Impact of Equine-Assisted Therapy on the Quality of Life of Children with Autism Spectrum Disorders (ASD)

NCT ID: NCT06698068

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-12
• Study Completion Date: 2025-11-30

Brief Summary

The main objective of this research is to measure the influence of equine-assisted therapy sessions on the quality of life of children with ASD, using the PedsQL™ 4.0 questionnaire as an evaluation tool.

The secondary objectives of this study are to measure the influence of these equine therapy sessions on the quality of life of parents of children with ASD, using the PAR-DD-QOL questionnaire, and to qualitatively analyze the progress of children in terms of communication, motor skills, social connections, etc., during equine therapy sessions, through tracking sheets.

This interventional, prospective, and monocentric study aims to evaluate the effect of equine therapy on the quality of life of children with ASD and their families. As a pilot study, it aims to assess the feasibility of a larger-scale study with a rigorous methodology, with the aim of including a control group and conducting a randomized, multicentric, single-blind trial in future studies. It will take place at the La Musse Hospital - La Renaissance Sanitaire, specifically within the equine therapy center of the La Musse facilities. Recruiting 20 children (8-12 years old) with ASD is required for this study. To do this, the inclusion criteria are as follows: participants must be children aged 8 to 12, diagnosed with ASD by a doctor. They must be able to participate in equine-assisted therapy sessions and understand instructions during these sessions. In addition, they must be affiliated with the social security system. The primary and secondary assessment criteria respectively include the average of the two scores obtained from the PedsQL™ 4.0 child and parent report questionnaires; the overall score of the PAR-DD-QOL questionnaire, as well as the qualitative analysis of the equine therapists' tracking sheets. Measures are taken to minimize selection, recruitment, and confusion biases, and specific eligibility criteria are defined. Each participant will benefit from 15 equine therapy sessions, twice a week, over 7 to 8 weeks. Each session will last 60 minutes.

The intervention of this study begins with the participant selection process, including an initial contact by phone or during a medical consultation, followed by an oral explanation and the provision of written information to parents and the child. After a reflection period, and if they agree, the parents and the child sign a consent form. The children then undergo 15 equine therapy sessions, including various activities such as emotional expression, contact with the horse, grooming, activities on foot or on horseback, and a debriefing time. Quality-of-life evaluations will be conducted five times during the study using the PedsQL™ 4.0 child, PedsQL™ 4.0 parent report, and PAR-DD-QOL questionnaires (before the first session, after the first session, at the 5th session, at the 10th session, and at the 15th session). Additionally, a tracking sheet will be completed by equine therapists during the sessions. The criteria for interrupting or modifying interventions are established, allowing participants to withdraw at any time for various reasons. Strategies are implemented to improve adherence to rehabilitation protocols, such as regular reminders and the distribution of a schedule of appointments. The individuals concerned are fully informed of the study and their rights.

The expected outcomes include an improvement in the average quality-of-life scores of children with ASD, an improvement in the quality-of-life score of their parents, and behavioral progress in the children. The sample size is set at 20 children with ASD, with a detailed statistical analysis plan using Excel and SPSS.

Conditions

Equine-assisted Therapy; Children; Autism Spectrum Disorder; Quality of Lifte

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

15 equine therapy sessions

Group Type: EXPERIMENTAL

Equine-assisted therapy

Intervention Type: OTHER

15 equine therapy sessions, twice a week, over 7 to 8 weeks. Each session will last 60 minutes, including various activities such as emotional expression, contact with the horse, grooming, activities on foot or on horseback, and a debriefing time.

Interventions

Equine-assisted therapy

15 equine therapy sessions, twice a week, over 7 to 8 weeks. Each session will last 60 minutes, including various activities such as emotional expression, contact with the horse, grooming, activities on foot or on horseback, and a debriefing time.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Children aged between 8 and 12 years.
• Diagnosed with ASD by a doctor.
• Able to participate in equine therapy sessions.
• Capable of understanding instructions during equine therapy sessions.
• Affiliated with the social security system.

Exclusion Criteria

• Children with ASD associated with ADHD (Attention Deficit Hyperactivity Disorder) and/or ODD (Oppositional Defiant Disorder) and/or ID (Intellectual Developmental Disorder) and/or DLD (Developmental Language Disorder) with comprehension impairments.
• Ongoing equine-assisted therapy interventions.
• Other severe medical conditions that may impair participation in sessions.
• Allergies to horses.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Paul Bennetot

OTHER

Sponsor Role: collaborator

Hopital La Musse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital La Musse

Saint-Sébastien-de-Morsent, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Héloïse BAILLET, PhD

Role: CONTACT

h.baillet@hlrs-lamusse.net

+33(0)232293047

Julie LE BALC'H

Role: CONTACT

j.lebalch@hlrs-lamusse.net

+33(0)232293001

Facility Contacts

Julie LE BALC'H

Role: primary

j.lebalch@hlrs-lamusse.net

+33(0)232293031

Héloïse BAILLET, PhD

Role: backup

Frédérique BENEZ, Dr - MSc

Role: backup

Elodie GEHER-JOLY, Dr

Role: backup

Charlotte MENEZ, PhD

Role: backup

Eléna DEFROMERIE, MSc - CCC - SLT

Role: backup

Thibaut LEMOINE, MSc

Role: backup

Other Identifiers

2024-A00256-41

Identifier Type: -

Identifier Source: org_study_id