Dog Assisted Therapy: Comparing Duration Treatments for Patients with Fetal Alcohol Spectrum Disorder
A Randomised Controlled Study of Dog Assisted Therapy: Comparing a Short and a Long Version Program for Patients with Fetal Alcohol Spectrum Disorder.
1 other identifier
interventional
55
1 country
1
Brief Summary
The objective of the present study was to assess the efficacy of a shorter version program of Dog Assisted Therapy (DAT) (8 sessions) compared to a longer version (16 sessions) for children and adolescents with Fetal Alcohol Syndrome (FASD). We evaluated the impact of DAT on social skills, internalizing and externalizing problems, quality of life, severity of the disorder and emotional well-being of parents. We conducted a randomized controlled trial in a cohort of 55 patients with FASD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2023
CompletedFirst Submitted
Initial submission to the registry
July 22, 2024
CompletedFirst Posted
Study publicly available on registry
January 8, 2025
CompletedJanuary 8, 2025
July 1, 2023
1.5 years
July 22, 2024
January 7, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Wechsler Intelligence Scale for Children
Intellectual Quotient
Once- Pre intervention week 1 - Post intervention in week 16
Child Behavior Checklist (CBCL by Achenbach)
Internalizing/ Externalizing Symptoms maximum scores for symptom severity 113
Once- Pre intervention week 1 - Post intervention in week 16
Social Skills Improvement System-Parent Form (SSIS-P)
Social skills assessment - 0 to 60 max scotring
Once- Pre intervention week 1 - Post intervention in week 16
KidScreen 27- 0 maximum 135 - highest severity symptoms at 135
Quality of life assesment
Once- Pre intervention week 1 - Post intervention in week 16
Clinical Global Impression Scale for Severity.0 to 7 (7 most severely ill).
Severity of FASD symptoms
Once- Pre intervention week 1 - Post intervention in week 16
Study Arms (1)
A Randomised Controlled Study Of Dog Assisted Therapy
EXPERIMENTALWe tested 8 week dog assisted therapy for patients with FASD vs 16 week treatment for patients with FASD
Interventions
Animal Assisted Therapy is when animals are used in goal directed treatment sessions. These goals are working emotionalaspects pf childres and adolescents with SAF
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, 08035, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Josep Antoni Ramos Quirogfa, MD-PHD
Comitè Ètic d'Investigació Clínica HUVH Barcelona, Barcelona Spain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2024
First Posted
January 8, 2025
Study Start
February 20, 2022
Primary Completion
August 20, 2023
Study Completion
August 20, 2023
Last Updated
January 8, 2025
Record last verified: 2023-07