Animal-assisted Trauma-focused Therapy for Children and Adolescents (AA TF-CBT)

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.

Study Overview

• Status: Recruiting
• Conditions: Motivation; Alliance, Therapeutic
• Intervention / Treatment: Behavioral: Animal-assisted trauma-focused therapy; Behavioral: Standard trauma-focused therapy

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karin Hediger, Prof. Dr.; Phone Number: (+41) 061 207 65 80; Email: karin.hediger@unibas.ch
• Study Contact Backup: Name: Wanda Arnskötter, MSc.; Phone Number: (+41) 61 207 65 83; Email: wanda.arnskoetter@unibas.ch

Study Locations

• Switzerland
  • Basel, Switzerland
    • Recruiting
    • University of Basel
    • Contact: Karin Hediger; Email: karin.hediger@unibas.ch
  • Zürich, Switzerland
    • Recruiting
    • Psychiatrische Universitätsklinik Zürich
    • Contact: Susanne Walitza; Email: susanne.walitza@puk.zh.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AA TF-CBT; Participants receive a 10-week animal-assisted trauma-focused group therapy.	Behavioral: Animal-assisted 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.
Active Comparator: TF-CBT; Participants receive a 10-week standard trauma-focused group therapy.	Behavioral: Standard trauma-focused therapy; Standard trauma-focused therapy (AA TF-CBT) is a standardized trauma therapy following a structured manual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	before treatment (baseline), after 10 weeks of treatment (post-measurement), four weeks after treatment (follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	four weeks after treatment at follow-up

Collaborators and Investigators

• Sponsor: University of Basel
• Collaborators: University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: October 31, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: PTSD; motivation; animal-assisted therapy; trauma-focused therapy
• Other Study ID Numbers: 2022-01327

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No