NCT03976570

Brief Summary

The purpose of this study is to investigate the effectiveness of occupational therapy in subthreshold attention deficit hyperactivity disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 17, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
Last Updated

June 6, 2019

Status Verified

June 1, 2019

Enrollment Period

6 months

First QC Date

June 4, 2019

Last Update Submit

June 4, 2019

Conditions

Attention Deficit and Disruptive Behavior Disorders

Outcome Measures

Primary Outcomes (2)

  • Dunn Sensory Profile

    The Sensory Profile is a 125-item questionnaire filled out by the caregiver that describe responses to sensory events in daily life. It is a 5-point Likert scale how frequently the child uses that response to particular sensory events. This instrument evaluates the possible effects of sensory processing to a child's performance.

    12 weeks

  • K-SADS-PL

    The K-SADS-PL is a semi-structured interview scale, which is widely used and enables evaluation in 20 different diagnostic domains.

    12 weeks

Secondary Outcomes (4)

  • The Conner's parent rating scale

    12 weeks

  • Conners' Teacher Rating Scale

    12 weeks

  • Canadian Occupational Performance Measure

    12 weeks

  • Clinical Global Impressions (CGI) Scale:

    12 weeks

Study Arms (1)

Occupational Therapy

EXPERIMENTAL

Occupational Therapy

Behavioral: Occupational Therapy

Interventions

Occupational TherapyBEHAVIORAL

Occupational therapy to children with subthreshold attention deficit hyperactivity disorder

Occupational Therapy

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Subthreshold Attention Deficit Hyperactivity Disorder

You may not qualify if:

  • Attention Deficit Hyperactivity Disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzurum Regional Training and Research Hospital

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit and Disruptive Behavior Disorders

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Hicran Doğru

    Erzurum Regional and Training Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 6, 2019

Study Start

January 17, 2018

Primary Completion

July 17, 2018

Study Completion

July 17, 2018

Last Updated

June 6, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)