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临床试验/NCT05608551
NCT05608551招募中不适用

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

University of Basel3 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
3
主要终点
Change of Therapy Motivation of children and adolescents from baseline to four weeks after treatment.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
9 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change of Therapy Motivation of children and adolescents from baseline to four weeks after treatment.

时间窗: 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.

次要结局

  • 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 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))
  • 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 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))
  • Qualitative assessment of participants' perception of the group therapy at follow-up.(four weeks after treatment at follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Karin Hediger

Prof. Dr.

University of Basel

研究点 (3)

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