MotivationAA TF-CBTNCT05608551
Animal-assisted Trauma-focused Therapy for Children and Adolescents
A study testing Animal-assisted trauma-focused therapy and Standard trauma-focused therapy in people with Motivation and Alliance, Therapeutic, run by University of Basel at 2 sites in Switzerland.
Trial summary
The study aims to investigate how the inclusion of an animal into a trauma-focused group therapy program (TF-CBT) affects therapy motivation of children and adolescents suffering from post-traumatic stress. 80 children and adolescents aged 9 to 17 years are recruited for the study. 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?
- Animal-assisted trauma-focused therapy and Standard trauma-focused therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Oct 2022to 31 Jul 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
- experienced a traumatic event
- remembers at least one traumatic event
- Suffering from posttraumatic stress symptoms (screened via the CATS-2; cut-off ≥ 21; cut-off must be reached by either participant or caregiver)
- Basic knowledge of child and parents in German to be able to understand content of the session and to fill in questionnaires
- Informed consent (given by legal guardian for participants younger than 14 years)
- Positive or neutral attitude towards animals
Who cannot join
- Inability to complete questionnaires due to lack of language skills or cognitive impairment
- Diagnosed autism spectrum disorder; Exclusion only if interaction with others and group ability is limited due to autism
- Reported significant impairment or safety issue (e.g., active suicidal ideation, acute psychosis)
- Known abuse of substances used for emotion regulation (e.g. cannabis, alcohol, other hard drugs)
- Fear of domestic animals
- Allergic reactions to domestic animals
- Reported aggressive behavior towards animals in the past
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
University of Basel
Basel
Karin Hediger, karin.hediger@unibas.ch
- Recruiting
Psychiatrische Universitätsklinik Zürich
Zurich
Susanne Walitza, susanne.walitza@puk.zh.ch
About this study
Official title: Effects of a Psychotherapy Group Program for Children and Adolescents With Post-traumatic Stress Symptoms
The study aims to investigate how the inclusion of an animal into a trauma-focused group therapy program (TF-CBT) affects therapy motivation of children and adolescents suffering from post-traumatic stress. 80 children and adolescents aged 9 to 17 years are recruited for the study. Participants must have experienced at least one traumatic event leading to post-traumatic stress symptoms. Participants are randomly allocated to one of two groups: animal-assisted trauma-focused therapy (AA TF-CBT) or standard trauma-focused therapy (TF-CBT). Parallel to the groups the parents/guardians of the participating children and adolescents take part in three parent meetings.
The results of the study help to gain insights into how the inclusion of animals in trauma-focused psychotherapy can contribute to children and adolescents attending therapy, being more motivated in therapy, and can successfully complete therapy.
- Conditions
- Motivation, Alliance, Therapeutic
- Being tested
- Animal-assisted trauma-focused therapy, Standard trauma-focused therapy
- Keywords
- PTSD, animal-assisted therapy, trauma-focused therapy, motivation
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal-assisted trauma-focused therapyBehavioural
Animal-assisted trauma-focused therapy (AA TF-CBT) is a specific form of trauma treatment, in which one or more animals are integrated into the therapy. AA TF-CBT follows a structured, standardized therapy manual.
Standard trauma-focused therapyBehavioural
Standard trauma-focused therapy (AA TF-CBT) is a standardized trauma therapy following a structured manual.
| Study group | Role | What they receive |
|---|---|---|
| AA TF-CBT | Experimental | Participants receive a 10-week animal-assisted trauma-focused group therapy. Receives: Behavioral: Animal-assisted trauma-focused therapy |
| TF-CBT | Active comparator | Participants receive a 10-week standard trauma-focused group therapy. Receives: Behavioral: Standard trauma-focused therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Therapy Motivation of children and adolescents from baseline to four weeks after treatment.
Therapy motivation is assessed using the validated Situational Motivation Scale for Children (SMS-15, Skalski, 2019). The SMS-15 consists of 15 items answered with a 7 point likert scale. The total score equals the ratings of the 15 items on the scale. Higher scores mean a better outcome (increased motivation), lower scores mean a worse outcome (decreased motivation). The questionnaire assesses the motivation from the perception of the child.
Measured: before treatment (baseline), after 10 weeks of treatment (post-measurement), four weeks after treatment (follow-up)
Secondary outcomes (5)
Change of Therapeutic alliance of children and adolescents from baseline to four weeks after treatment.
Therapeutic alliance is assessed 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 total score equals the ratings of the 12 items on the scale. Higher scores mean a better outcome (increased alliance), lower scores mean a worse outcome (decreased alliance). The questionnaire assesses the therapeutic alliance from the perception of the child.
Measured: before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)
Change of PTSD symptoms of children and adolescents from baseline to four weeks after treatment.
PTSD symptoms are assessed using the validated Child and Adolescent Trauma Screen 2 (CATS 7-17, Version 2.0; Sachser et al., 2022). The questionnaire consists of 20 items, answered on a 4 point likert scale. The total score equals the ratings of the 20 items on the scale. Higher scores mean a worse outcome (increased PTSD symptoms), lower scores mean a better outcome (decreased PTSD symptoms). The questionnaire assesses the PTSD symptoms from the perception of the child as well as from the caregivers perception.
Measured: before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)
Change of Self-efficacy of children and adolescents from baseline to four weeks after treatment.
Self-efficacy will be assessed via the validated Questionnaire on Resources in Child-/and Adulthood (FRKJ 8-16, Lohaus, Nussbeck, 2016). The questionnaire consists of 60 items answered on a 4 point likert scale. Higher scores mean a better outcome (increased self-efficacy), lower scores mean a worse outcome (decreased self-efficacy). The questionnaire assesses self-efficacy from the perception of the child.
Measured: before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)
Change of Quality of Life of children and adolescents from baseline to four weeks after treatment.
Quality of Life is assessed using the validated Inventory for the Assessment of Quality of Life for Children and Adolescents (ILK, Mattejat \& Remschmidt, 2006). The questionnaire consists of 9 items answered on a 5 point likert scale. Lower scores mean a better outcome (increased quality of life), higher scores mean a worse outcome (decreased quality of life). The questionnaire assesses quality of life from the perception of the child.
Measured: before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)
Qualitative assessment of participants' perception of the group therapy at follow-up.
Participants perception is assessed at follow-up using a semi-structured interview.
Measured: four weeks after treatment at follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Oct 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Principal investigator, Dr. Karin Hediger, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608551
- Sponsor's protocol ID
- 2022-01327
- Acronym
- AA TF-CBT
- Status last verified
- Jul 2024
- First submitted
- 8 Sep 2022
- Last updated
- 19 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Psychotherapy Group Program for Children and Adolescents With Post-traumatic Stress Symptoms
- ClinicalTrials.gov ID
- NCT05608551
- Acronym / sponsor ID
- AA TF-CBT / 2022-01327
- Conditions
- Motivation, Alliance, Therapeutic
- Keywords
- PTSD, animal-assisted therapy, trauma-focused therapy, motivation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 8 Nov 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 study aims to investigate how the inclusion of an animal into a trauma-focused group therapy program (TF-CBT) affects therapy motivation of children and adolescents suffering from post-traumatic stress. 80 children and adolescents aged 9 to 17 years are recruited for the study. Participants must have experienced at least one traumatic event leading to post-traumatic stress symptoms. Participants are randomly allocated to one of two groups: animal-assisted trauma-focused therapy (AA TF-CBT) or standard trauma-focused therapy (TF-CBT). Parallel to the groups the parents/guardians of the participating children and adolescents take part in three parent meetings.
The results of the study help to gain insights into how the inclusion of animals in trauma-focused psychotherapy can contribute to children and adolescents attending therapy, being more motivated in therapy, and can successfully complete therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AA TF-CBT | Experimental | Behavioral: Animal-assisted trauma-focused therapyParticipants receive a 10-week animal-assisted trauma-focused group therapy. |
| TF-CBT | Active comparator | Behavioral: Standard trauma-focused therapyParticipants receive a 10-week standard trauma-focused group therapy. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age between 9 and 17 years
- experienced a traumatic event
- remembers at least one traumatic event
- Suffering from posttraumatic stress symptoms (screened via the CATS-2; cut-off ≥ 21; cut-off must be reached by either participant or caregiver)
- Basic knowledge of child and parents in German to be able to understand content of the session and to fill in questionnaires
Key exclusion criteria (7 listed)
- Inability to complete questionnaires due to lack of language skills or cognitive impairment
- Diagnosed autism spectrum disorder; Exclusion only if interaction with others and group ability is limited due to autism
- Reported significant impairment or safety issue (e.g., active suicidal ideation, acute psychosis)
- Known abuse of substances used for emotion regulation (e.g. cannabis, alcohol, other hard drugs)
- Fear of domestic animals
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 |
|---|---|---|
| Animal-assisted trauma-focused therapyAnimal-assisted trauma-focused therapy (AA TF-CBT) is a specific form of trauma treatment, in which one or more animals are integrated into the therapy. AA TF-CBT follows a structured, standardized therapy manual. | Behavioural | AA TF-CBT |
| Standard trauma-focused therapyStandard trauma-focused therapy (AA TF-CBT) is a standardized trauma therapy following a structured manual. | Behavioural | TF-CBT |
Primary outcome
Change of Therapy Motivation of children and adolescents from baseline to four weeks after treatment.
Time frame: before treatment (baseline), after 10 weeks of treatment (post-measurement), four weeks after treatment (follow-up)
Therapy motivation is assessed using the validated Situational Motivation Scale for Children (SMS-15, Skalski, 2019). The SMS-15 consists of 15 items answered with a 7 point likert scale. The total score equals the ratings of the 15 items on the scale. Higher scores mean a better outcome (increased motivation), lower scores mean a worse outcome (decreased motivation). The questionnaire assesses the motivation from the perception of the child.
5 secondary outcomes
Change of Therapeutic alliance of children and adolescents from baseline to four weeks after treatment.
Time frame: before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)
Change of PTSD symptoms of children and adolescents from baseline to four weeks after treatment.
Time frame: before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)
Change of Self-efficacy of children and adolescents from baseline to four weeks after treatment.
Time frame: before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)
Change of Quality of Life of children and adolescents from baseline to four weeks after treatment.
Time frame: before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)
Qualitative assessment of participants' perception of the group therapy at follow-up.
Time frame: four weeks after treatment at follow-up
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 19 Jul 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal-assisted trauma-focused therapy and Standard trauma-focused therapy in people with Motivation and Alliance, Therapeutic, run by University of Basel at 2 sites 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 7 inclusion and 7 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 19 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 2 sites 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) 061 207 65 80, karin.hediger@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Therapy Motivation of children and adolescents from baseline to four weeks after treatment. (time frame: before treatment (baseline), after 10 weeks of treatment (post-measurement), four weeks after treatment (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2024.