group using a block randomization design. The intervention group will participate in intensive executive function training immediately,while the control group will receive executive training after 3 months.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

1.9 years

First QC Date

January 11, 2016

Last Update Submit

October 9, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in attention deficit hyperactivity disorder-rating scale

    baseline, after the training (12 weeks)

Secondary Outcomes (3)

  • Change in behavior rating scale of executive function

    baseline, after the training (12 weeks)

  • Cambridge Neuropsychological Test Automatic Battery

    baseline, after the training (12 weeks)

  • Behavior Rating Inventory of Executive Function

    baseline, after the training (12week)

Study Arms (2)

Executive function training

EXPERIMENTAL

the experimental group will receive 12 sessions of intensive Executive function training weekly immediately

Behavioral: intensive Executive function training

the waitlist group

OTHER

the waitlist group will wait 12 weeks before receiving intensive executive function training for comparison.

Behavioral: intensive Executive function training

Interventions

Children diagnosis of attention deficit hyperactivity disorder are randomized to the experimental condition(Executive Function training) or waiting group experimental:participants will receive 12 sessions of intensive executive function training weekly no intervention :waiting participants will not be treated with intensive executive function training and keep waiting for 12 weeks for comparison

Executive function trainingthe waitlist group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • clinical diagnosis of child attention deficit hyperactivity disorder
  • full-scale intelligence quotient (FSIQ) ≥70
  • stable on medication for attention deficit hyperactivity disorder children at least 3 months
  • participation in the early implementation of functional training one year before

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Sixth Hospital/Institute of Mental Health

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Ying Qian

    Peking University Sixth Hospital/Institute of Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
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

January 11, 2016

First Posted

January 15, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

October 11, 2016

Record last verified: 2016-10

Locations