MotivationCAPNCT05384808
Canine-assisted Psychotherapy Motivation Alliance
A study testing Standard Psychotherapy, Canine-assisted psychotherapy with dog actively integrated. and Canine-assisted psychotherapy with dog passively integrated. in people with Motivation and Alliance, Therapeutic, run by University of Basel at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Motivation, Alliance, Therapeutic
- What is being tested?
- Standard Psychotherapy, Canine-assisted psychotherapy with dog actively integrated. and Canine-assisted psychotherapy with dog passively integrated.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2022to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- working with an own therapy dog
- completed therapy training or if not completed far advanced therapy training under supervision
- working with children and adolescents aged 9 to 17 years
Who cannot join
- acute psychosis; early childhood autism
- diagnosed developmental disorder or intellectual delay; if not diagnosed, exclusion when questionnaires cannot be completed due to development level
- fear of dogs
- allergic reactions to dogs
- reported aggressive behavior towards animals in the past
- not working with an own therapy dog
- no completed or far advanced therapy training
- not working with children and adolescents aged 9 to 17 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wanda Arnskötter, Msc. contact
Switzerland1 site, 1 recruiting
- Recruiting
University of Basel
Basel
Karin Hediger, Prof. Dr.
About this study
Official title: 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.
- Conditions
- Motivation, Alliance, Therapeutic
- Being tested
- Standard Psychotherapy, Canine-assisted psychotherapy with dog actively integrated., Canine-assisted psychotherapy with dog passively integrated.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard PsychotherapyBehavioural
Participants receive a standard psychotherapy session with no dog being present.
Canine-assisted psychotherapy with dog actively integrated.Behavioural
A dog is present and actively integrated into the therapeutic narrative.
Canine-assisted psychotherapy with dog passively integrated.Behavioural
A dog is present but not actively integrated into the therapeutic narrative.
| Study group | Role | What they receive |
|---|---|---|
| No dog present | Experimental | Conventional psychotherapy with no dog being present. Receives: Behavioral: Standard Psychotherapy |
| Dog present and active part of therapeutic narrative. | Experimental | The dog is actively integrated into the therapeutic narrative. Receives: Behavioral: Canine-assisted psychotherapy with dog actively integrated. |
| Dog present but not active part of therapeutic narrative. | Experimental | The dog is present but not actively integrated into the therapeutic narrative. Receives: Behavioral: Canine-assisted psychotherapy with dog passively integrated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic alliance of patients
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.
Measured: 9 weeks
Motivation of patients
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.
Measured: 9 weeks
Secondary outcomes (2)
Treatment satisfaction of patients
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.
Measured: 4 weeks
Number of missed sessions
Number of missed sessions and drop-outs will be documented for each child participating in the study.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start1 Jun 2022
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MotivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Karin Hediger, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384808
- Sponsor's protocol ID
- 2022-00304
- Acronym
- CAP
- Status last verified
- Jul 2024
- First submitted
- 2 May 2022
- Last updated
- 18 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arnskotter W, Martin S, Walitza S, Hediger K. Effects of including a dog on treatment motivation and the therapeutic alliance in child and adolescent psychotherapy: study protocol for a randomized controlled trial. Trials. 2024 Jan 5;25(1):26. doi: 10.1186/s13063-023-07854-4.
PubMed 38183121
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Inclusion of a Dog in Psychotherapy on Children's Alliance and Treatment Motivation
- ClinicalTrials.gov ID
- NCT05384808
- Acronym / sponsor ID
- CAP / 2022-00304
- Conditions
- Motivation, Alliance, Therapeutic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No dog present | Experimental | Behavioral: Standard PsychotherapyConventional psychotherapy with no dog being present. |
| Dog present and active part of therapeutic narrative. | Experimental | Behavioral: Canine-assisted psychotherapy with dog actively integrated.The dog is actively integrated into the therapeutic narrative. |
| Dog present but not active part of therapeutic narrative. | Experimental | Behavioral: Canine-assisted psychotherapy with dog passively integrated.The dog is present but not actively integrated into the therapeutic narrative. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- acute psychosis; early childhood autism
- diagnosed developmental disorder or intellectual delay; if not diagnosed, exclusion when questionnaires cannot be completed due to development level
- fear of dogs
- allergic reactions to dogs
- reported aggressive behavior towards animals in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard PsychotherapyParticipants receive a standard psychotherapy session with no dog being present. | Behavioural | No dog present |
| Canine-assisted psychotherapy with dog actively integrated.A dog is present and actively integrated into the therapeutic narrative. | Behavioural | Dog present and active part of therapeutic narrative. |
| Canine-assisted psychotherapy with dog passively integrated.A dog is present but not actively integrated into the therapeutic narrative. | Behavioural | Dog present but not active part of therapeutic narrative. |
Primary outcome
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.
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.
2 secondary outcomes
Treatment satisfaction of patients
Time frame: 4 weeks
Number of missed sessions
Time frame: 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Derived from this study: PubMed 38183121Arnskotter W, Martin S, Walitza S, Hediger K. Effects of including a dog on treatment motivation and the therapeutic alliance in child and adolescent psychotherapy: study protocol for a randomized controlled trial. Trials. 2024 Jan 5;25(1):26. doi: 10.1186/s13063-023-07854-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wanda Arnskötter, Msc. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Psychotherapy, Canine-assisted psychotherapy with dog actively integrated. and Canine-assisted psychotherapy with dog passively integrated. in people with Motivation and Alliance, Therapeutic, run by University of Basel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karin Hediger, Prof. Dr. ((+41) 61 207 69 58, karin.hediger@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic alliance of patients (time frame: 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05384808, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.