Attention-deficit Hyperactivity DisorderNCT05869253
The Efficacy of Equine Assisted Occupational Therapy for Children With Attention Deficit Hyperactivity Disorder (ADHD) on Cognitive-emotional Aspects, Daily Function and Participation
A study testing The efficacy of Equine Assisted Occupational Therapy, for children with Attention Deficit Hyperactivity Disorder (ADHD) on cognitive-emotional aspects, daily function and participation in people with Attention-deficit Hyperactivity Disorder, run by Tel Aviv University at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention-deficit Hyperactivity Disorder
- What is being tested?
- The efficacy of Equine Assisted Occupational Therapy, for children with Attention Deficit Hyperactivity Disorder (ADHD) on cognitive-emotional aspects, daily function and participation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2023to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Attention-deficit Hyperactivity Disorder
- Being tested
- The efficacy of Equine Assisted Occupational Therapy, for children with Attention Deficit Hyperactivity Disorder (ADHD) on cognitive-emotional aspects, daily function and participation
- Keywords
- Equine Assisted Occupational Therapy, ADHD, strategy based, Equine Assisted Services, horse therapy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The efficacy of Equine Assisted Occupational Therapy, for children with Attention Deficit Hyperactivity Disorder (ADHD) on cognitive-emotional aspects, daily function and participationBehavioural
Also called Taking the Reins
: 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: The efficacy of Equine Assisted Occupational Therapy, for children with Attention Deficit Hyperactivity Disorder (ADHD) on cognitive-emotional aspects, daily function and participation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (10)
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
Measured: 3 months
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
Measured: 3 months
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
Measured: 3 months
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
Measured: 3 months
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").
Measured: 3 months
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.
Measured: 3 months
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
Measured: 3 months
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
Measured: 3 months
The children Participation Questionnaire (CPQ)
a parent-reported questionnaire measuring participation of preschool children aged 4-6 years in their everyday activities
Measured: 3 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Feb 2023
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention-deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective cohort study with Interrupted Time-Series design will be conducted.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orit Bart PhD, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869253
- Sponsor's protocol ID
- 0003949-2
- Status last verified
- Sep 2025
- First submitted
- 11 May 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Helmer A, Delore E, Bart O. Horses and ADHD: the ASTride intervention for cognitive and emotional growth. Child Adolesc Psychiatry Ment Health. 2025 Nov 21;19(1):131. doi: 10.1186/s13034-025-00990-6.
PubMed 41272733
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05869253
- Acronym / sponsor ID
- 0003949-2
- Conditions
- Attention-deficit Hyperactivity Disorder
- Keywords
- Equine Assisted Occupational Therapy, ADHD, strategy based, Equine Assisted Services, horse therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective cohort study with Interrupted Time-Series design will be conducted.
| Arm | Type | Receives |
|---|---|---|
| children diagnosed with ADHD | Experimental | Behavioral: The efficacy of Equine Assisted Occupational Therapy, for children with Attention Deficit Hyperactivity Disorder (ADHD) on cognitive-emotional aspects, daily function and participationAfter 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 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The efficacy of Equine Assisted Occupational Therapy, for children with Attention Deficit Hyperactivity Disorder (ADHD) on cognitive-emotional aspects, daily function and participationAlso: Taking the Reins: 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. | Behavioural | children diagnosed with ADHD |
Primary outcome
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
10 secondary outcomes
the Tower of Hanoi test (Lezak et al., 2004).
Time frame: 3 months
The Brain Engagement Index; BEI (Shahaf et al., 2018)
Time frame: 3 months
The new General Self-efficacy Scale (NGSE)
Time frame: 3 months
The Screen for Child Anxiety Related Emotional Disorders (SCARED)
Time frame: 3 months
The Hebrew adaptation of The Children's Hope Scale (Snyder, 2002)
Time frame: 3 months
The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
Time frame: 3 months
The Short Sensory Profile (SSP)
Time frame: 3 months
The Child Performance Skill Questionnaire (PSQ)
Time frame: 3 months
The children Participation Questionnaire (CPQ)
Time frame: 3 months
Canadian Occupational Performance Measure (COPM) (Law et al., 2014)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Derived from this study: PubMed 41272733Helmer A, Delore E, Bart O. Horses and ADHD: the ASTride intervention for cognitive and emotional growth. Child Adolesc Psychiatry Ment Health. 2025 Nov 21;19(1):131. doi: 10.1186/s13034-025-00990-6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The efficacy of Equine Assisted Occupational Therapy, for children with Attention Deficit Hyperactivity Disorder (ADHD) on cognitive-emotional aspects, daily function and participation in people with Attention-deficit Hyperactivity Disorder, run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Behavior Rating Inventory of Executive Function (BRIEF) (Gioia, Isquith, Guy, & Kenworthy, 2000) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05869253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.