Dog-Assisted Therapy for Children and Adolescents With FASD

Hospital Universitari Vall d'Hebron Research Institute39 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

FASD

Interventions

Dog-Assisted Therapy and pharmacological treatmentBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Vall d'Hebron Research Institute

Barcelona, Spain

Outcomes

Primary Outcomes

Change from baseline on Social skills 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.

Time frame: Pre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months)

Change from baseline on Externalizing symptoms 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.

Time frame: Pre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months)

Change from baseline FASD severity 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) .

Time frame: Pre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months)

Data from ClinicalTrials.gov

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