- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05384808
Canine-assisted Psychotherapy Motivation Alliance (CAP)
May 3, 2023 updated by: Dr. Karin Hediger, University of Basel
Effects of the Inclusion of a Dog in Psychotherapy on Children's Alliance and Treatment Motivation
The aim of the study is to investigate the needed extent and the way a dog is integrated into psychotherapeutic interventions for them to be motivating and alliance building for children and adolescents with psychiatric disorders aged 9 to 17 years old.
Specifically, we want to elaborate if the dog needs to be integrated into the therapy in a form that it is part of the therapeutic context or if the presence of the dog without being part of the therapeutic context per se is beneficial.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Karin Hediger, Prof. Dr.
- Phone Number: (+41) 061 207 65 80
- Email: karin.hediger@unibas.ch
Study Contact Backup
- Name: Wanda Arnskötter, Msc.
- Email: wanda.arnskoetter@unibas.ch
Study Locations
-
-
-
Basel, Switzerland
- Recruiting
- University of Basel
-
Contact:
- Karin Hediger, Prof. Dr.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age between 9 and 17 years
- Children are seeing the therapist for the first time
- Basic knowledge of child and parents in either German or English to be able to fill in questionnaires
- Informed consent given by legal guardian
- Positive or neutral attitude towards dogs
Exclusion Criteria:
- acute psychosis; early childhood autism
- fear of dogs
- allergic reactions to dogs
- reported aggressive behavior towards animals in the past
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: No dog present
Conventional psychotherapy with no dog being present.
|
Participants receive a standard psychotherapy session with no dog being present.
|
Experimental: Dog present and active part of therapeutic narrative.
The dog is actively integrated into the therapeutic narrative.
|
A dog is present and actively integrated into the therapeutic narrative.
|
Experimental: Dog present but not active part of therapeutic narrative.
The dog is present but not actively integrated into the therapeutic narrative.
|
A dog is present but not actively integrated into the therapeutic narrative.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Therapeutic alliance of patients
Time Frame: 9 weeks
|
Patient's reported therapeutic alliance is measured after the first, the third and the fifth therapy session of a newly began psychotherapy using the german adaptation of the "Therapeutic Alliance Scales for Children" (TASC)".
The TASC consists of 12 items, answered with a 4 point likert scale.
The questionnaire assesses the therapeutic alliance from the perception of the child.
Four weeks after the fifth therapy session children will be asked to fill in the questionnaire again as follow-up measurement.
|
9 weeks
|
Motivation of patients
Time Frame: 9 weeks
|
Patient's reported motivation is measured after the first, the third and the fifth therapy session of a newly began psychotherapy using the "Situational Motivation Scale for children (SMS-15)".
The SMS-15 consists of 15 items answered with a 7 point likert scale.
Four weeks after the fifth therapy session, children will be asked to fill in the questionnaire again as follow-up measurement.
|
9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment satisfaction of patients
Time Frame: 4 weeks
|
Treatment satisfaction of children is measured after the fifth therapy session as well as four weeks after as follow up using the "treatment assessment questionnaire (FBB)".
The FBB consists of 20 items answered with a 5 point likert scale.
|
4 weeks
|
Number of missed sessions
Time Frame: 5 weeks
|
Number of missed sessions and drop-outs will be documented for each child participating in the study.
|
5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2022
Primary Completion (Anticipated)
December 31, 2024
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
May 2, 2022
First Submitted That Met QC Criteria
May 18, 2022
First Posted (Actual)
May 20, 2022
Study Record Updates
Last Update Posted (Estimate)
May 4, 2023
Last Update Submitted That Met QC Criteria
May 3, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2022-00304
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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