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Dog-Assisted Therapy for Children and Adolescents With FASD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038164
Recruitment Status : Completed
First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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).
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 : April 2, 2018
Actual Primary Completion Date : April 2, 2019
Actual Study Completion Date : April 2, 2019

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).




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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) .



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038164


Locations
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Spain
Vall d'Hebron Research Institute
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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Principal Investigator: Raquel Vidal Hospital Vall d'Hebron
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT04038164    
Other Study ID Numbers: PR(AG)94/2018
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
FASD
animal-assisted therapy
dog-assisted therapy
Additional relevant MeSH terms:
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Fetal Alcohol Spectrum Disorders
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders