Dog-Assisted Therapy for Children and Adolescents With FASD

Sponsor

Hospital Universitari Vall d'Hebron Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04038164

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
FASD	Behavioral: Dog-Assisted Therapy and pharmacological treatment	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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).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 (Outcomes Assessor)

Masking Description:

Rater-blinded

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 2, 2018

Actual Primary Completion Date :

Apr 2, 2019

Actual Study Completion Date :

Apr 2, 2019

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Change from baseline on Social skills at 3 months [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 [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 [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) .

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vall d'Hebron Research Institute	Barcelona		Spain	08035

Sponsors and Collaborators

Hospital Universitari Vall d'Hebron Research Institute

Investigators

Principal Investigator: Raquel Vidal, Hospital Vall d'Hebron

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospital Universitari Vall d'Hebron Research Institute

ClinicalTrials.gov Identifier:

NCT04038164

Other Study ID Numbers:

PR(AG)94/2018

First Posted:

Jul 30, 2019

Last Update Posted:

Jul 30, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute

FASD

animal-assisted therapy

dog-assisted therapy

Additional relevant MeSH terms:

Fetal Alcohol Spectrum Disorders

Study Results

No Results Posted as of Jul 30, 2019