The Effect of Occupational Therapy on Subthreshold Attention Deficit Hyperactivity Disorder
Primary Purpose
Attention Deficit and Disruptive Behavior Disorders
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Occupational Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit and Disruptive Behavior Disorders
Eligibility Criteria
Inclusion Criteria:
- Subthreshold Attention Deficit Hyperactivity Disorder
Exclusion Criteria:
- Attention Deficit Hyperactivity Disorder
Sites / Locations
- Erzurum Regional Training and Research Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Occupational Therapy
Arm Description
Occupational Therapy
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
The Conner's parent rating scale
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.
Conners' Teacher Rating Scale
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.
Canadian Occupational Performance Measure
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.
Clinical Global Impressions (CGI) Scale:
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.
Full Information
NCT ID
NCT03976570
First Posted
June 4, 2019
Last Updated
June 4, 2019
Sponsor
Erzurum Regional Training & Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03976570
Brief Title
The Effect of Occupational Therapy on Subthreshold Attention Deficit Hyperactivity Disorder
Official Title
The Effect of Occupational Therapy on Subthreshold Attention Deficit Hyperactivity Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 17, 2018 (Actual)
Primary Completion Date
July 17, 2018 (Actual)
Study Completion Date
July 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erzurum Regional Training & Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate the effectiveness of occupational therapy in subthreshold attention deficit hyperactivity disorder.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit and Disruptive Behavior Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Occupational Therapy
Arm Type
Experimental
Arm Description
Occupational Therapy
Intervention Type
Behavioral
Intervention Name(s)
Occupational Therapy
Intervention Description
Occupational therapy to children with subthreshold attention deficit hyperactivity disorder
Primary Outcome Measure Information:
Title
Dunn Sensory Profile
Description
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.
Time Frame
12 weeks
Title
K-SADS-PL
Description
The K-SADS-PL is a semi-structured interview scale, which is widely used and enables evaluation in 20 different diagnostic domains.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The Conner's parent rating scale
Description
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.
Time Frame
12 weeks
Title
Conners' Teacher Rating Scale
Description
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.
Time Frame
12 weeks
Title
Canadian Occupational Performance Measure
Description
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.
Time Frame
12 weeks
Title
Clinical Global Impressions (CGI) Scale:
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subthreshold Attention Deficit Hyperactivity Disorder
Exclusion Criteria:
Attention Deficit Hyperactivity Disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hicran Doğru
Organizational Affiliation
Erzurum Regional and Training Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erzurum Regional Training and Research Hospital
City
Erzurum
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Occupational Therapy on Subthreshold Attention Deficit Hyperactivity Disorder
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