Dog-Assisted Therapy for Children and Adolescents With FASD: a Randomized Controlled Pilot Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- FASD
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Change from baseline on Social skills at 3 months
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Change from baseline on Social skills at 3 months
Time Frame: Pre-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 months
Time Frame: Pre-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 months
Time Frame: Pre-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) .