- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03976570
The Effect of Occupational Therapy on Subthreshold Attention Deficit Hyperactivity Disorder
Study Overview
Status
Intervention / Treatment
Detailed Description
Subthreshold attention deficit hyperactivity disorder may occur in a subset of children who are possibly more sensitive to their environment. Therefore, it is very important to target the elimination of symptoms with appropriate preventive therapies before this disorder occurs. One of the promising preventive therapy option may be occupational therapy.
Attention deficit hyperactivity disorder can have a negative impact on occupational performance such as: activities of daily living, education, resting, sleeping, playing and social participation. Occupational therapists are able to provide interventions to improve engagement in daily activities on social skills, play, executive functioning, impulsivity, inattention, and motor coordination.
Although the guidelines about the treatment of ADHD are primarily medically and psychologically based, certain treatment components are useful for occupational therapy practice; for example, behavioural management of the child and psychoeducational programmes for families.
However, treatment recommendations for subthreshold ADHD cases or the population at risk are limited. This study investigates the effectiveness of occupational therapy in subthreshold attention deficit hyperactivity disorder.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Erzurum, Turkey
- Erzurum Regional Training and Research Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subthreshold Attention Deficit Hyperactivity Disorder
Exclusion Criteria:
- Attention Deficit Hyperactivity Disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Occupational Therapy
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Occupational therapy to children with subthreshold attention deficit hyperactivity disorder
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dunn Sensory Profile
Time Frame: 12 weeks
|
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.
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12 weeks
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K-SADS-PL
Time Frame: 12 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Conner's parent rating scale
Time Frame: 12 weeks
|
The Conner's parent rating scale-revised: short form (CPRS-R:S): This standard measure is used as a diagnostic tool of Attention Deficit Hyperactivity Disorder.
It consists of 27 items, each rated on a 4-point Likert scale (0=not true at all to 3=very much true).
It has four subscales which are oppositional, hyperactivity, cognitive problems and ADHD index.
|
12 weeks
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Conners' Teacher Rating Scale
Time Frame: 12 weeks
|
Conners' Teacher Rating Scale- revised: short form (CTRS-R:S): This is a commonly used measure of behavioral problems associated with ADHD, which originally was developed as a measure of behavioral change for pharmacological studies.
It is also 28 items (sixteen overlap with the original short-form).
The CTRS-R:S has three scales which are Oppositional, Cognitive Problems/Inattention, and Hyperactivity.
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12 weeks
|
Canadian Occupational Performance Measure
Time Frame: 12 weeks
|
The Canadian Occupational Performance measure (COPM) is an outcome measure and semi-structured interview.
It is a measure for identify goals in the areas of self-care, productivity and leisure/play that they have difficulty performing.
In this study, each child selected three to five goals, and then parents and children rated performance and satisfaction on all goals using a 10-point scale.
Changes in scores on baseline and end of therapy are determined separately.
An increase of two or more points indicates clinically significant change.
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12 weeks
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Clinical Global Impressions (CGI) Scale:
Time Frame: 12 weeks
|
The CGI scale was developed for use in clinical trials to provide a brief assessment of the clinician's view of the patient's functioning.
The CGI has two components-the CGI-Severity (CGI-S), which rates illness severity (1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill) and the CGI-Improvement(CGI-I) (1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse) which rates change from the initiation of treatment.
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12 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Hicran Doğru, Erzurum Regional and Training Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0001 (Cancer Research Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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