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Completed

NCT Number: NCT04038164

Dog-Assisted Therapy for Children and Adolescents With FASD

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.

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Key information

Conditions

FASD Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Alcohol Spectrum Disorders Fetal Diseases Pregnancy Complications Substance-Related Disorders Urogenital Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vall d'Hebron Research Institute

Barcelona, 08035, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dog-Assisted Therapy and pharmacological treatment

Behavioral

The investigators used the CTAC Method (Center of Dog Assisted Therapy) (E Domènec 2012).

Primary outcomes

  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) .

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 30, 2019
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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