Animal-assisted Trauma-focused Therapy for Children and Adolescents
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-17
SponsorUniversity of Basel
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Animal-assisted trauma-focused therapy
BehavioralAnimal-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 therapy
BehavioralStandard trauma-focused therapy (AA TF-CBT) is a standardized trauma therapy following a structured manual.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: AA TF-CBTExperimental treatment 1 intervention
Group B: TF-CBTActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
before treatment (baseline), after 10 weeks of treatment (post-measurement), four weeks after treatment (follow-up)Secondary outcomes
1
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.
Time frame
before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)2
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.
Time frame
before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)3
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.
Time frame
before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)4
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.
Time frame
before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Basel
Lead sponsor
University of Zurich
Collaborator
Source ClinicalTrials.gov