Tel Aviv University
Tel Aviv, Israel, 69978
NCT Number: NCT05869253
The goal of this clinical trial is to develop and validate an Equine Assisted Occupational Therapy Intervention for children aged 6-12 with Attention Deficit Hyperactivity Disorder.
The research aims to study the effect of an EAOT intervention on cognitive-emotional aspects, daily function and participation among these children using various measurements including physiological measures (EEG, heart rate for rider and horse), questionnaires and different tasks. It aims to enable the creation of an evidence based protocol for professionals in order to provide a better suited therapy for children with ADHD and enable them to live a full life. Participants will enroll in a 12 week EAOT intervention including one session per week of 45 minutes with a waiting period prior the intervention. Participants will go through assessments prior waiting time, prior the intervention and post intervention.
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Notify Me6 year–12 year
All sexes
Interventional
Not applicable
Tel Aviv, Israel, 69978
Introduction: Attention deficit/hyperactivity disorder (ADHD), characterized by inattention, hyperactivity and impulsivity, is currently one of the most common diagnoses given to children. ADHD is characterized by a developmental and chronic impairment, Executive Functions (EFs), cognitive-emotional and sensory-motor functions, as well as a wide variety of difficulties in daily tasks beyond the core symptoms. Literature review indicated that current intervention protocols include pharmacological treatment and address specific aspects such as behavioral or psychological, though scarce interventions address both.
Objectives: The purpose of this study is to examine the feasibility of conducting an Equine Assisted Occupational Therapy (EAOT) intervention for children with ADHD aiming to improve EFs, cognitive-emotional functions and participation.
Method: A prospective cohort study with Interrupted Time-Series design will be conducted. Forty participants and their parents who were referred to EAOT will be recruited from the waiting list of Harey Yehuda stables. Assessments will take place at four time points. Time 1: baseline-when referred for EAOT. Time 2: pre-test, before first treatment session, end of 12 week waiting period. Time 3: post-test after 12 weeks of intervention and time 4: post intervention assessment, three months follow up. The intervention will be administered by a licensed EAOT, and assessments will be done by a blinded licensed occupational therapist (OT). Standardized assessment measures will be used to measure EFs, cognitive-emotional and sensory-motor aspects as well as participation at each time point.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
: A prospective cohort study with Interrupted Time-Series design will be conducted. Forty participants and their parents who were referred to EAOT will be recruited from the waiting list of Harey Yehuda stables. Assessments will take place at four time points. Time 1: baseline-when referred for EAOT. Time 2: pre-test, before first treatment session, end of 12 week waiting period. Time 3: post-test after 12 weeks of intervention and time 4: post intervention assessment, three months follow up. The intervention will be administered by a licensed EAOT, and assessments will be done by a blinded licensed occupational therapist (OT). Standardized assessment measures will be used to measure EFs, cognitive-emotional and sensory-motor aspects as well as participation at each time point.
Other names: Taking the Reins
Time frame: 3 months
standardized ecological rating scale filled by a parent, designed to reflect the neuropsychological constructs of EF in everyday situations for children aged 5-18
Time frame: 3 months
The TOH test measures EF with non-verbal content and requires spatial perception of position. It requires a generation of a multistep sequence of move and strategy selection. It requires executing the sequence of moves while inhibiting the incorrect moves
Time frame: 3 months
a real-time electrophysiological marker for sustained attention extracted from a simple and easy-to-use one-channel NeuroSky EEG MindWave system
Time frame: 3 months
a 11-item questionnaire designed to measure a general set of expectations that the individual carries into new situations and his perception regarding his abilities to achieve goals in various situations and overcome challenges
Time frame: 3 months
is a self-reported 41 questions scale for children and parents, designed to screen DSM-5 anxiety disorders
Time frame: 3 months
consists of 6 statements to which students respond on a 6-point Likert-type scale ranging from 1 (none of the time) to 6 (all of the time). There are three agency items (e.g., "I think I am doing pretty well") and three pathways items (e.g., "I can think of many ways to get things in life").
Time frame: 3 months
a standardized, norm-referenced measure used by physical therapists and occupational therapists in clinic and school practice settings. It is an individually administered measure of fine and gross motor skills of children and youth, 4 through 21 years of age and is used by practitioners and researchers as a discriminative and evaluative measure to characterize motor performance, specifically in the areas of fine manual control, manual coordination, body coordination, and strength and agility.
Time frame: 3 months
The Short sensory profile (SSP; Dunn, 1999) is a 38- item questionnaire that assesses seven sensory domains: tactile, taste; smell; movement; under-responsive/seeks sensation; auditory filtering; low energy/weak, and visual/auditory
Time frame: 3 months
a questionnaire designed for parents to assess 3 skill domains: motor, process, and communication a questionnaire designed for parents to assess 3 skill domains: motor, process, and communication a questionnaire designed for parents to assess 3 skill domains: motor, process, and communication a questionnaire designed for parents to assess 3 skill domains: motor, process, and communication
Time frame: 3 months
a parent-reported questionnaire measuring participation of preschool children aged 4-6 years in their everyday activities
Time frame: 3 months
a standardized client-centered tool designed for use by occupational therapists to detect self-perceived change in occupational performance problems over time in children over the age of 5
Tel Aviv University
Other
The Efficacy of Attention Skill Therapy (ASTride), an Equine Assisted Occupational Therapy Intervention, for Children With Attention Deficit Hyperactivity Disorder (ADHD) on Cognitive-emotional Aspects, Daily Function and Participation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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