NCT06025539

Brief Summary

The goal of this clinical trial is to learn about the effects of an animal-assisted resilience training in children who experienced stressful life events or who have a diagnosis of autism spectrum disorder. The main question it aims to answer is: • Is an animal-assisted resilience training a feasible approach to increase resilience in children with a history of stressful life events or a diagnosis of autism spectrum disorder? Participants will take part in 12 training sessions of a standardized resilience training. The training is group-based, takes place outdoors, and includes interactions with different animals. It focuses on self-esteem, self-perception, dealing with emotions, and social competence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

4.4 years

First QC Date

August 22, 2023

Last Update Submit

April 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Questionnaire on resources in childhood and adolescence

    Pre-to-post assessment changes in resilience

    18 weeks

Secondary Outcomes (5)

  • Questionnaire to assess emotion regulation in children and adolescents

    18 weeks

  • Number of attended sessions

    12 weeks

  • Feeling secure and motivation to participate as measured on a 0-10 scale

    12 weeks

  • Intervention satisfaction as assessed in semi-structured interview

    18 weeks (follow-up)

  • Strengths and Difficulties Questionnaire (SDQ)

    18 weeks

Study Arms (1)

Animal-assisted resilience training

EXPERIMENTAL

12 sessions of group-based, animal-assisted resilience training.

Behavioral: Animal-assisted resilience training

Interventions

Participants take part in 12 sessions (120 minutes each), each session focuses on a topic that is related to resilience. The intervention takes part outdoors on a farm, and includes interactions with several different animals. The training takes place in small groups, and includes exercises, observations, and discussions.

Animal-assisted resilience training

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age between 2 and 4 years (toddler group) or 8 and 12 years (children group)
  • History of at least one stressful life event experience OR diagnosis of autism spectrum disorder
  • Basic knowledge of either German or English of parents and child to follow the instructions during the training sessions and completion of interviews.

You may not qualify if:

  • \- Medical contraindications for contact with animals, such as allergies or phobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Basel

Basel, 4055, Switzerland

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

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

Study Record Dates

First Submitted

August 22, 2023

First Posted

September 6, 2023

Study Start

August 10, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Data will be shared upon request and only once study results have been published.

Locations