NCT03632629

Brief Summary

Using a single blind, randomized controlled design to study the additional therapeutic effects of cognitive training on traditional rehabilitation programs for children with attention deficit hyperactivity disorder and developmental delays.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

July 13, 2018

Last Update Submit

August 13, 2018

Conditions

Keywords

cognitive trainingdevelopmental delaychildrentherapeutic effect

Outcome Measures

Primary Outcomes (1)

  • change of attention

    score assessed by Swanson, Nolan and Pelham questionnaire

    scores change from baseline to 3 months of treatment, and 3 months after treatment

Secondary Outcomes (5)

  • change of visual motor integration

    scores change from baseline to 3 months of treatment, and 3 months after treatment

  • change of sensory integration

    scores change from baseline to 3 months of treatment, and 3 months after treatment

  • change of intelligence

    scores change from baseline to 3 months of treatment, and 3 months after treatment

  • change of functional performance

    changes from baseline to 3 months of treatment, and 3 months after treatment

  • change of health-related quality of life

    changes from baseline to 3 months of treatment, and 3 months after treatment

Study Arms (2)

study group

ACTIVE COMPARATOR

3 months of individualized interactive cognitive training, 2 times per week, 15 min per session, a total of 24 sessions, in addition to traditional rehabilitation programs.

Other: interactive cognitive training

control group

NO INTERVENTION

3 months of traditional rehabilitation programs, without individualized interactive cognitive training.

Interventions

Using interactive brain club system training to children with attention deficit hyperactivity disorder with developmental delay

study group

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children diagnosed with attention deficit hyperactivity disorder with developmental delay receiving regular rehabilitation programs intelligence quotient 70 or greater

You may not qualify if:

  • age less than 4 years or elder than 8 years children diagnosed with attention deficit hyperactivity disorder receiving regular rehabilitation programs intelligence quotient less than 70

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111-01, Taiwan

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityLearning Disabilities

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ru-Lan Hsieh

    Shin Kong Wu Ho-Su Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ru-Lan Hsieh, MD

CONTACT

Ru-Lan Hsieh, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 13, 2018

First Posted

August 15, 2018

Study Start

August 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

August 15, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations