- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06025539
Animal-assisted Resilience Training for Children With Stressful Life Events or Autism Spectrum Disorder (AART)
Effects of an Animal-assisted Resilience Training for Children With a History of Stressful Life Events or a Diagnosis of Autism Spectrum Disorder: A Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Basel, Switzerland, 4055
- University of Basel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Medical contraindications for contact with animals, such as allergies or phobia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Animal-assisted resilience training
12 sessions of group-based, animal-assisted resilience training.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Questionnaire on resources in childhood and adolescence
Time Frame: 18 weeks
|
Pre-to-post assessment changes in resilience
|
18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Questionnaire to assess emotion regulation in children and adolescents
Time Frame: 18 weeks
|
Pre-to-post assessment changes in emotion regulation
|
18 weeks
|
|
Feeling secure and motivation to participate as measured on a 0-10 scale
Time Frame: 12 weeks
|
Motivation and feeling secure as measured at the beginning and end of each session
|
12 weeks
|
|
Intervention satisfaction as assessed in semi-structured interview
Time Frame: 18 weeks (follow-up)
|
Satisfaction with program content and structure, as measured by qualitative interview
|
18 weeks (follow-up)
|
|
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: 18 weeks
|
Pre-to-post assessment changes in peer-relationship problems and prosocial behavior measures
|
18 weeks
|
|
Number of attended sessions
Time Frame: 12 weeks
|
Number of attended sessions over the course of the training
|
12 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Resilience training
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autism Spectrum Disorder
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...Istituto Clinico HumanitasRecruitingAutism | Autism Spectrum Disorder (ASD) | Autism DisorderItaly
-
The Children's Hospital of Zhejiang University...Not yet recruitingAutism | Autism Spectrum Disorder (ASD)China
-
Poznan University of Physical EducationCompletedAutism | Autism Spectrum Disorder (ASD)Poland
-
Greater Atlanta Integrative PediatricsRecruitingAutism Spectrum Disorder | Autism | ASD | Autism Spectrum Disorder (ASD)United States
-
Adia Med of Winter Park LLCRecruitingAutism Spectrum Disorder | Autism | ASD | Autism Spectrum Disorder (ASD)United States
-
Poznan University of Physical EducationNational Science Centre, PolandCompletedAutism Spectrum Disorder | ASD | Autism Spectrum Disorder High-Functioning | Autism SpectrumPoland
-
Blinklab LimitedRecruitingAutism Spectrum Disorder | Autism | Neurodevelopmental Conditions | Autism Spectrum Disorder (ASD)United States
-
Stanford UniversityJohn and Marcia Goldman FoundationNot yet recruitingAutism | Autism Spectrum Disorder (ASD)United States
-
National Cheng-Kung University HospitalCompletedAutism Spectrum Disorder (ASD) | Autism Spectrum Disorder High-FunctioningTaiwan
-
Stanford UniversityCalifornia Department of Developmental ServicesActive, not recruitingAutism Spectrum Disorder | Autistic Disorder | Autism | Autism Spectrum Disorders | Autistic Disorders Spectrum | Autistic Spectrum Disorder | Autistic Spectrum DisordersUnited States
Clinical Trials on Animal-assisted resilience training
-
University of California, IrvineEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedAttention Deficit Hyperactivity DisorderUnited States
-
Atlas UniversityNot yet recruitingDepression | Loneliness | Old Age; Debility | Nursing Home | Loss of Interest in Activities
-
Norwegian University of Life SciencesCompleted
-
Daniel Collado-MateoAsociación Dame La PataRecruitingWork Related Stress | Occupational GroupsSpain
-
Daniel Collado-MateoPurina España (Reg. Trademark of Nestle S.A.)Enrolling by invitationEating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/BulimiaSpain
-
Daniel Collado-MateoAsociación de Padres de Personas Con Autismo (APNA); Asociación Nuevo Horizonte and other collaboratorsEnrolling by invitationAutism Spectrum Disorder | AutismSpain
-
Washington State UniversityCompletedStress, Psychological | Stress, Physiological
-
Uskudar UniversityNot yet recruiting
-
Chang Gung Memorial HospitalUnknownSchizophrenia | Animal-assisted TherapyTaiwan
-
The University of Hong KongRecruitingAutism Spectrum Disorder (ASD)Hong Kong