Clinical trial NCT04038164: Dog-Assisted Therapy for Children and Adolescents With FASD
Official title: Dog-Assisted Therapy for Children and Adolescents With FASD: a Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: FASD
Keywords: FASD
animal-assisted therapy
dog-assisted therapy
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 39
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The design was a randomized, rater-blinded, controlled pilot trial. Participants were randomly assigned either to DAT group (n=17) or Treatment as Usual (TAU control group) (n=16).
Primary purpose: TREATMENT

Brief summary: The rationale of the present study was to evaluate the efficacy of DAT in children and adolescents with FASD in relation to its effects on social skills, internalized and externalized symptomatology and on severity of FASD symptoms. This objective was accomplished through a randomized controlled pilot study of DAT for children and adolescents with FASD.

Detailed description: The rationale of this study was to evaluate the efficacy of Dog Assisted Therapy in children and adolescents with FASD. The investigators conducted a randomized, rater-blinded, controlled pilot trial in a cohort of 33 children and adolescents with FASD. Participants were randomly assigned either to DAT group (n=17) or Treatment as Usual (TAU control group) (n=16). The investigators evaluated changes on social skills, internalized and externalized symptomatology and on severity of FASD symptoms at pre-treatment and post-treatment.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with FASD between 6 and 18 years (FAS, pFAS or ARND)
* With or without comorbidities
* Stabilized doses of medication for at least 2 months before the study
* Patients with borderline IQ or mental retardation.

Exclusion Criteria:

* Patients who were not behaviorally stable
* Patients that required hospitalization, day hospital or more intensive treatments.

Primary outcomes:
measure: Change from baseline on Social skills at 3 months
timeFrame: Pre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months)
measure: Change from baseline on Externalizing symptoms at 3 months
timeFrame: Pre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months)
measure: Change from baseline FASD severity at 3 months
timeFrame: Pre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebron Research Institute
Study officials:
affiliation: Hospital Vall d'Hebron
name: Raquel Vidal
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vidal R, Vidal L, Ristol F, Domenec E, Segu M, Vico C, Gomez-Barros N, Ramos-Quiroga JA. Dog-Assisted Therapy for Children and Adolescents With Fetal Alcohol Spectrum Disorders a Randomized Controlled Pilot Study. Front Psychol. 2020 May 26;11:1080. doi: 10.3389/fpsyg.2020.01080. eCollection 2020.