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Recruiting NCT05608551

Animal-assisted Trauma-focused Therapy for Children and Adolescents

No phase Interventional Motivation Alliance, Therapeutic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Animal-assisted trauma-focused therapy, Standard trauma-focused therapy.
Who it may be relevant to
Registry conditions: Motivation, Alliance, Therapeutic. Basic parameters: 9 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Change of Therapy Motivation of children and adolescents from baseline to four weeks after treatment. [Time frame: before treatment (baseline), after 10 weeks of treatment (post-measurement), four weeks after treatment (follow-up)]
Secondary outcome measures (5)
  • Change of Therapeutic alliance of children and adolescents from baseline to four weeks after treatment. [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. [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. [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. [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. [Time frame: four weeks after treatment at follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 2 centers
  • University of Basel — Basel
  • Psychiatrische Universitätsklinik Zürich — Zurich

Identifiers

NCT: NCT05608551 · 2022-01327

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗