Animal-assisted Trauma-focused Therapy for Children and Adolescents

NCT05608551 | Recruiting

• 1 other identifier: 2022-01327
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Motivation; Alliance, Therapeutic

Keywords

PTSD; animal-assisted therapy; trauma-focused therapy; motivation

Outcome Measures

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.

  before treatment (baseline), after 10 weeks of treatment (post-measurement), four weeks after treatment (follow-up)

Secondary Outcomes (5)

• Change of Therapeutic alliance of children and adolescents from baseline to four weeks after treatment.

  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.

  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.

  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.

  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.

  four weeks after treatment at follow-up

Study Arms (2)

AA TF-CBT

EXPERIMENTAL

Participants receive a 10-week animal-assisted trauma-focused group therapy.

Behavioral: Animal-assisted trauma-focused therapy

TF-CBT

ACTIVE COMPARATOR

Participants receive a 10-week standard trauma-focused group therapy.

Behavioral: Standard trauma-focused therapy

Interventions

Animal-assisted trauma-focused therapy BEHAVIORAL

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.

AA TF-CBT

Standard trauma-focused therapy BEHAVIORAL

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

TF-CBT

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Inability to complete questionnaires due to lack of language skills or cognitive impairment
• 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

Sponsors & Collaborators

• University of Basel: lead
• University of Zurich: collaborator

Study Sites (2)

University of Basel

Basel, Switzerland

RECRUITING

Psychiatrische Universitätsklinik Zürich

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Karin Hediger, Prof. Dr.

CONTACT

(+41) 061 207 65 80; karin.hediger@unibas.ch

Wanda Arnskötter, MSc.

CONTACT

(+41) 61 207 65 83; wanda.arnskoetter@unibas.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: November 8, 2022
• Study Start: October 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 19, 2024

Record last verified: 2024-07

Locations

CH (2)