NCT04375059

Brief Summary

Using a double-blind, randomized controlled design to investigate the therapeutic effects of interactive attention training for children with Attention Deficit Hyperactivity Disorder who are receiving conventional rehabilitation programs due to developmental delay.

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 May 2020

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

April 29, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

April 29, 2020

Last Update Submit

May 4, 2020

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

attention trainingchildrentherapeutic effectsdevelopmental delay

Outcome Measures

Primary Outcomes (1)

  • changes of symptoms of attention deficit hyperactivity disorder

    score assessed by Swanson, Nolan and Pelham questionnaire

    score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a better outcome

Secondary Outcomes (12)

  • changes of sensory integration

    score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome

  • changes of visual motor integration

    score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome

  • changes of intelligence

    score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome

  • changes of functional performance

    score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome

  • changes of health-related quality of life

    score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome

  • +7 more secondary outcomes

Study Arms (2)

Study group

ACTIVE COMPARATOR

3 months of interactive attention training programs, 2 times per week, 15 min per session, a total of 24 sessions, with conventional rehabilitation programs

Other: using interactive attention training system

Control group

NO INTERVENTION

3 months of conventional rehabilitation programs without interactive attention training programs

Interventions

using interactive attention training systemOTHER

using the interactive attention training system to children with Attention Deficit Hyperactivity Disorder

Study group

Eligibility Criteria

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

You may qualify if:

  • children with a diagnosis of Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient 70 or greater

You may not qualify if:

  • age less than 4 or greater than 8 of children diagnosed with Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional 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 Ru-Lan, MD

    Shin Kong Wu Ho-Su Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ru-Lan Hsieh, MD

CONTACT

886228332211M001052@ms.skh.org.tw

Ru-Lan Ru-Lan, MD

CONTACT

886228332211M001052@ms.skh.org.tw

Study Design

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

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 5, 2020

Study Start

May 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

May 5, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)