Dog Assisted Therapy: Comparing Duration Treatments for Patients with Fetal Alcohol Spectrum Disorder

January 7, 2025 updated by: Hospital Universitari Vall d'Hebron Research Institute

A Randomised Controlled Study of Dog Assisted Therapy: Comparing a Short and a Long Version Program for Patients with Fetal Alcohol Spectrum Disorder.

The objective of the present study was to assess the efficacy of a shorter version program of Dog Assisted Therapy (DAT) (8 sessions) compared to a longer version (16 sessions) for children and adolescents with Fetal Alcohol Syndrome (FASD). We evaluated the impact of DAT on social skills, internalizing and externalizing problems, quality of life, severity of the disorder and emotional well-being of parents. We conducted a randomized controlled trial in a cohort of 55 patients with FASD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

FASD can be classified into three subtypes. FAS is identified by (1) facial abnormalities, (2) growth deficits, abnormal brain development, or irregularities in neurophysiology, and (3) neurobehavioral issues. Partial Fetal Alcohol Spectrum Disorder (FASD) shares similarities but presents with fewer physical characteristics, while Alcohol-Related Neurobehavioral Disorder (ARND) solely exhibits neurobehavioral symptoms without facial anomalies.

Previous research has highlighted the effectiveness of psychological intervention programs focused on emotional regulation for individuals with FASD. Similarly, studies have emphasized the benefits of interventions targeting social skills. These interventions have been shown to result in reductions in externalizing behaviors, with social skills training specifically correlating with improvements in social competence and a decrease in problematic behaviors Recently a new form of behavioral therapy has been gaining popularity in improving the physical and mental health of young adults, known as Animal Assisted Therapy (AAT). Animal Assisted Therapy lays its foundation in human attachment theory and social cognitive theory where it is argued that animals can be potentially viewed as a transitional attachment object and thus aid to improve psychosocial functioning.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:all participants needed to have stable doses of medication for at least two months before the study and agree not to seek out any other psychiatric or psychological treatment during the study.

-

Exclusion Criteria:Patients who were not behaviorally stable, presented agressive behavior or required more intensive treatment (hospitalization or day hospital) were excluded.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A Randomised Controlled Study Of Dog Assisted Therapy
We tested 8 week dog assisted therapy for patients with FASD vs 16 week treatment for patients with FASD
Behavioral: Dog assisted therapy - animal interventions
Animal Assisted Therapy is when animals are used in goal directed treatment sessions. These goals are working emotionalaspects pf childres and adolescents with SAF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wechsler Intelligence Scale for Children
Time Frame: Once- Pre intervention week 1 - Post intervention in week 16
Intellectual Quotient
Once- Pre intervention week 1 - Post intervention in week 16
Child Behavior Checklist (CBCL by Achenbach)
Time Frame: Once- Pre intervention week 1 - Post intervention in week 16
Internalizing/ Externalizing Symptoms maximum scores for symptom severity 113
Once- Pre intervention week 1 - Post intervention in week 16
Social Skills Improvement System-Parent Form (SSIS-P)
Time Frame: Once- Pre intervention week 1 - Post intervention in week 16
Social skills assessment - 0 to 60 max scotring
Once- Pre intervention week 1 - Post intervention in week 16
KidScreen 27- 0 maximum 135 - highest severity symptoms at 135
Time Frame: Once- Pre intervention week 1 - Post intervention in week 16
Quality of life assesment
Once- Pre intervention week 1 - Post intervention in week 16
Clinical Global Impression Scale for Severity.0 to 7 (7 most severely ill).
Time Frame: Once- Pre intervention week 1 - Post intervention in week 16
Severity of FASD symptoms
Once- Pre intervention week 1 - Post intervention in week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborators

Fundacion Probitas

Investigators

  • Study Director: Josep Antoni Ramos Quirogfa, MD-PHD, Comitè Ètic d'Investigació Clínica HUVH Barcelona, Barcelona Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2022

Primary Completion (Actual)

August 20, 2023

Study Completion (Actual)

August 20, 2023

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 7, 2025

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAT-VH-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data collected from the patients evaluated in our hospital will be stored in the medical records of Vall d'Hebron University Hospital, as well as in a computerized database that allows for analysis. Rigorous confidentiality of the data will be maintained in accordance with current regulations in Spain (Ley Orgánica de Protección de Datos). To analyze the final data from the three hospitals, each patient will be coded (anonymous code) to facilitate data processing.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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