Dog-Assisted Therapy for Children and Adolescents With FASD

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

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.

Study Overview

• Status: Completed
• Conditions: FASD
• Intervention / Treatment: Behavioral: Dog-Assisted Therapy and pharmacological treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Vall d'Hebron Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dog-Assisted Therapy (DAT) and pharmacological treatment; 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; The investigators used the CTAC Method (Center of Dog Assisted Therapy) (E Domènec 2012).
ACTIVE_COMPARATOR: Treatment as usual (TAU, pharmacological treatment); 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; The investigators used the CTAC Method (Center of Dog Assisted Therapy) (E Domènec 2012).

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)

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Investigators: Principal Investigator: Raquel Vidal, Hospital Vall D'Hebron

Publications and helpful links

General Publications

• Vidal R, Vidal L, Ristol F, Domenec E, Segu M, Vico C, Gomez-Barros N, Ramos-Quiroga JA. Dog-Assisted Therapy for Children and Adolescents With Fetal Alcohol Spectrum Disorders a Randomized Controlled Pilot Study. Front Psychol. 2020 May 26;11:1080. doi: 10.3389/fpsyg.2020.01080. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 2, 2018
• Primary Completion (ACTUAL): April 2, 2019
• Study Completion (ACTUAL): April 2, 2019

Study Registration Dates

• First Submitted: June 28, 2019
• First Submitted That Met QC Criteria: July 29, 2019
• First Posted (ACTUAL): July 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: FASD; animal-assisted therapy; dog-assisted therapy
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Fetal Diseases; Pregnancy Complications; Alcohol-Induced Disorders; Fetal Alcohol Spectrum Disorders
• Other Study ID Numbers: PR(AG)94/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No