Attention Deficit and Disruptive Behavior DisordersNCT03976570
The Effect of Occupational Therapy on Subthreshold Attention Deficit Hyperactivity Disorder
A study testing Occupational Therapy in people with Attention Deficit and Disruptive Behavior Disorders, run by Erzurum Regional Training & Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the effectiveness of occupational therapy in subthreshold attention deficit hyperactivity disorder. Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Attention Deficit and Disruptive Behavior Disorders
- What is being tested?
- Occupational Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jan 2018to 17 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subthreshold Attention Deficit Hyperactivity Disorder
Who cannot join
- Attention Deficit Hyperactivity Disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzurum Regional Training and Research Hospital
Erzurum
About this study
The purpose of this study is to investigate the effectiveness of occupational therapy in subthreshold attention deficit hyperactivity disorder.
Read the 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.
- Being tested
- Occupational Therapy
- Medical subject headings
- Attention Deficit and Disruptive Behavior Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational TherapyBehavioural
Occupational therapy to children with subthreshold attention deficit hyperactivity disorder
| Study group | Role | What they receive |
|---|---|---|
| Occupational Therapy | Experimental | Occupational Therapy Receives: Behavioral: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (4)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start17 Jan 2018
- Primary completion17 Jul 2018
- Study completion17 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit and Disruptive Behavior DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzurum Regional Training & Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hicran Doğru, Erzurum Regional Training & Research Hospital
- Investigators
- Hicran Doğru, Principal investigator, Erzurum Regional and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976570
- Sponsor's protocol ID
- 0001
- Status last verified
- Jun 2019
- First submitted
- 4 Jun 2019
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Occupational Therapy on Subthreshold Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT03976570
- Acronym / sponsor ID
- 0001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Erzurum Regional Training & Research HospitalOther government
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 17 Jul 2018 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Occupational Therapy | Experimental | Behavioral: Occupational TherapyOccupational Therapy |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Subthreshold Attention Deficit Hyperactivity Disorder
Key exclusion criteria (1 listed)
- Attention Deficit Hyperactivity Disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational TherapyOccupational therapy to children with subthreshold attention deficit hyperactivity disorder | Behavioural | Occupational Therapy |
Primary outcome
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.
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.
4 secondary outcomes
The Conner's parent rating scale
Time frame: 12 weeks
Conners' Teacher Rating Scale
Time frame: 12 weeks
Canadian Occupational Performance Measure
Time frame: 12 weeks
Clinical Global Impressions (CGI) Scale:
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hicran Doğru principal investigator
Erzurum Regional and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy in people with Attention Deficit and Disruptive Behavior Disorders, run by Erzurum Regional Training & Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dunn Sensory Profile (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.