Clinical trial NCT05608551: Animal-assisted Trauma-focused Therapy for Children and Adolescents
Official title: Effects of a Psychotherapy Group Program for Children and Adolescents With Post-traumatic Stress Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Motivation
Alliance, Therapeutic
Keywords: PTSD
animal-assisted therapy
trauma-focused therapy
motivation
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2022-11-08
Enrollment: 80
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of Therapy Motivation of children and adolescents from baseline to four weeks after treatment.
timeFrame: before treatment (baseline), after 10 weeks of treatment (post-measurement), four weeks after treatment (follow-up)
Secondary outcomes:
measure: Change of Therapeutic alliance of children and adolescents from baseline to four weeks after treatment.
timeFrame: before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)
measure: Change of PTSD symptoms of children and adolescents from baseline to four weeks after treatment.
timeFrame: before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)
measure: Change of Self-efficacy of children and adolescents from baseline to four weeks after treatment.
timeFrame: before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)
measure: Change of Quality of Life of children and adolescents from baseline to four weeks after treatment.
timeFrame: before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)
measure: Qualitative assessment of participants' perception of the group therapy at follow-up.
timeFrame: four weeks after treatment at follow-up
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel
city: Zürich
country: Switzerland
facility: Psychiatrische Universitätsklinik Zürich
Study officials:
References: