Attention Deficit Hyperactivity Disorder
Conditions
Keywords
Attention Deficit Hyperactivity Disorder, Self Regulation, Karate, Occupational Therapy, Participation
Brief summary
The goal of this clinical trial is to examine the effectiveness of Adaptive Karate Training (AKT) in improving self-regulation and daily function in children with ADHD, exploring the underlying mechanisms. The main questions it aims to answer are: 1. Is the AKT more effective than no karate training in enhancing functional performance, self-regulation and school QoL? 2. Are poorer executive functions, emotional regulation, and sensory processing associated with higher gains? Researchers will compare two sequences: (1) A group receiving AKT followed by a no-intervention period; (2) A group receiving no intervention, followed by the AKT intervention, to see if differences are observed between intervention and no-intervention periods, both between groups and within participants over time. Participants will engage in AKT sessions twice a week, each session lasting 60 minutes, over a period of two months.
Detailed description
Methods: Following baseline assessment (T1), participants will be randomly allocated to one of the two sequences. After an eight-week period, all participants will complete a second assessment (T2). The groups will then switch conditions: children who initially received the AKT will receive no intervention, while those in the control group will receive the AKT. A third assessment (T3) will be conducted for all participants eight weeks post T2. All assessments will be administered by an assessor blinded to group allocation. Participants: Sample size calculation was performed with G\*Power 3.1.9.7 to detect between group differences (F test, ANOVA: Repeated measures, within-between interaction) with a medium effect size (f=0.2), significance level=0.05 and power=0.8. The total sample size needed is 50, and considering \ 10% dropout, a total of 55 children, ages 6-12 will be recruited. Intervention: Adapted Karate Training (AKT) is a structured, group-based intervention derived from traditional karate practice and modified to accommodate the attentional, sensory, emotional, and self-regulatory characteristics of children with ADHD. The protocol emphasizes continuity of participation, positive experiences, and the development of individualized self-regulation strategies through adapted movement sequences, structured routines, and supportive instructional method. All participants in the study will engage in AKT sessions twice weekly, each session lasting 60 minutes, over a period of two months. Data Analysis: Descriptive statistics will be used to describe the participants in terms of their demographic information, primary and secondary outcome measures. Data will be analyzed using repeated-measures models appropriate for a randomized controlled crossover design, examining within-subject changes over time and between-condition effects, while accounting for intervention order. Effect sizes will be reported. Statistical significance will be set at p \< 0.05.
Interventions
OTHERAdapted karate training
Participants will undergo adapted karate training practices, 2 hours weekly for two months, with a karate instructor and an Occupational Therapist specializing in neurodevelopmental disorders, including ADHD.
Sponsors
Tel Aviv University
Assuta Ashdod Hospital
Ministry of Health, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
assessors in the RCT will be blind to group allocation.
Intervention model description
Randomized controlled crossover trial including two sequences: (1) The experimental group receiving AKT followed by a no-intervention period; (2) A control group receiving no intervention, followed by the AKT intervention.
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed by a developmental neurologist with ADHD * Age 6-12 years * Fluent in Hebrew
Exclusion criteria
* Comorbidity with another psychiatric or neurological diagnosis, or a developmental syndrome * Chronic pain * enrolled in a special education system * substance abuse (i.e., reporting more than 10 cups of alcohol a week) * currently participating in other non-pharmaceutical therapies (e.g., cognitive therapies) started during the past 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Canadian Occupational Performance Measure (COPM) | changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2). | The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure for individuals to identify and prioritize everyday issues that restrict their participation in everyday living. Participants will define three goals, and rate their current performance \& satisfaction for each goal using a 10-point scale. Higher scores indicate better outcomes. |
| Total number of participants completing the intervention | completing 15 sessions over eight weeks. | Total number of participants completing the AKT, 15 sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dual Tasking gait analysis | changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2). | gait analysis (stride and pace) of a one minute walk: first walking only, then walking while doing a cognitive task (following digits via audio and recognizing repeated items). |
| Behavioral Assessment of the Dysexecutive Syndrome for Children (BADS-zoo map) | Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2). | A standardized assessment battery that examines executive function in children and adolescents aged 8-16 years. The BADS-C consists of six subtests (adapted and simplified from the BADS) that assess inflexibility, perseverance, novel problem solving, impulsivity, planning, and the ability to utilize feedback in order to moderate behavior. We will use the Zoo map subtest. Raw scores for each of the component subtests can be converted to age-scaled scores, which are adjusted for the child's age and estimated IQ. Age-scaled scores range from 1 to 19, with a mean of 10 and a standard deviation of 3. |
| The Birthday Task Assessment | Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2). | The Birthday Task Assessment is a performance-based tool assessing executive functions in children aged 8-16, through a simulated daily activity. It includes three progressively complex tasks: wrapping gifts, writing a card, and making sandwiches. Performance is evaluated by sequencing, timing, and rule adherence, with higher error rates indicating greater executive difficulties. |
| The The Preschool Executive Task Assessment (PETA) | Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2). | The The Preschool Executive Task Assessment (PETA) is a performance-based measure assessing executive functioning in young children aged 3-8, through completion of a structured, multi-step task involving assembling a caterpillar picture. Performance is scored based on task completion time and a standardized hierarchy of cues ranging from independent performance to full physical assistance, with higher scores indicating greater reliance on external. |
| Behavior Rating Inventory of Executive function (BRIEF) | Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2). | An 86-item questionnaire assessing executive function in everyday environments. The BRIEF is composed of eight clinical scales, which together produce an overall Global Executive Composite (GEC). Based on the past 30 days, items are graded on a 3-point scale: 'never' (1), 'sometimes' (2), or 'always' (3). The raw scores are converted to T-scores which are used to interpret the child's level of executive functioning as reported by parents and/or teachers on the BRIEF rating forms. These scores are linear transformations of the raw scale scores (M = 50, SD = 10). |
| Short Sensory Profile (SSP 2) | Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2). | A 34-item parent screening questionnaire designed to measure behaviors associated with abnormal responses to sensory stimuli in children aged 3.0-14.11 years. Response scale aimed at the frequency the child displays each scenario (item), and scored on a Likert scale ranging from 1 (almost never = 10% or less) to 5 (almost always = 90% or more). Scores are compiled into a "sensory-processing" domain that directly links with sensory modulation (14 item scale); and a "sensory-behavior" domain that links to behavioral concerns reflective of sensory modulation difficulties (20 item scales). For the sensory processing scale, 32-40 indicates "more than others", 41-70 indicates "much more than others". For behavioral scale, 47-59 indicates "more than others", 60-100 indicates "much more than others". |
| Difficulties in Emotion Regulation Scale- Parent Report (DERS-P) | Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2). | The DERS-P is a 36-item parent report, aimed to assess parental perceptions of adolescent Emotional Dysregulation, measuring six facets of emotion regulation: Awareness (6 items), Clarity (5 items), Goals (5 items), Impulse (6 items), Nonacceptance (6 items), and Strategies (8 items). Items are rated on a scale of 1 ("almost never" 0-10%) to 5 ("almost always" 91-100%). Higher scores indicate greater ED. |
| Participation In Childhood Occupation (PICO) | Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2). | A 30-item instrument which measures the difficulty level, enjoyment, and frequency of performance for children's participation in daily occupations in a variety of environments throughout the day. The parent assesses each activity in all three parameters, with answers ranging from 1 (no difficulty) to 5 (much difficulty). |
| Quality of life in school (QoLS) questionnaire | Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2). | A 36 item questionnaire for elementary school students, which includes statements regarding situations and experiences of a student throughout the school day. The child rates these sentences as true to his experience or not, on a scale of 1-4 (1- never true, 4- always true). |
| Participation in Physical Activity and Sedentary Behavior Questionnaire (PQ) | Changes in scores between pre (T1-week 0) to T2 (8 weeks later), to T3 (8 weeks post T2). | The PQ is a parent questionnaire that assesses the extent of a child's engagement in PAs and in sedentary recreational activities. The PQ-Modified, used in this study, includes two of the 12 items from the PQ: (a) the average number of weekly hours that the child engages in various PAs (structured as well as unstructured activities) and (b) the child's PA level compared to his or her peers, rated on a Likert scale (1 ¼ very inactive, 5 ¼ very active). |
| In-depth semi-structured interview | T3 (8 weeks post T2(8 weeks from baseline)). | A semi-structured interview, comprising of 2 open-end questions aiming to understand how parents of children with ADHD perceive the contribution of the intervention process to their child. The interview will comprise questions such as What did the intervention program contribute to your child? |
Countries
Israel
Contacts
CONTACTTami Bar-Shalita, Dr.
CONTACTYehudit Harris, MSc
STUDY_DIRECTORTami Bar-Shalita, Proffesor
Tel Aviv University
STUDY_DIRECTORItai Berger, Professor
Assuta Ashdod Hospital
Outcome results
None listed