NCT05869253

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

May 11, 2023

Last Update Submit

September 4, 2025

Conditions

Keywords

Equine Assisted Occupational TherapyADHDstrategy basedEquine Assisted Serviceshorse therapy

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Secondary Outcomes (10)

  • the Tower of Hanoi test (Lezak et al., 2004).

    3 months

  • The Brain Engagement Index; BEI (Shahaf et al., 2018)

    3 months

  • The new General Self-efficacy Scale (NGSE)

    3 months

  • The Screen for Child Anxiety Related Emotional Disorders (SCARED)

    3 months

  • The Hebrew adaptation of The Children's Hope Scale (Snyder, 2002)

    3 months

  • +5 more secondary outcomes

Study Arms (1)

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

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

Interventions

: 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.

Also known as: Taking the Reins
children diagnosed with ADHD

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv University

Tel Aviv, Israel, 69978, Israel

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The intervention will be administered by a licensed EAOT, and assessments will be done by a blinded licensed occupational therapist (OT).
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A prospective cohort study with Interrupted Time-Series design will be conducted.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lead investigator

Study Record Dates

First Submitted

May 11, 2023

First Posted

May 22, 2023

Study Start

February 1, 2023

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

September 8, 2025

Record last verified: 2025-09

Locations