Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT05608551
Status:
RECRUITING
Last Update Posted:
2024-07-19
First Post:
2022-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Animal-assisted Trauma-focused Therapy for Children and Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2028-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2022-09-08', 'studyFirstSubmitQcDate': '2022-10-31', 'lastUpdatePostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Therapy Motivation of children and adolescents from baseline to four weeks after treatment.', 'timeFrame': 'before treatment (baseline), after 10 weeks of treatment (post-measurement), four weeks after treatment (follow-up)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change of Therapeutic alliance of children and adolescents from baseline to four weeks after treatment.', 'timeFrame': 'before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)', 'description': '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.'}, {'measure': 'Change of PTSD symptoms of children and adolescents from baseline to four weeks after treatment.', 'timeFrame': 'before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)', 'description': '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.'}, {'measure': 'Change of Self-efficacy of children and adolescents from baseline to four weeks after treatment.', 'timeFrame': 'before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)', 'description': '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.'}, {'measure': 'Change of Quality of Life of children and adolescents from baseline to four weeks after treatment.', 'timeFrame': 'before treatment (baseline), after ten weeks of treatment (post-measurement), four weeks after treatment (follow-up)', 'description': '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.'}, {'measure': "Qualitative assessment of participants' perception of the group therapy at follow-up.", 'timeFrame': 'four weeks after treatment at follow-up', 'description': 'Participants perception is assessed at follow-up using a semi-structured interview.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PTSD', 'animal-assisted therapy', 'trauma-focused therapy', 'motivation'], 'conditions': ['Motivation', 'Alliance, Therapeutic']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 9 and 17 years\n* experienced a traumatic event\n* remembers at least one traumatic event\n* Suffering from posttraumatic stress symptoms (screened via the CATS-2; cut-off ≥ 21; cut-off must be reached by either participant or caregiver)\n* Basic knowledge of child and parents in German to be able to understand content of the session and to fill in questionnaires\n* Informed consent (given by legal guardian for participants younger than 14 years)\n* Positive or neutral attitude towards animals\n\nExclusion Criteria:\n\n* Inability to complete questionnaires due to lack of language skills or cognitive impairment\n* Diagnosed autism spectrum disorder; Exclusion only if interaction with others and group ability is limited due to autism\n* Reported significant impairment or safety issue (e.g., active suicidal ideation, acute psychosis)\n* Known abuse of substances used for emotion regulation (e.g. cannabis, alcohol, other hard drugs)\n* Fear of domestic animals\n* Allergic reactions to domestic animals\n* Reported aggressive behavior towards animals in the past'}, 'identificationModule': {'nctId': 'NCT05608551', 'acronym': 'AA TF-CBT', 'briefTitle': 'Animal-assisted Trauma-focused Therapy for Children and Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University of Basel'}, 'officialTitle': 'Effects of a Psychotherapy Group Program for Children and Adolescents With Post-traumatic Stress Symptoms', 'orgStudyIdInfo': {'id': '2022-01327'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AA TF-CBT', 'description': 'Participants receive a 10-week animal-assisted trauma-focused group therapy.', 'interventionNames': ['Behavioral: Animal-assisted trauma-focused therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TF-CBT', 'description': 'Participants receive a 10-week standard trauma-focused group therapy.', 'interventionNames': ['Behavioral: Standard trauma-focused therapy']}], 'interventions': [{'name': 'Animal-assisted trauma-focused therapy', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['AA TF-CBT']}, {'name': 'Standard trauma-focused therapy', 'type': 'BEHAVIORAL', 'description': 'Standard trauma-focused therapy (AA TF-CBT) is a standardized trauma therapy following a structured manual.', 'armGroupLabels': ['TF-CBT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Karin Hediger', 'role': 'CONTACT', 'email': 'karin.hediger@unibas.ch'}], 'facility': 'University of Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Susanne Walitza', 'role': 'CONTACT', 'email': 'susanne.walitza@puk.zh.ch'}], 'facility': 'Psychiatrische Universitätsklinik Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Karin Hediger, Prof. Dr.', 'role': 'CONTACT', 'email': 'karin.hediger@unibas.ch', 'phone': '(+41) 061 207 65 80'}, {'name': 'Wanda Arnskötter, MSc.', 'role': 'CONTACT', 'email': 'wanda.arnskoetter@unibas.ch', 'phone': '(+41) 61 207 65 83'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Basel', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Zurich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Dr. Karin Hediger', 'investigatorAffiliation': 'University of Basel'}}}}