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Dog-Assisted Therapy for Children and Adolescents With FASD

Dog-Assisted Therapy for Children and Adolescents With FASD: a Randomized Controlled Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04038164
Enrollment
39
Registered
2019-07-30
Start date
2018-04-02
Completion date
2019-04-02
Last updated
2019-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

FASD

Keywords

FASD, animal-assisted therapy, dog-assisted therapy

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.

Interventions

BEHAVIORALDog-Assisted Therapy and pharmacological treatment

The investigators used the CTAC Method (Center of Dog Assisted Therapy) (E Domènec 2012).

Sponsors

Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Rater-blinded

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).

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline on Social skills at 3 monthsPre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months)Social Skills Improvement System-Parent Form (SSIS-P). is a 79 items scale (Likert scale 0 to 4) measuring social skills and problem behaviors in children and adolescents as reported by their parents. In the Social Skills domain, the subscales are communication, cooperation, assertion, responsibility, empathy, engagement, and self-control. The Problem Behaviors domain includes internalizing and externalizing problems, bullying, hyperactivity/inattention and autism spectrum.
Change from baseline on Externalizing symptoms at 3 monthsPre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months)Child Behavior Checklist (CBCL of Achenbach) parent version. to assess Internalizing and Externalizing Symptoms in patients between 4 and 18 years. The CBCL is a 113 item scale (Likert scale: 0-2) which assesses withdrawn symptoms, somatic complains, anxiety/depressive symptoms, thought problems, ADHD features, oppositional behavior and behavioral problems. Higher scores indicate more conduct problems.
Change from baseline FASD severity at 3 monthsPre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months)Clinical Global Impression Scale for Severity(CGI-S Clinician). The Clinical Global Impression Scale for Severity (CGI-S): is a 7-point scale (1 = normal or not ill, and 7 = extremely ill) .

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026