Clinical trial NCT05869253: The Efficacy of Equine Assisted Occupational Therapy, for Children With Attention Deficit Hyperactivity Disorder (ADHD) on Cognitive-emotional Aspects, Daily Function and Participation
Official title: The Efficacy of Equine Assisted Occupational Therapy, for Children With Attention Deficit Hyperactivity Disorder (ADHD) on Cognitive-emotional Aspects, Daily Function and Participation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention-deficit Hyperactivity Disorder
Keywords: Equine Assisted Occupational Therapy
ADHD
strategy based
Equine Assisted Services
horse therapy
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective cohort study with Interrupted Time-Series design will be conducted.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Children between 6 and 12 years of age
* Diagnosis of ADHD from a medical professional based on DSM-5 criteria with or without medication (e.g., psychostimulant medication)
* General doctors' approval and referral for participating in EAS

Exclusion Criteria:

* Moderate to severe cognitive impairment
* Neurological disorders (e.g., epilepsy)
* Children with additional developmental disorders (e.g., Autism, Cerebral Palsy)
* Children who will begin new medicine treatment or change existing treatment during intervention
* Children with severe sensory loss (e.g., blindness).

Primary outcomes:
measure: The Behavior Rating Inventory of Executive Function (BRIEF) (Gioia, Isquith, Guy, & Kenworthy, 2000)
timeFrame: 3 months
Secondary outcomes:
measure: the Tower of Hanoi test (Lezak et al., 2004).
timeFrame: 3 months
measure: The Brain Engagement Index; BEI (Shahaf et al., 2018)
timeFrame: 3 months
measure: The new General Self-efficacy Scale (NGSE)
timeFrame: 3 months
measure: The Screen for Child Anxiety Related Emotional Disorders (SCARED)
timeFrame: 3 months
measure: The Hebrew adaptation of The Children's Hope Scale (Snyder, 2002)
timeFrame: 3 months
measure: The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
timeFrame: 3 months
measure: The Short Sensory Profile (SSP)
timeFrame: 3 months
measure: The Child Performance Skill Questionnaire (PSQ)
timeFrame: 3 months
measure: The children Participation Questionnaire (CPQ)
timeFrame: 3 months
measure: Canadian Occupational Performance Measure (COPM) (Law et al., 2014)
timeFrame: 3 months
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
References: