Animal-assisted Trauma-focused Therapy for Children and Adolescents

Motivation Clinical Trial

— AA TF-CBT  

Official title:

Effects of a Psychotherapy Group Program for Children and Adolescents With Post-traumatic Stress Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05608551
• Other study ID #: 2022-01327
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: October 2022
• Source: University of Basel
• Contact: Karin Hediger, Prof. Dr.
• Phone: (+41) 061 207 65 80
• Email: karin.hediger[@]unibas.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

Inclusion Criteria:

• Age between 9 and 17 years

• experienced a traumatic event

• Suffering from posttraumatic stress symptoms (screened via the CATS-2; cut-off = 21)

• 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:

• Diagnosed developmental disorder

• Diagnosed autism spectrum disorder

• 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

Related Conditions & MeSH terms

• Motivation

Intervention

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.
• Standard trauma-focused therapy
Standard trauma-focused therapy (AA TF-CBT) is a standardized trauma therapy following a structured manual.

Locations

Country	Name	City	State
Switzerland	University of Basel	Basel
Switzerland	Psychiatrische Universitätsklinik Zürich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University of Basel	University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)