Skip to main content
Clinical Trials/NCT05869253
NCT05869253CompletedNot Applicable

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

Tel Aviv University1 site in 1 country50 target enrollmentStarted: February 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
The Behavior Rating Inventory of Executive Function (BRIEF) (Gioia, Isquith, Guy, & Kenworthy, 2000)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Masking Description

The intervention will be administered by a licensed EAOT, and assessments will be done by a blinded licensed occupational therapist (OT).

Eligibility Criteria

Ages
6 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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).

Arms & Interventions

children diagnosed with ADHD

Experimental

After completing an eligibility assessment, adequate participants will go through baseline assessment and 12 weeks of waiting without receiving intervention; b) pre-test, before first treatment session, end of 12 week waiting period; c) post-test after 12 weeks of intervention; d) post intervention assessment, three months follow up

Intervention: The efficacy of Equine Assisted Occupational Therapy, for children with Attention Deficit Hyperactivity Disorder (ADHD) on cognitive-emotional aspects, daily function and participation (Behavioral)

Outcomes

Primary Outcomes

The Behavior Rating Inventory of Executive Function (BRIEF) (Gioia, Isquith, Guy, & Kenworthy, 2000)

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

Secondary Outcomes

  • The new General Self-efficacy Scale (NGSE)(3 months)
  • The Screen for Child Anxiety Related Emotional Disorders (SCARED)(3 months)
  • The children Participation Questionnaire (CPQ)(3 months)
  • Canadian Occupational Performance Measure (COPM) (Law et al., 2014)(3 months)
  • The Short Sensory Profile (SSP)(3 months)
  • the Tower of Hanoi test (Lezak et al., 2004).(3 months)
  • The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)(3 months)
  • The Child Performance Skill Questionnaire (PSQ)(3 months)
  • The Brain Engagement Index; BEI (Shahaf et al., 2018)(3 months)
  • The Hebrew adaptation of The Children's Hope Scale (Snyder, 2002)(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Orit Bart PhD

Lead investigator

Tel Aviv University

Study Sites (1)

Loading locations...

Similar Trials