Clinical trial NCT05063669: Cognitive Intervention in Attention Deficit and Hyperactivity Disorder
Official title: Effects of Cognitive Occupational Therapy Interventions on Executive Functions in Children With Attention Deficit and Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Cognitive Deficit
Keywords: Attention Deficit and Hyperactivity Disorder
Executive functions
Occupational therapy
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 21
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Attention Deficit Hyperactivity Disorder is a disorder in which children show insufficient attention span, hyperactivity and impulsivity according to their developmental level. It is stated that in the absence of rehabilitation, the child's social and academic functionality gradually deteriorates, there are problems in cognitive function processes and executive dysfunctions that affect daily life. The aim of this study was to investigate the effects of cognitive occupational therapy interventions on executive functions in children with Attention Deficit and Hyperactivity Disorder. 21 children aged 9-12 years were included in the research (10 study group-11 control group). One individual and one group session was applied to the study group at Biruni University Occupational Therapy Unit as 2 times per week for 8 weeks. Both groups were evaluated at the beginning and after 8 weeks with Children's Color Trails Test, Verbal Fluency Test and Stroop Test T-Bag Form. Wilcoxon Paired Sample Test and Mann Whitney U Test were used for analysis of intervention results and comparison between groups.

Detailed description: Attention-deficit/hyperactivity disorder (ADHD) is a neuropsychiatric disorder marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or growing. In individuals with ADHD, clinical findings may vary depending on development. It is frequently observed that ADHD, which has a progressive character, continues into adulthood after childhood and adolescence.

The study was conducted in Biruni University Occupational Therapy Unit. Since the individuals participating in the study were under the age of 18, an informed consent form was signed by their parents. The research was carried out between June and December 2020. The study included children aged 9-12 years who were diagnosed with ADHD according to DSM-V criteria by a psychiatrist, did not use any medication for ADHD, or were given a fixed dose 3 months ago and did not plan to change their treatment. Children who could not participate in the study because of any medical or mental health problems and who were diagnosed with any secondary diagnosis were excluded. First of all, the sociodemographic form was applied to the participants. The form consisted of questions to determine age, gender, disease history, presence of drugs used continuously, education level of parents, and whether the participant or family member had neurological or psychiatric disorders. Stroop Test T Bag Form (ST-TBAG), The Children's Color Trails Test (CCTT) and Verbal Fluency Test (VFT) were applied to all participants before and after intervention. Occupational therapy applications were carried out 40 minutes, twice a week (one individual session and one group intervention session) and total of 8 weeks. In the sessions, activities aimed at reasoning and empathy skills, problem solving, evaluating emotional cues, evaluating events from different perspectives, providing personal control, delaying reactions, motor planning, visual perception and prolonging attention span were applied. The interventions were varied according to the personal characteristics of the individuals. In group interventions with three or four participants, group games in the form of cooperation or competition were planned to develop motor planning and cognitive strategy and it was aimed to improve children's rapid decision making and adaptation skills.

Research data were evaluated in SPSS 22.0 package program. Mean±standard deviation (X±SD) was determined for the variables determined by measurement. The Wilcoxon Paired Two-Sample Test was used to compare the first and last evaluation data of the intervention and control groups and the Mann Whitney-U test was used to compare the demographic and initial evaluation data of both groups. A significance value of p\<0.05 was accepted in all statistical analyses.

Eligibility criteria: Inclusion Criteria:

* Aged 9-12 years
* Clinical diagnosis of ADHD according to DSM-V criteria by a psychiatrist
* Not taking any medication for ADHD or taking a fixed dose 3 months ago

Exclusion Criteria:

* Any medical or mental health problems
* Any secondary diagnosis

Primary outcomes:
measure: Stroop Test T Bag Form
timeFrame: 2 weeks
measure: The Children's Color Trails Test
timeFrame: 2 weeks
measure: Verbal Fluency Test
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Biruni University
Study officials:
affiliation: Biruni University
name: Remziye Akarsu, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Biruni University
name: Başar Öztürk, PhD
role: STUDY_DIRECTOR
affiliation: Biruni University
name: Amine Karademir, Bachelor
role: STUDY_CHAIR
affiliation: Biruni University
name: Melek Görgülü, Bachelor
role: STUDY_CHAIR
affiliation: Biruni University
name: Betül Güler, Bachelor
role: STUDY_CHAIR
References: