Clinical trial NCT06763614: Dog Assisted Therapy: Comparing Duration Treatments for Patients with Fetal Alcohol Spectrum Disorder
Official title: A Randomised Controlled Study of Dog Assisted Therapy: Comparing a Short and a Long Version Program for Patients with Fetal Alcohol Spectrum Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorders
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Fundacion Probitas
First posted: 2025-01-08
Enrollment: 55
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: FASD can be classified into three subtypes. FAS is identified by (1) facial abnormalities, (2) growth deficits, abnormal brain development, or irregularities in neurophysiology, and (3) neurobehavioral issues. Partial Fetal Alcohol Spectrum Disorder (FASD) shares similarities but presents with fewer physical characteristics, while Alcohol-Related Neurobehavioral Disorder (ARND) solely exhibits neurobehavioral symptoms without facial anomalies.

Previous research has highlighted the effectiveness of psychological intervention programs focused on emotional regulation for individuals with FASD. Similarly, studies have emphasized the benefits of interventions targeting social skills. These interventions have been shown to result in reductions in externalizing behaviors, with social skills training specifically correlating with improvements in social competence and a decrease in problematic behaviors Recently a new form of behavioral therapy has been gaining popularity in improving the physical and mental health of young adults, known as Animal Assisted Therapy (AAT). Animal Assisted Therapy lays its foundation in human attachment theory and social cognitive theory where it is argued that animals can be potentially viewed as a transitional attachment object and thus aid to improve psychosocial functioning.

Eligibility criteria: Inclusion Criteria:all participants needed to have stable doses of medication for at least two months before the study and agree not to seek out any other psychiatric or psychological treatment during the study.

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Exclusion Criteria:Patients who were not behaviorally stable, presented agressive behavior or required more intensive treatment (hospitalization or day hospital) were excluded.

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Primary outcomes:
measure: Wechsler Intelligence Scale for Children
timeFrame: Once- Pre intervention week 1 - Post intervention in week 16
measure: Child Behavior Checklist (CBCL by Achenbach)
timeFrame: Once- Pre intervention week 1 - Post intervention in week 16
measure: Social Skills Improvement System-Parent Form (SSIS-P)
timeFrame: Once- Pre intervention week 1 - Post intervention in week 16
measure: KidScreen 27- 0 maximum 135 - highest severity symptoms at 135
timeFrame: Once- Pre intervention week 1 - Post intervention in week 16
measure: Clinical Global Impression Scale for Severity.0 to 7 (7 most severely ill).
timeFrame: Once- Pre intervention week 1 - Post intervention in week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
affiliation: Comitè Ètic d'Investigació Clínica HUVH Barcelona, Barcelona Spain
name: Josep Antoni Ramos Quirogfa, MD-PHD
role: STUDY_DIRECTOR
References: