The Effect of Occupational Therapy on Subthreshold Attention Deficit Hyperactivity Disorder

Attention Deficit and Disruptive Behavior Disorders Clinical Trial

Official title:

The Effect of Occupational Therapy on Subthreshold Attention Deficit Hyperactivity Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03976570
• Other study ID #: 0001
• Status: Completed
• Phase: N/A
• Start date: January 17, 2018
• Est. completion date: July 17, 2018

Study information

• Verified date: June 2019
• Source: Erzurum Regional Training & Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 17, 2018
• Est. primary completion date: July 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

Inclusion Criteria:

• Subthreshold Attention Deficit Hyperactivity Disorder

Exclusion Criteria:

• Attention Deficit Hyperactivity Disorder

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Attention Deficit Disorder with Hyperactivity
• Disease
• Mental Disorders
• Problem Behavior

Intervention

Behavioral:
• Occupational Therapy
Occupational therapy to children with subthreshold attention deficit hyperactivity disorder

Locations

Country	Name	City	State
Turkey	Erzurum Regional Training and Research Hospital	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Erzurum Regional Training & Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks