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NCT Number: NCT05608551

Animal-assisted Trauma-focused Therapy for Children and Adolescents

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.

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Key information

Age range

9 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Basel, Basel, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard trauma-focused therapy

Behavioral

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

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. 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)

    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.

  2. 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)

    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.

  3. 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)

    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.

  4. 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)

    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.

  5. Qualitative assessment of participants' perception of the group therapy at follow-up.

    Time frame: four weeks after treatment at follow-up

    Participants perception is assessed at follow-up using a semi-structured interview.

Study contacts

Contact information is provided by the study sponsor or research team.

Karin Hediger, Prof. Dr.

CONTACT

[email protected]

(+41) 061 207 65 80

Wanda Arnskötter, MSc.

CONTACT

[email protected]

(+41) 61 207 65 83

Sponsors and collaborators

Lead sponsor

University of Basel

Other

Collaborators

  • University of Zurich

Registry information

Official study title

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

Acronym: AA TF-CBT

Important dates

Study start
2022
Primary completion
2025
Study completion
2028
First posted
Nov 8, 2022
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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