An interventional study of Animal-assisted trauma-focused therapy and Standard trauma-focused therapy in Motivation and Alliance, Therapeutic, sponsored by University of Basel. Recruiting at 2 sites in Switzerland. Open to participants aged 9 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-07-19.
Sponsored by University of Basel · Not applicable, Interventional, and Treatment
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.
2,284 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 557 are open to participants now.
This study's planned enrollment of 80 is above the median of 70 across 1,897 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →University of Basel is the lead sponsor of 62 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants receive a 10-week animal-assisted trauma-focused group therapy.
Behavioral: Animal-assisted trauma-focused therapy
Participants receive a 10-week standard trauma-focused group therapy.
Behavioral: Standard trauma-focused therapy
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 therapy (AA TF-CBT) is a standardized trauma therapy following a structured manual.
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)
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)
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)
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)
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)
Qualitative assessment of participants' perception of the group therapy at follow-up.
Participants perception is assessed at follow-up using a semi-structured interview.
Time frame: four weeks after treatment at follow-up
Started Oct 2022 (actual). Primary completion is estimated for Dec 2025, 38 months after the start.
Of 911 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 38 months is close to that.
Counting every sponsor, half of 937 studies reached it within 35 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Stress Disorders, Post-Traumatic →
University of Basel