Dog-Assisted Therapy for Children and Adolescents With FASD

Study 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.

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

Conditions
-----------------
FASD

Intervention / Treatment
-----------------
* Behavioral: Dog-Assisted Therapy and pharmacological treatment


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dog-Assisted Therapy (DAT) and pharmacological treatment<br>The DAT program comprised 12 manualized sessions and included two phases: 1) individual intervention (6 sessions) and 2) group activity (6 sessions). Patients participated in weekly sessions for about 3 months. Each session lasted 45 minutes. The groups were formed by 3-4 patients. Sessions included the participation of two certified therapy dogs, two technicians specialized in DAT and a psychologist. Participants in this group were visited by their psychiatrist in order to monitor their adherence to medications. | Behavioral: Dog-Assisted Therapy and pharmacological treatment<br>* The investigators used the CTAC Method (Center of Dog Assisted Therapy) (E Domènec 2012).<br>|
| Active Comparator: Treatment as usual (TAU, pharmacological treatment)<br>Participants received their usual treatment. They were visited by their psychiatrist in order to monitor their adherence and continuation on medications as prescribed. Inclusion and exclusion criteria were the same as for the experimental group. Participants in the TAU group did not receive DAT sessions. | Behavioral: Dog-Assisted Therapy and pharmacological treatment<br>* The investigators used the CTAC Method (Center of Dog Assisted Therapy) (E Domènec 2012).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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) . | Pre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FASD, animal-assisted therapy, dog-assisted therapy