Dog-Assisted Therapy for Children and Adolescents With FASD

FASD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04038164
• Other study ID #: PR(AG)94/2018
• Status: Completed
• Phase: N/A
• Start date: April 2, 2018
• Est. completion date: April 2, 2019

Study information

• Verified date: July 2019
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2, 2019
• Est. primary completion date: April 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• FASD

Intervention

Behavioral:
• Dog-Assisted Therapy and pharmacological treatment
The investigators used the CTAC Method (Center of Dog Assisted Therapy) (E Domènec 2012).

Locations

Country	Name	City	State
Spain	Vall d'Hebron Research Institute	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)