The Effect of Occupational Therapy on Subthreshold Attention Deficit Hyperactivity Disorder

Sponsor
Erzurum Regional Training & Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03976570
Collaborator
(none)
20
1
1
5.9
3.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Occupational Therapy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Occupational Therapy on Subthreshold Attention Deficit Hyperactivity Disorder
Actual Study Start Date :
Jan 17, 2018
Actual Primary Completion Date :
Jul 17, 2018
Actual Study Completion Date :
Jul 17, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Occupational Therapy

Occupational Therapy

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

Outcome Measures

Primary Outcome Measures

  1. Dunn Sensory Profile [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.

  2. K-SADS-PL [12 weeks]

    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

  1. The Conner's parent rating scale [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.

  2. Conners' Teacher Rating Scale [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.

  3. Canadian Occupational Performance Measure [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.

  4. Clinical Global Impressions (CGI) Scale: [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Subthreshold Attention Deficit Hyperactivity Disorder
Exclusion Criteria:
  • Attention Deficit Hyperactivity Disorder

Contacts and Locations

Locations

Site City State Country Postal Code
1 Erzurum Regional Training and Research Hospital Erzurum Turkey

Sponsors and Collaborators

  • Erzurum Regional Training & Research Hospital

Investigators

  • Principal Investigator: Hicran Doğru, Erzurum Regional and Training Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hicran Doğru, Dr., Erzurum Regional Training & Research Hospital
ClinicalTrials.gov Identifier:
NCT03976570
Other Study ID Numbers:
  • 0001
First Posted:
Jun 6, 2019
Last Update Posted:
Jun 6, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 6, 2019