ClinicalTrials.gg
CompletedNCT06698068EQUI-TSAUpdated Oct 30, 2026

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

An interventional study of Equine-assisted therapy in Equine-assisted Therapy, Children and Autism Spectrum Disorder, sponsored by Hopital La Musse. Completed at 1 site in France. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Hopital La Musse · Not applicable, Interventional, and Treatment

Updated Oct 30, 2026Now CompletedPrimary completion moved+4 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
8 Years to 12 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 110 studies in Autism Spectrum Disorder with a site in France — 51 open to participants now, 55 under way, 2 of them phase 3. Autism Spectrum Disorder · France.

Enrollment
73rd of 77
11 · median 70
Started
2024
with 8 others
No phase
58 of 110
29 open now
Registered
88th of 110
by date

Among the 110 studies in Autism Spectrum Disorder with a site in France, this one is the 73rd largest by enrollment of the 77 interventional ones, is one of 9 that started in 2024, is one of 58 with no phase, and was the 88th registered.

By phase

110 studies; the count open now beside each. This study's row is marked.

No phasethis study58 · 29 open
Observational33 · 17 open
Phase 210 · 3 open
Phase 37 · 2 open
Phase 2/32 · 0 open

By the year they started

First in 2007; this study’s year is marked. 9 started in 2024.

Size and results

Median enrollment 70 across the 77 interventional studies, 120 across the 33 observational. Of the 43 that completed or were terminated, 8 (19%) have results posted.

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02

Study 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.

03

Conditions studied

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

Keywords

  • Equine-assisted therapy
  • children with ASD
  • Quality of life
04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Experimental group

    15 equine therapy sessions

    Other: Equine-assisted therapy

Interventions

  • OtherEquine-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.

06

What researchers measure

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.

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

Secondary outcomes

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

    The overall score of the PAR-DD-QOL questionnaire. Higher scores mean a worse quality of life.

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

  2. The progress of children

    The qualitative analysis of the equine therapists' tracking sheets, in terms of communication, motor skills, social connections, etc., during equine therapy sessions

    Time frame: 8 weeks

07

Study locations

1 site
  • Hôpital La Musse
    Saint-Sébastien-de-Morsent, 27180, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2024 to primary completion in Jun 2025, 9 months.

Of 800 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 9 months is below that.

Counting every sponsor, half of 823 studies reached it within 25 months; a quarter within 12 and three quarters within 47.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 30, 2026: primary completion Sep 2025 → Jun 2025 and completion Nov 2025 → Oct 2025.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2024
First posted
Nov 20, 2024
StartActual
Sep 12, 2024
Primary completionActual
Jun 17, 2025was Sep 2025
CompletionActual
Oct 30, 2025was Nov 2025
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 30, 2026
Sites
1 site added, 1 site removed
Show site
  • Hôpital La Musse · Saint-Sébastien-de-Morsent, France
Show 1 removed
  • Hôpital La Musse · Saint Sébastien de Morsent, France
Oct 30, 2026
Primary completion
Sep 12, 2025→Jun 17, 2025 (actual)
Oct 30, 2026
Study completion
Nov 30, 2025→Oct 30, 2025 (actual)
Oct 30, 2026
Enrollment
20 (estimated)→11 (actual)
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    Recruiting→Completed
    1 site added, 1 site removed
    Show site
    • Hôpital La Musse · Saint-Sébastien-de-Morsent, France
    Show 1 removed
    • Hôpital La Musse · Saint Sébastien de Morsent, France
    Primary completion Sep 12, 2025→Jun 17, 2025 (now actual)
    Study completion Nov 30, 2025→Oct 30, 2025 (now actual)
    Enrollment 20 (estimated)→11 (actual)
    + 5 other changes: identifiers, verification date, oversight details, contact details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06698068
Lead sponsor
Hopital La Musse
Collaborators
Fondation Paul Bennetot
Responsible party
Sponsor
First posted
Nov 20, 2024
Start date
Sep 12, 2024
Primary completion
Jun 17, 2025
Completion
Oct 30, 2025
Last update
Oct 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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