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The Efficacy of Equine Assisted Occupational Therapy, for Children With Attention Deficit Hyperactivity Disorder (ADHD) on Cognitive-emotional Aspects, Daily Function and Participation

Primary Purpose

Attention-deficit Hyperactivity Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
The efficacy of Equine Assisted Occupational Therapy, for children with Attention Deficit Hyperactivity Disorder (ADHD) on cognitive-emotional aspects, daily function and participation
Sponsored by
Tel Aviv University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention-deficit Hyperactivity Disorder focused on measuring Equine Assisted Occupational Therapy, ADHD, strategy based, Equine Assisted Services, horse therapy

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Tel Aviv UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

children diagnosed with ADHD

Arm Description

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

Outcomes

Primary Outcome Measures

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

the Tower of Hanoi test (Lezak et al., 2004).
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
The Brain Engagement Index; BEI (Shahaf et al., 2018)
a real-time electrophysiological marker for sustained attention extracted from a simple and easy-to-use one-channel NeuroSky EEG MindWave system
The new General Self-efficacy Scale (NGSE)
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
The Screen for Child Anxiety Related Emotional Disorders (SCARED)
is a self-reported 41 questions scale for children and parents, designed to screen DSM-5 anxiety disorders
The Hebrew adaptation of The Children's Hope Scale (Snyder, 2002)
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").
The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
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.
The Short Sensory Profile (SSP)
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
The Child Performance Skill Questionnaire (PSQ)
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
The children Participation Questionnaire (CPQ)
a parent-reported questionnaire measuring participation of preschool children aged 4-6 years in their everyday activities
Canadian Occupational Performance Measure (COPM) (Law et al., 2014)
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

Full Information

First Posted
May 11, 2023
Last Updated
May 21, 2023
Sponsor
Tel Aviv University
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1. Study Identification

Unique Protocol Identification Number
NCT05869253
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-deficit Hyperactivity Disorder
Keywords
Equine Assisted Occupational Therapy, ADHD, strategy based, Equine Assisted Services, horse therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A prospective cohort study with Interrupted Time-Series design will be conducted.
Masking
None (Open Label)
Masking Description
The intervention will be administered by a licensed EAOT, and assessments will be done by a blinded licensed occupational therapist (OT).
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
children diagnosed with ADHD
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
The efficacy of Equine Assisted Occupational Therapy, for children with Attention Deficit Hyperactivity Disorder (ADHD) on cognitive-emotional aspects, daily function and participation
Other Intervention Name(s)
Taking the Reins
Intervention Description
: 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.
Primary Outcome Measure Information:
Title
The Behavior Rating Inventory of Executive Function (BRIEF) (Gioia, Isquith, Guy, & Kenworthy, 2000)
Description
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
Secondary Outcome Measure Information:
Title
the Tower of Hanoi test (Lezak et al., 2004).
Description
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
Title
The Brain Engagement Index; BEI (Shahaf et al., 2018)
Description
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
Title
The new General Self-efficacy Scale (NGSE)
Description
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
Title
The Screen for Child Anxiety Related Emotional Disorders (SCARED)
Description
is a self-reported 41 questions scale for children and parents, designed to screen DSM-5 anxiety disorders
Time Frame
3 months
Title
The Hebrew adaptation of The Children's Hope Scale (Snyder, 2002)
Description
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
Title
The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
Description
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
Title
The Short Sensory Profile (SSP)
Description
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
Title
The Child Performance Skill Questionnaire (PSQ)
Description
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
Title
The children Participation Questionnaire (CPQ)
Description
a parent-reported questionnaire measuring participation of preschool children aged 4-6 years in their everyday activities
Time Frame
3 months
Title
Canadian Occupational Performance Measure (COPM) (Law et al., 2014)
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Orit Bart, PhD
Phone
(+ 972 3) 6409104
Email
oritbert@tauex.tau.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Helmer, MsC
Phone
(+972) 525012595
Email
henny.helmer@gmail.com
Facility Information:
Facility Name
Tel Aviv University
City
Tel Aviv
ZIP/Postal Code
69978
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Helmer, MsC
Phone
(+972) 0525012595
Email
henny.helmer@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Efficacy of Equine Assisted Occupational Therapy, for Children With Attention Deficit Hyperactivity Disorder (ADHD) on Cognitive-emotional Aspects, Daily Function and Participation

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