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

NCT06698068 | Recruiting

• 1 other identifier: 2024-A00256-41
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Equine-assisted therapy; children with ASD; Quality of life

Outcome Measures

Primary Outcomes (1)

• Score obtained from the Pediatric Quality of Life Inventory™ (PedsQl™) 4.0 - Quality of life child and parent

  The average of the two scores obtained from the PedsQL™ 4.0 child and parent report questionnaires. Higher scores mean a better quality of life.

  T0 (before the first equine therapy session), T1, T5, T10 and T15 (after the first, fifth, tenth and fifteenth equine therapy sessions)

Secondary Outcomes (2)

• Score obtained from Parental-Developmental Disorders-Quality of Life (PAR-DD-QOL) questionnaire - Parent's Quality of life

  T0 (before the first equine therapy session), T1, T5, T10 and T15 (after the first, fifth, tenth and fifteenth equine therapy sessions)

• The progress of children

  8 weeks

Study Arms (1)

Experimental group

EXPERIMENTAL

15 equine therapy sessions

Other: Equine-assisted therapy

Interventions

Equine-assisted therapy 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.

Experimental group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital La Musse: lead
• Fondation Paul Bennetot: collaborator

Study Sites (1)

Hôpital La Musse

Saint-Sébastien-de-Morsent, 27180, France

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Animal Assisted Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Héloïse BAILLET, PhD

CONTACT

+33(0)232293047; h.baillet@hlrs-lamusse.net

Julie LE BALC'H

CONTACT

+33(0)232293001; j.lebalch@hlrs-lamusse.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 20, 2024
• Study Start: September 12, 2024
• Primary Completion: September 12, 2025
• Study Completion: November 30, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

FR (1)