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Animal-assisted Resilience Training for Children With Stressful Life Events or Autism Spectrum Disorder (AART)

Primary Purpose

Autism Spectrum Disorder, Life Change Events

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Animal-assisted resilience training
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Autism Spectrum Disorder

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of BaselRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Animal-assisted resilience training

Arm Description

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

Outcomes

Primary Outcome Measures

Questionnaire on resources in childhood and adolescence
Pre-to-post assessment changes in resilience

Secondary Outcome Measures

Questionnaire to assess emotion regulation in children and adolescents
Pre-to-post assessment changes in emotion regulation
Number of attendend sessions
Number of attended sessions over the course of the training
Feeling secure and motivation to participate as measured on a 0-10 scale
Motivation and feeling secure as measured at the beginning and end of each session
Intervention satisfaction as assessed in semi-structured interview
Satisfaction with program content and structure, as measured by qualitative interview
Strengths and Difficulties Questionnaire (SDQ)
Pre-to-post assessment changes in peer-relationship problems and prosocial behavior measures

Full Information

First Posted
August 22, 2023
Last Updated
August 29, 2023
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT06025539
Brief Title
Animal-assisted Resilience Training for Children With Stressful Life Events or Autism Spectrum Disorder
Acronym
AART
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Life Change Events

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Animal-assisted resilience training
Arm Type
Experimental
Arm Description
12 sessions of group-based, animal-assisted resilience training.
Intervention Type
Behavioral
Intervention Name(s)
Animal-assisted resilience training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Questionnaire on resources in childhood and adolescence
Description
Pre-to-post assessment changes in resilience
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Questionnaire to assess emotion regulation in children and adolescents
Description
Pre-to-post assessment changes in emotion regulation
Time Frame
18 weeks
Title
Number of attendend sessions
Description
Number of attended sessions over the course of the training
Time Frame
12 weeks
Title
Feeling secure and motivation to participate as measured on a 0-10 scale
Description
Motivation and feeling secure as measured at the beginning and end of each session
Time Frame
12 weeks
Title
Intervention satisfaction as assessed in semi-structured interview
Description
Satisfaction with program content and structure, as measured by qualitative interview
Time Frame
18 weeks (follow-up)
Title
Strengths and Difficulties Questionnaire (SDQ)
Description
Pre-to-post assessment changes in peer-relationship problems and prosocial behavior measures
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karin Hediger, Prof. Dr.
Phone
‭+41 79 519 78 85‬
Email
karin.hediger@unibas.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Helen Koechlin, PD PhD
Email
helen.koechlin@uzh.ch
Facility Information:
Facility Name
University of Basel
City
Basel
ZIP/Postal Code
4055
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karin Hediger, Prof. Dr.
Phone
‭+41 79 519 78 85‬
Email
karin.hediger@unibas.ch
First Name & Middle Initial & Last Name & Degree
Helen Koechlin, PD PhD
Email
helen.koechlin@uzh.ch

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be shared upon request and only once study results have been published.

Learn more about this trial

Animal-assisted Resilience Training for Children With Stressful Life Events or Autism Spectrum Disorder

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